Bibliography:

 

1.   Zdeblick TA, Phillips FM. 

      Interbody cage devices.

      Spine. 2003 Aug 1;28(15):S2-7

 

2.   Christensen FB, Hansen ES, Eiskjaer SP, Hoy K, Helmig P, Neumann P, Niedermann B, Bunger CE. 
Circumferential lumbar spinal fusion with Brantigan cage versus posterolateral fusion with titanium Cotrel-Dubousset instrumentation: a prospective, randomized clinical study of 146 patients.
Spine. 2002 Dec 1;27(23):2674-83. 
 
3.   Hodges SD, Humphreys SC, Eck JC, Murphy RB. 
Intraoperative loosening of Bagby and Kuslich cages during anterior lumbar interbody fusion.
J Spinal Disord. 2000 Dec;13(6):535-7. 
 
4.   Hacker RJ, Cauthen JC, Gilbert TJ, Griffith SL. 
A prospective randomized multicenter clinical evaluation of an anterior cervical fusion cage.
Spine. 2000 Oct 15;25(20):2646-54; discussion 2655. 
 
5.   Kuslich SD, Danielson G, Dowdle JD, Sherman J, Fredrickson B, Yuan H, Griffith SL. 
Four-year follow-up results of lumbar spine arthrodesis using the Bagby and Kuslich lumbar fusion cage.
Spine. 2000 Oct 15;25(20):2656-62. 
 
6.   Brantigan JW, Steffee AD, Lewis ML, Quinn LM, Persenaire JM. 
Lumbar interbody fusion using the Brantigan I/F cage for posterior lumbar interbody fusion and the variable pedicle screw placement system: two-year results from a Food and Drug Administration investigational device exemption clinical trial.
Spine. 2000 Jun 1;25(11):1437-46. 
 
7.   Agazzi S, Reverdin A, May D. 
Posterior lumbar interbody fusion with cages: an independent review of 71 cases.
J Neurosurg. 1999 Oct;91(2 Suppl):186-92. 
 
8.   Kuslich SD, Ulstrom CL, Griffith SL, Ahern JW, Dowdle JD. 
The Bagby and Kuslich method of lumbar interbody fusion.  History, techniques, and 2-year follow-up results of a United States prospective, multicenter trial.
Spine. 1998 Jun 1;23(11):1267-78; discussion 1279. 
 
9.   Ray CD. 
      Threaded titanium cages for lumbar interbody fusions.
Spine. 1997 Mar 15;22(6):667-79; discussion 679-80. 

 


Special ControlsConsensus Standards:

 

1.       ASTM F-136-02:  Standard Specification for Wrought Titanium-6Alumnium-4Vanadium ELI Alloy for Surgical Implant Applications

www.astm.org

 

2.       ASTM F-2026-02 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

www.astm.org

 

3.       F2077-03 Test Methods For Intervertebral Body Fusion Devices

www.astm.org

 

 

FDA Guidances

 

1.       FDA Guidance Document for the Preparation of IDEs for Spinal Systems (note:  example of  type  of document currently used in the preparation of IDEs for intervertebral body fusion devices)     

http://www.fda.gov/cdrh/ode/87.pdf

 

2.   Guidance for Spinal System 510ks (note:  example of type  of document that could be used in  the preparation of 510ks for intervertebral body fusion devices)

http://www.fda.gov/cdrh/ode/guidance/636.pdf