Medical Devices
14. Storage, Distribution and Installation
INTRODUCTION
Holding and Distribution Procedures
Warehouse Storage
Distribution Records
DEVICE INSTALLATION
EXHIBITS
Finished Product Release Form
Release To Finished Goods/Shipping
Product Shipping Hold
Release From Product Shipping Hold
Partial List of Traceable Devices
INTRODUCTION
The device Quality System (QS) regulation covers the manufacture, storage (820.150), distribution (820.160) and installation (820.170) of finished devices. For manufacturers and importers, distribution is one of the most important steps in their quality system. After a product is distributed, a manufacturer rarely has direct control over the product or how it is used. Thus, it is important that controls be in place to assure that only correctly labeled, packaged and approved finished devices are distributed and, if necessary, installed.
Holding and Distribution Procedures
Section 820.160 requires that the purchase order be reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Manufacturers should have a program to reduce problems in this area. Marketing personnel should be adequately trained. Sales specification flyers and catalogs should be carefully written and kept current to reduce ordering problems. Incoming purchase orders should be checked and ambiguities and errors resolved. After receipt by appropriately trained personnel, orders should be reviewed immediately. If purchase orders are reviewed late in the manufacturing process or just before distribution, the value of the review may be significantly reduced. Where the customer includes specifications, each specified parameter should be checked against the corresponding parameter for the device. A checklist of device parameters may be a helpful tool for this review and should be filed with, or keyed to, the purchase order.
The QS regulation (820.60), Identification, requires manufacturers to set up and maintain identity control of their products from component receipt, production, distribution and through installation to prevent mixups. The regulation also requires that written procedures be provided for control and distribution of finished devices (820.160). The purpose of this requirement is to assure that only approved devices are distributed. Each manufacturer should determine what written procedures are needed to assure that only "approved for release" devices are distributed from the manufacturer. If a manufacturer believes written procedures will not contribute to assuring that only Aapproved for release@ devices are distributed by their manufacturer, they should be able to defend their decision. For example, the control is integrated into the activities required to package the device or to complete the device history record. This flexibility is allowed by section 820.5, Quality system, of the QS regulation.
Many manufacturers mark their released finished devices or identify them by location or packaging so that a simple visual check is sufficient to indicate whether the product is acceptable to release for distribution. For example, radiation-emitting electronic products are subject to a performance standard. The application of the certification label is often the last step in approving product release for distribution, and this label is used to distinguish such devices. After final release, the crating of large equipment is a very distinguishing feature. These types of operations may preclude the need for a separate written procedure.
For interstate contract sterilization, 21 C.F.R. section 801.150(e) requires a written agreement between the parties which details the necessary procedures to help prevent the erroneous release of packaged and labeled "sterile" but not yet sterilized devices that appear to be, but are not, ready for release. Regardless of whether 801.150(e) applies, the QS regulation requires controls, as necessary, to prevent mixups in complex situations such as contract sterilization. For consistency, a contract as described by 801.150(e) is commonly used by manufacturers for interstate and intrastate shipments. Compliance with such a contract satisfies the applicable GMP requirements. (See Chapter 10, Purchasing and Acceptance Activities, and Compliance Policy Guide 7382.830B for details.)
Sometimes manufacturers need to ship "finished devices" that have not been officially released because the final test data is not yet available. The critical factor is that the device still remains under the manufacturer=s control. The most common example occurs when a manufacturer is waiting for the results from biological indicator tests. FDA permits manufacturers to ship such devices under quarantine to their own controlled warehouses where the devices may be readily recalled prior to any use, if the need arises. Manufacturers should not ship non-released devices to routine distributors or anyone outside of their direct control. Non-released products or products on "hold" for any quality reason should be controlled to prevent release. A suitable control is quarantine with a label on the units, pallets, etc., to indicate their status.
Warehouse Storage
Storage should always be done under systematic, orderly conditions (820.150). Manufacturers should use a first-in, first-out (FIFO) distribution system when fitness for use of a device deteriorates over time (820.150).
When a controlled environment is necessary to prevent abnormal deterioration, the environment should be specified, controlled, and monitored according to sections 820.70(c) (see Chapter 6, Buildings and Environment). Environmental specifications, such as storage temperature, should be included in the device master record.
The storage and handling of devices to be distributed may involve extensive activities (820.140 and 820.150). For example, damaged, recalled or returned devices should be suitably marked and segregated from devices acceptable for release (820.86). Returned devices should be handled and stored such that the cause of failure or other useful information is not destroyed. Returned defective devices should be formally investigated according to 820.100 Corrective and Preventive Action and any associated complaints investigated according to 820.198. Therefore, manufacturers will need controls to assure that returned defective devices do not dead-end in the warehouse, but are expeditiously routed to the appropriate department for evaluation, investigation, conclusions and follow-up (see Chapter 15, Complaint Files).
Distribution Records
Quality System section 820.184, Device History Record (DHR), requires manufacturers of devices to maintain basic records for:
- dates of manufacture,
- the quantity manufactured,
- quantity released for distribution,
- acceptance records,
- primary identification labels and labeling used, and
- any device identification and control number used.
Section 820.160, Distribution, requires the following records:
- name and address of the initial consignee,
- identification and quantity of devices shipped,
- date shipped, and
- any control number used.
Some of the above information necessary for the distribution records is a duplicate of Device History Record (DHR) requirements. These duplications may be copied or transferred electronically from the DHR. If appropriate, a manufacturer may combine the records by adding the distribution information to the DHR.
In addition to the above requirements, manufacturers of implantable devices and life sustaining devices, the failure of which during use could result in significant injury to the user, are required to establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and, where appropriate, components (820.65). A partial list of traceable devices that meet this definition is printed at the end of this chapter.
Distribution records may be the same as, or part of, the normal business records. Generation of a separate record is not required unless the business records are not readily available, e.g., not maintained at the same establishment as the device history record and not readily retrievable electronically. Many manufacturers, also keep distribution records for billing and market survey purposes.
Manufacturers of radiological electronic products listed in 21 CFR 1002.1, Record and Reporting Requirements By Product, shall maintain distribution records that will enable them to trace specific products or production lots to distributors, or to dealers in those instances in which the manufacturer distributes directly to dealers (See 21 CFR 1002.30, Records to be Maintained by Manufacturers).
Distribution records shall be kept for a period of time equivalent to the design life and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer [820.180(b)]. The intent of this requirement is support for potential repairs, corrective actions and recalls. Each manufacturer should make a prudent decision whether to discard records or keep all, or part, of them for a longer period. When requested, distribution records shall be made available to FDA investigators for review and copying during normal business hours.
DEVICE INSTALLATION
Section 820.170 on installation requires that each manufacturer establish and maintain adequate installation and inspection instructions and, where appropriate, testing procedures. The purpose of this requirement is to ensure that the device is properly installed and will perform as intended after installation. This regulation applies to medical device systems and complex devices that require set up and adjustment at the location where they are to be used. For example, before a diagnostic x-ray machine can be used, it has to be installed and adjusted and the performance checked. Cardiopulmonary bypass machines also require set up and adjustment at the user location. Manufacturers of such devices shall:
- install the device, or have it installed by a representative;
- inspect and test, as appropriate, the device after installation to assure the device will perform as intended; or
- provide adequate instructions and procedures for proper installation by another party.
These instructions and procedures for proper installation by the manufacturer's representative, user, or third party (820.170) shall include instructions on how to determine that the installed device is safe, performing satisfactorily and ready for use. Safety checks at installation refer to safety aspects directly related to the installation and setup activities and not to intrinsic safety features that have already been checked during final acceptance testing at the factory.
The instructions and procedures shall be distributed with the device or otherwise made available to the person installing the device. Such procedures and instructions are part of the device master record and generally include a checklist for the installer to make certain that all necessary installation and checkout activities have been performed correctly. The installer should complete the checklist. If available to the manufacturer, the filled-in checklist or other installation records are part of the device history record.
Installation and servicing are related activities. Therefore, see Chapter 16, Servicing, for more information.
EXHIBITS
Various forms to show that devices are finished and may be released or stopped from release and a list of some traceable devices are briefly described below and then exhibited.
Finished Product Release Form
This exhibit shows an example of a finished product release form which is actually a checklist for the manufacturing and QC departments of an in vitro diagnostic manufacturer to show that all required processes have been completed. The checklist acts as a reminder of the acceptance forms that are needed for a product and has space for the manufacturing and QC people to indicate that these forms have been completed and reviewed. Finally there is space for the designees to approve or disapprove the lot for release and for comments, if needed.
Release To Finished Goods/Shipping
This exhibit is a release form as described above except that it is for various hardware products. The employee writes in the specification for the product being released.
Product Shipping Hold
This exhibit is an example of a form used to stop the shipping of a finished device for reasons related to safety, performance, reliability, regulatory compliance, or other quality requirements.
Release From Product Shipping Hold
This is a form used to release a finished device from a stop shipment order. Because stop orders are always significant, this release form requires a signature by key management.
Partial List of Traceable Devices
This exhibit lists many of the devices for which a manufacturer must adopt a method of device tracking and the citation to 21 C.F.R. for the device.
It is required that implantable devices and life sustaining devices, whose failure during use as described on the label, could result in significant injury to the user, establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices. Where appropriate, this traceability rule also applies to components. These procedures should facilitate corrective action. This identification should be documented in the device history record. Many of these devices were formerly called critical devices.
FINISHED PRODUCT RELEASE |
Form No. |
Rev. |
Sheet 1 of 1 |
|||
Form Approved by: |
Date |
|||||
| ECN notes: | ||||||
| Title: AMYLASE SET | ||||||
| Packaging lot number |
Circle one CATALOG Number AM-389-01 AM-389-02 |
|||||
| The device history documents below were reviewed by 6 Circle one form number in 2, 5 & 7 below. |
MFG | QC | ||||
| 1. Form # 9926 | Product flow sheet | |||||
| 2. Form # 1077 or 1078 | Iodine solution | |||||
| 3. Form # 1082 | Substrate solution | |||||
| 4. Form # 1083 | Substrate tube filling sheet | |||||
| 5. Form # 1084 or 1085 | Iodine filling sheet | |||||
| 6. Form # 1086 | Packaging record | |||||
| 7. Form # QC-PP-07 or QC-PP-01 | Finished device specification | |||||
| Comments | ||||||
| Sign. MFG Designee APP. Yes or No | ||||||
| Comments | ||||||
| Signature QC Designee Approved Yes or No | ||||||
| RELEASE TO FINISHED GOODS/SHIPPING | Form # Release-110 | Rev. B | Sheet 1 of 1 | |||
| Form Approved by: | Date 4-15-1974 | |||||
| ECN notes: | ||||||
| Type of Product: [ ] Cable [ ] Instrument [ ] Spare/Replacement part/assembly | ||||||
| PRODUCT NAME | Part Number | Serial / Lot Number | ||||
| Inspection Specification Number | Revision | |||||
| PRODUCT STATUS | Circle yes or no 9 | |||||
| 1. Final inspection complete per standards set forth in the QC manual and device inspection specification ? | YES | NO | ||||
| 2. Device history record packet present ? | YES | NO | ||||
| If the answer to 1 or 2 is NO, return lot to Production. | ||||||
| 3. Has Final Inspection performed a simulated use test ? | YES | NO | ||||
| 4. An identified final test data sheet is with the unit ? | YES | NO | ||||
| Comments | ||||||
| Signature QC Designee Approved | YES | NO | ||||
| Quantity Released | Date | |||||
| HOLD NUMBER: | DATE: | |
|
PRODUCT SHIPPING HOLD BY QUALITY ASSURANCE DEPARTMENT |
||
| The product listed below is on SHIPPING HOLD and under NO circumstances is to be shipped from the factory or any field office without the written approval of the Director, Quality Assurance. | ||
| PRODUCT: | ||
| HOLD STARTING DATE: | ||
| CLASSIFICATION OF HOLD | ||
|
[ ] EFFICACY [ ] RELIABILITY [ ] STERILITY [ ] OTHER (describe) |
[ ] SAFETY [ ] REGULATORY COMPLIANCE [ ] GOOF UP |
|
| REASON FOR HOLD: | ||
| ACTION REQUIRED BEFORE RELEASE: | ||
| MDR/RECALL NOTES: | ||
| Sign., DIRECTOR, QUALITY ASSURANCE | ||
| DISTRIBUTION: | ||
|
[ ] Manager, Shipping Department [ ] National Field Manager [ ] General Manager [ ] Controller [ ] V.P. Corporate (if s/e problem) |
[ ] Director, Manufacturing [ ] Division President [ ] Director, R & D [ ] Director, Marketing [ ] V.P. International (if int'l sales) |
|
| HOLD NUMBER: | DATE: | |
|
RELEASE FROM PRODUCT SHIPPING HOLD BY QUALITY ASSURANCE DEPARTMENT |
||
| The product listed below is RELEASED from SHIPPING HOLD. | ||
| PRODUCT: | ||
| HOLD RELEASE DATE: | ||
| REASON FOR RELEASE: | ||
| MDR/RECALL NOTES: | ||
| Sign., DIRECTOR, QUALITY ASSURANCE | ||
| DISTRIBUTION: | ||
|
[ ] Manager, Shipping Department [ ] National Field Manager [ ] General Manager [ ] Controller [ ] V.P. Corporate (if S/E) |
[ ] Director, Manufacturing [ ] Division President [ ] Director, R & D [ ] Director, Marketing [ ] V.P. International (if Int'l sales) |
|
| CFR Cite | Classification Name of Device |
| PART 868 -- ANESTHESIOLOGY DEVICES | |
| 868.1200 | Indwelling blood oxygen partial pressure (PO2) analyzer |
| 868.2375 | Breathing frequency monitor |
| 868.5090 | Emergency airway needle |
| 868.5160(a) | Gas machine for anesthesia |
| 868.5240 | Anesthesia breathing circuit |
| 868.5400 | Electroanesthesia apparatus |
| 868.5440 | Portable oxygen generator |
| 868.5470 | Hyperbaric chamber (Monoplace) |
| 868.5610 | Membrane lung for long term pulmonary support |
| 868.5650 | Esophageal obturator |
| 868.5720 | Bronchial tube |
| 868.5730 | Tracheal tube |
| 868.5740 | Tracheal/bronchial differential ventilation tube |
| 868.5750 | Inflatable tracheal tube cuff |
| 868.5800 | Tracheostomy tube and tube off |
| 868.5810 | Airway connector |
| 868.5830 | Autotransfusion apparatus |
| 868.5895 | Continuous ventilator |
| 868.5905 | Noncontinuous ventilator (IPPB) |
| 868.5915 | Manual emergency ventilator |
| 868.5925 | Powered emergency ventilator |
| 868.5935 | External negative pressure ventilator |
| PART 870 -- CARDIOVASCULAR DEVICES | |
| 870.1025 | Arrhythmia detector and alarm |
| 870.1330 | Catheter guide wire |
| 870.1360 | Trace microsphere |
| 870.1750 | External programmable pacemaker pulse generator |
| 870.1800 | Withdrawal-infusion pump |
| 870.3250 | Vascular clip |
| 870.3260 | Vena cava clip |
| 870.3300 | Arterial embolization device |
| 870.3375 | Cardiovascular intravascular filter |
| 870.3450 | Vascular graft prosthesis of less than 6 millimeters diameter |
| 870.3460 | Vascular graft prosthesis of 6 millimeters and greater diameter |
| 870.3470 | Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoro-ethylene |
| 870.3535 | Intra-aortic balloon and control system |
| 870.3545 | Ventricular bypass (assist) device |
| 870.3600 | External pacemaker pulse generator |
| 870.3610 | Implantable pacemaker pulse generator |
| 870.3620 | Pacemaker lead adaptor |
| 870.3650 | Pacemaker polymeric mesh bag |
| 870.3670 | Pacemaker charger |
| 870.3680 | Cardiovascular permanent or temporary pacemaker electrode |
| 870.3700 | Pacemaker programmers |
| 870.3710 | Pacemaker repair or replacement material |
| 870.3800 | Annuloplasty ring |
| 870.3850 | Carotid sinus nerve stimulator |
| 870.3925 | Replacement heart valve |
| 870.4320 | Cardiopulmonary bypass pulsatile flow generator |
| 870.4350 | Cardiopulmonary bypass oxygenator |
| 870.4360 | Nonroller-type cardiopulmonary bypass blood pump |
| 870.4370 | Roller-type cardiopulmonary bypass blood pump |
| 870.5200 | External cardiac compressor |
| 870.5225 | External counter-pulsating device |
| 870.5300 | DC-defibrillator (including paddles) |
| 870.5550 | External transcutaneious cardiac pacemaker (noninvasive) |
| --- | Percutaneous transluminal coronary angioplasty (PTCA) balloon dilation catheter |
| --- | Automatic implanted cardioverter defibrillator system |
| PART 872 -- DENTAL DEVICES | |
| 872.3640 | Endosseous implant |
| PART 874 -- EAR, NOSE, AND THROAT DEVICES | |
| 872.3620 | Ear, nose and throat synthetic polymer material |
| 874.3695 | Mandibular implant facial prosthesis |
| 874.3730 | Laryngeal prosthesis (Taub design) |
| 874.3820 | Emdolmphatic shunt |
| 874.3850 | Endolymphaic shunt tube with valve |
| 874.3930 | Tympanotomy tube with semipermeable membrane |
| --- | Ear, nose, throat natural polymer-collagen material |
| PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES | |
| 876.3350 | Penile inflatable implant |
| 876.5270 | Implanted electrical urinary continence device |
| 876.5540 | A-V shunt cannula |
| 876.5630 | Peritoneal dialysis system and accessories |
| 876.5820 | Hemodialysis system and accessories, dialysate concentrate, hollow fiber capillary dialyzers, disposable dialyzers, high permeability dialyzers, parallel flow dialyzers, single coil dialyzers, twin coil dialyzers, single needle dialysis set, dialysate delivery systems |
| 876.5870 | Sorbent hemoperfusion system |
| 876.5880 | Isolated kidney perfusion and transport system and accessories |
| 876.5955 | Peritoneo-venous shunt |
| 46 FR 7566 (1/23/81) | Urethral sphincter prosthesis |
| 46 FR 7566 (1/23/81) | Urethral replacement |
| PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES | |
| 42 FR 63474 (12/16/77) | Absorbable surgical sutures |
| 42 FR 63474 (12/16/77) | Nonabsorbable surgical sutures |
| 879.4520 | Polytetrafluoroethylene (Teflon) injectable |
| 878.3300 | Surgical mesh |
| 878.3500 | Polytetrafluoroethylene with carbon fibers composite implant material |
| 878.3530 | Inflatable breast prosthesis |
| 878.3540 | Silicone gel-filled breast prosthesis |
| --- | Implanted mammary prosthesis of composite saline and gel-filled design |
| 878.3610 | Esophageal prosthesis |
| 878.3720 | Tracheal prosthesis |
| 878.4300 | Implantable clip |
| 878.4750 | Implantable staple |
| --- | Maxillofacial prosthesis |
| PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES | |
| 880.5130 | Infant radiant warmer |
| 880.5400 | Neonatal incubator |
| 880.5410 | Neonatal transport incubator |
| 880.5725 | Infusion pump |
| --- | Implanted infusion pump |
| PART 882 -- NEUROLOGICAL DEVICES | |
| 882.5030 | Methyl methacrylate for aneurysmorrhaphy |
| 882.5150 | Intravascular occluding catheter |
| 882.5200 | Aneurysm clip |
| 882.5225 | Implanted malleable clip |
| 882.5250 | Burr hole cover |
| 882.5300 | Methyl methacrylate for cranioplasty |
| 882.5320 | Preformed alterable cranioplasty plate |
| 882.5330 | Preformed nonalterable cranioplasty plate |
| 882.5360 | Cranioplasty plate fastener |
| 882.5550 | Central nervous system fluid shunt and components |
| 882.5820 | Implanted cerebellar stimulator |
| 882.5830 | Implanted diaphragmatic/phrenic nerve stimulator |
| 882.5840 | Implanted intracerebral/subcortical stimulator for pain relief |
| 882.5850 | Implanted spinal cord stimulator for bladder evacuation |
| 882.5860 | Implanted neuromuscular stimulator |
| 882.5870 | Implanted peripheral nerve stimulator for pain relief |
| 882.5880 | Implanted spinal cord stimulator for pain relief |
| 882.5880 | Epidural spinal electrode |
| 882.5900 | Preformed craniosynostosis strip |
| 882.5910 | Dura substitute |
| 882.5950 | Artificial embolization device |
| --- | Lyophilized human (cadaver) dura mater |
| --- | Stabilized epidural spinal electrode |
| --- | Implanted intracranial pressure monitor |
| --- | Totally implanted spinal cord stimulator for pain relief |
| PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES | |
| 884.5360 | Contraceptive intrauterine device (IUD) and introducer |
| 884.5380 | Contraceptive tubal occlusion device (TOD) and introducer |
| PART 886 -- OPHTHALMIC DEVICES | |
| 886.3300 | Absorbable implant (scleral buckling method) |
| 886.3400 | Keratoprosthesis |
| 886.3600 | Intraocular lens |
| 886.3920 | Eye valve implant |
| PART 888 -- ORTHOPEDIC DEVICES | |
| 888.3000 | Bone Cap |
| 888.3010 | Bone fixation cerclage |
| 888.3020 | Intramedullary fixation rod |
| 888.3025 | Passive tendon prosthesis |
| 888.3027 | Polymethyllmethaccrylate (PMMA) bone cement |
| 888.3030 | Single/multiple component metallic bone fixation appliance and accessories |
| 888.3040 | Smooth or threaded metallic bone fixation fastener |
| 888.3050 | Spinal interlaminal fixation orthosis |
| 888.3060 | Spinal intervertebral body fixation orthosis |
| 888.3100 | Ankle joint metal/composite semi-constrained cemented prosthesis |
| 888.3110 | Ankle joint metal/polymer semiconstrained cemented prosthesis |
| 888.3120 | Ankle joint metal/polymer non-constrained cemented prosthesis |
| 888.3150 | Elbow joint metal/metal or metal/polymer constrained cemented prosthesis |
| 888.3160 | Elbow joint metal/polymer semi-constrained cemented prosthesis |
| 888.3170 | Elbow joint radial (hemi-elbow) polymer prosthesis |
| 888.3180 | Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis |
| 888.3200 | Finger joint metal/metal constrained uncemented prothesis |
| 888.3210 | Finger joint metal/metal constrained cemented prosthesis |
| 888.3220 | Finger joint metal/polymer constrained cemented prosthesis |
| 888.3230 | Finger joint polymer constrained prosthesis |
| 888.3300 | Hip joint metal constrained cemented or uncemented prosthesis |
| 888.3310 | Hip joint metal/polymer constrained cemented or uncemented prosthesis |
| 888.3320 | Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis |
| 888.3330 | Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis |
| 888.3340 | Hip joint metal/composite semi-constrained cemented prosthesis |
| 888.3350 | Hip joint metal/polymer semi-constrained cemented prosthesis |
| 888.3360 | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis |
| 888.3370 | Hip joint (hemi-hip) acetabular metal cemented prosthesis |
| 888.3380 | Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis |
| 888.3390 | Hip joint femoral (hemi-hip metal/polymer cemented or uncemented prosthesis |
| 888.3400 | Hip joint femoral (hemi-hip) metallic resurfacing prosthesis |
| 888.3410 | Hip joint metal/polymer semi-constrained resurfacing cemented prosthesis |
| 888.3480 | Knee joint femorotibial metallic constrained cemented prosthesis |
| 888.3490 | Knee joint femorotibial metal/composite non-constrained cemented prosthesis |
| 888.3500 | Knee joint femorotibial metal/composite semi-constrained cemented prosthesis |
| 888.3510 | Knee joint femorotibial metal/polymer constrained cemented prosthesis |
| 888.3520 | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis |
| 888.3530 | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis |
| 888.3540 | Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis |
| 888.3550 | Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis |
| 888.3560 | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| 888.3570 | Knee joint femoral (hemi-knee) metallic uncemented prosthesis |
| 888.3580 | Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis |
| 888.3590 | Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis |
| 888.3640 | Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis |
| 888.3650 | Shoulder joint metal/polymer non-constrained cemented prosthesis |
| 888.3660 | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| 888.3680 | Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis |
| 888.3690 | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis |
| 888.3720 | Toe joint polymer constrained prosthesis |
| 888.3730 | Toe joint phalangeal (hemi-toe) polymer prosthesis |
| 888.3750 | Wrist joint carpal lunate polymer prosthesis |
| 888.3760 | Wrist joint carpal scaphoid polymer prosthesis |
| 888.3770 | Wrist joint carpal trapezium polymer prosthesis |
| 888.3780 | Wrist joint polymer constrained prosthesis |
| 888.3790 | Wrist joint metal constrained cemented prosthesis |
| 888.3800 | Wrist joint metal/polymer semi-constrained cemented prosthesis |
| 888.3810 | Wrist joint ulna (hemi-wrist) polymer prosthesis |