2005P-0121
CCP 1
Volume 1, 2

Volume 1

Cover Letter

Table of Contents

Citizen Petition

Attachment 1 - Proposed FDA Guidance Document Entitled "Class II Special Controls Guidance Document: Contents of Premarket Notifications [510(k)s] for Non-invasive Bone Growth Stimulators"

Attachment 2 - Supplemental Data Sheet for the Non-invasive Bone Growth Stimulator

Attachment 3 - Classification Questionnaire for the Non-invasive Bone Growth StimuIator

Attachment 4 - Literature Search Strategy and Results

Attachment 5 - Bibliography of the Benefits of the Non-invasive Bone Growth Stimulator for Nonunions and Delayed Unions

Tab 1 - Abeed, R. I.; Naseer, M., and Abel, E. W. Capacitively coupled electrical stimnlation treatment: results from patients with failed long bone fracture unions. J Orthop Trauma. 1998 Sep-1998 Oct 31; 12 (7): 510-513.

Tab 2 - Adams, B. D.; Frykman, G. K., and Taleisnik, J. Treatment of scaphoid nonunion with casting and pulsed electromagnetic fields: a study continuation. J. Hand Surg [Am], 1992 Sep; 17 (5): 910-914.

Tab 3 - Bassett, C. A.; Mitchell, S. N., and Gaston, S. R. Pulsing electromagnetic field treatment in ununited fractures and failed arthrodeses. JAMA. 1982 Feb 5; 247 (5): 623-628.

Tab 4 - Bassett, C. A.; Mitchell, S. N., and Schink, M. M. Treatment of therapeutically resistant non-unions with bone grafts and pulsing electromagnetic fields. J Bone Joint Surg Am. 1982 Oct; 64 (8): 1214-1220.

Tab 5 - Bassett, C. A.; Pilla, A. A., and Pawluk, R. J. A non-operative salvage of surgically-resistant pseudarthroses and non-unions by pulsing electromagnetic fields. A preliminary report. Clin Orthop. 1977 May; 124: 128-143.

Tab 6 - Bassett, C. A,; Mitchell, S. N.; Norton, L., and Pilla, A. Repair of non-unions by pulsing electromagnetic fields. Acta Orthop Belg. 1978 Sep-1978 Oct 31; 44 (5): 706-724.

Tab 7 - Bassett, C.A. Treatment of ununited tibial diaphyseal fractures with pulsing electromagnetic fields. J Bone Joint Surg Am. 1981 Apr; 63 (4): 511-523.

Tab 8 - Benazzo, F.; Mosconi, M.; Beccarisi, G., and Galli, U. Use of capacitive coupled electric fields in stress fractures in athletes. Clin Orthop. 1995 Jan; 310: 145-149.

Tab 9 - Brighton, C. T. and Pollack, S. R. Treatment of recalcitrant non-union with a capacitively coupled electrical field. A preliminary report. J Bone Joint Surg Am. 1985 Apr; 67 (4): 577-585.

Tab 10 - Brighton, C. T.; Shaman, P.; Heppenstall, R. B.; Esterhai, J. L. Jr; Pollack, S. R., and Friedenberg, Z. B. Tibial nonunion treated with direct current, capacitive coupling, or bone graft. Clin Orthop. 1995 Dec; 321: 223-234.

Tab 11 - Caullay, J. M. and Mann, T. S. Pulsing electromagnetic fields in the treatment of non-union of fractures. J R Coll Surg Edinb. 1982 Mar; 27 (2): 102-107.

Tab 12 - Cheng, N.; Van Hoof, H.; Delport, P. H.; Hoogmartens, M. J., and MuIier, J. C. Treatment of non-union, congenital pseudarthroses and benign cystic lesions using pulsed electromagnetic fields. Reconstr Surg
Traumatol. 1985; 19: 118-122.

Tab 13 - Colson, D. J.; Browett, J. P.; Fiddian, N. J., and Watson, B. Treatment of delayed- and non-union of fractures using pulsed electromagnetic fields. J Biomed Eng. 1988 Jul; 10 (4): 301-314.

Tab 14 - Delima, D. F. and Tanna, D. D. Role of pulsed electromagnetic fields in recalciuant non-unions. J Postgrad Med. 1989 Jan; 35 (1): 43-48.

Tab 15 - Dhawan, S. K.; Conti, S. F.; Towers, J.; Abidi, N. A., and Vogt, M. The effect of pulsed electromagnetic fields on hindfoot arthrodesis: a prospective study. J Foot Ankle Surg. 2004 Mar-2004 Apr 30; 43 (2): 93-96.

Tab 16 - Fontanesi, G.; Giancecchi, F.; Rotini, R., and Cadossi, R. Treatment of delayed union and pseudarthrosis by low frequency pulsing electromagnetic stimulation. Study of 35 cases. Ital J Orthop Traumatol. 1983 Sep; 9 (3): 305-318.

Tab 17 - Frykman, G. K.; Taleisnik, J.; Peters, 6.; Kaufman, R.; Helal, B.; Wood, V. E., and Unsell, R. S. Treatment of nonunited scaphoid fractures by pulsed electromagnetic field and cast. J Hand Surg [Am]. 1986 May; 11 (3): 344-349.

Tab 18 - Garland, D.E.; Moses, B., and Salyer, W. Long-term follow-up of fracture nonunions treated with PEMFs. Cont Orthop. 1991, Mar; 22 (3): 295-302.

Tab 19 - Gossling, H. R.; Bernstein, R. A., and Abbott, J. Treatment of ununited tibial fractures: a comparison of
surgery and pulsed electromagnetic fields (PEMF). Orthopedics. 1992 Jun; 15 (6): 711-719.

Tab 20 - Heckman, J. D.; Ingram, A. J.; Loyd, R. D.; Luck, J. V. Jr, and Mayer, P. W. Nonunion treatment with pulsed electromagnetic fields. Clin Orthop. 1981 Nov-1981 Dec 31; 161: 58-66.

Tab 21 - Hinsenkamp, M.; Ryaby, J., and Burny, F. Treatment of non-union by pulsing electromagnetic field: European multicenter study of 308 cases. Reconstr Surg Traumatol. 1985; 19: 147-151.

Tab 22 - Holmes, G. B. Jr. Treatment of delayed unions and nonunions of the proximal fifth metatarsal with pulsed electromagnetic fields. Foot Ankle Int, 1994 Oct; 15 (10): 552-556.

Tab 23 - Ito, H. and Shirai, Y. The efficacy of ununited tibial fracture treatment using pulsing electromagnetic fields: relation to biological activity on nonunion bone ends. J Nippon Med Sch. 2001 Apr; 68 (2): 149-153.

Tab 24 - Madronero, A.; Pitillas, I., and Manso, F. J Pulsed electromagnetic field treatment failure in radius non-united fracture healing. J Biomed Eng. 1988 Oct; 10 (5): 463-466.

Tab 25 - Marcer, M.; Musatti, G., and Bassett, C. A. Results of pulsed electromagnetic fields (PEMFs) in ununited fractures after external skeletal fixation. Clin Orthop. 1984 Nov; 190: 260-245.

Tab 26 - Meskens, M. W.; Stuyck, J. A.; Feys, H., and Mulier, J. C. Treatment of nonunion.uslng pulsed electromagnetic fields: a retrospective follow-up study. Acta Orthop Belg. 1990; 56 (2): 483-488.

Tab 27 - Meskens, M. W.; Stuyck, J. A., and Mulier, J. C. Treatment of delayed union and nonunion of the tibia by pulsed electromagnetic fields. A retrospective follow-up. Bull Hosp Jt Dis Orthop Inst. 1988 Fall; 48 (2):
170-175.

Tab 28 - O’Connor, B. T. Treatment of surgically resistant non-unions with pulsed electomagnetic fields. Reconstr Surg Traumatol. 1985; 19: 123-132.

Tab 29 - Scott, G. and King, J. B. A prospective, double-blind trial of electrical capacitive coupling in the treatment of non-union of long bones. J Bone Joint Surg Am. 1994 Jun; 76 (6): 820-826.

Tab 30 - Sedel, L.; Christel, P.; Duriez, J.; Duriez, R.; Evrard, J.; Ficat, C.; Cauchoix, J., and Witvoet, J. Results of non unions treatment by pulsed electromagnetic field stimulation. Acta Orthop Stand Suppl. 1982; 196: 81-91.

Tab 31 - Sharrard, W. J. A double-blind trial of pulsed electromagnetic fiilds for delayed union of tibial fractures. J Bone Joint Surg Br. 1990 May; 72 (3): 347-355.

Tab 32 - Sharrard, W. J.; Sutcliffe, M. L.; Robson, M. J., and Maceachern, A. G. The treatment of fibrous non-union of fractures by pulsing electromagnetic stimulation. J Bone Joint Surg Br. 1982; 44 (2): 189-193.

Tab 33 - Simonis, R.. B.; Good, C., and Cowell, T. K. The treatment of non-union by putsed electromagnetic fields combined with a Denham external fixator. Injury. 1984 Jan; 13 (4): 255-260.

Volume 2

Attachment 6 - Bibliography for the Benefits of the Non-invasive Bone Growth Stimulator as an Adjunct for Spinal Fusion

Tab 1 - Bose, B. Outcomes after posterolateral lumbar fusion with instrumentation in patients treated with adjunctive pulsed electromagnetic field stimulation. Adv Ther. 2001 Jan-2001 Feb 28; 18 (1): 12-20.

Tab 2 - Di Silvestre, M. and Savini, R. Pulsing electromagnetic fields (PEMFs) in spinal fusion: preliminary clinical results. Chir Organi Mov. 1992 Jul-1992 Sep 30; 77 (3): 289-294.

Tab 3 - Goodwin, C. B.; Brighton, C. T.; Guyer, R. D.; Johnson, J. R.; Light, K. I., and Yuan, H. A. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine. 1999 Jul 1; 24 (13): 1349-1356; discussion 1357.

Tab 4 - Jenis, L. G.; An, H. S.; Stein, R., and Young, B. Prospective comparison of the effect of direct current electrical stimulation and pulsed electromagnetic fields on instrumented posterolateral lumbar arthrodesis. J Spinal Disord. 2000 Aug; 13 (4): 290-296.

Tab 5 - Linovitz, R. J.; Pathria, M.; Bemhardt, M.; Green, D.; Law, M. D.; McGuire, R. A.; Montesano, P. X.; Rechtine, G.; Salib, R. M.; Ryaby, J. T.; Faden, J. S.; Ponder, R.; Muenz, L. R.; Magee, F. P., and Garfin, S. A. Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study. Spine. 2002 Jul 1; 27 (13): 1383-1388; discussion 1389.

Tab 6 - Marks, R. A. Spine fusion for discogenic low back pain: outcomes in patients treated with or without pulsed electromagnetic field stimulation. Adv Ther. 2000 Mar-2000 Apr 30; 17 (2): 57-67.

Tab 7 - Mooney, V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. Spine. 1990 Jul; 15 (7): 708-712.

Tab 8 - Simmons, J. W. Treatment of failed posterior lumbar interbody fusion (PLIF) of the spine with pulsing electromagnetic fields. Clin Orthop. 1985 Mar; 193: 127-132.

Tab 9 - Simmons, J. W. Jr; Mooney, V., and Thacker, 1. Pseudarthrosis after lumbar spine fusion: nonoperative salvage with pulsed electromagnetic fields. Am J Orthop. 2004 Jan; 33 (1): 27-30.

Attachment 7 - Safety Information on the Non-invasive Bone Growth Stimulator from the Medical Device Reports Databases

Attachment 8 - Bibliography of the Additional Citations Regarding the Commercially Available Non-invasive Bone Growth Stimulators

Tab 1 - Bassett, C.A.L. Augmentation of bone repair by inductively coupled electromagnetic fields. Science. 1974 May; 575-577.

Tab 2 - Bassett, C.A.L. Generation of electrical potentials by bone in response to mechanical stress. Science. 1962 Sep; 18; 137: 1063-1064.

Tab 3 - Bassett, C.A.L. Non-invasive methods for stimulating osteogenesis. J. Biomed. Mat. Res. 1975; 9: 371-374.

Tab 4 - Bassett, C.A.L. Pulsing Electromagnetic Fields: A new approach to surgical problems. In Metabolic Surgery. Edited by H. Buckwald and R.L. Varco, Grune and Stratton. 1978; 255-306.

Tab 5 - Bassett, C.A.L.; Pawluk, R.J. Acceleration of fracture repair by electromagnetic fields. A surgically noninvasive method. N.Y. Acad. Sci. 1974; 238: 242-262.

Tab 6 - Beckenbaugh, R.D. Noninvasive pulsed electromagnetic stimulation in the treatment of scaphoid nonunion. J Bone Joint Surg Am. 1984; 8(1); 19.

Tab 7 - Beigler, D., et al. Multicenter nonunion clinical investigation of the OL1000 bone growth stimulator. White Paper. 1994.

Tab 8 - Boyd, H.B.; Lipinski, S.W.; Wiley, J.H. Observations on non-union of the shafts of the long bones, with a statistical analysis of 842 patients. J Bone Joint Surg Am. 1961 Mar; 43A (2): 159-168.

Tab 9 - Brighton, C.T., Black, J.; Friedenberg, Z.B.; Esterhai, J.L. A multicenter study of the treatment of non-union with constant direct current. J Bone Joint Surg Am. 1981 Jan; 63A (1): 2-13.

Tab 10 - DeHaas, W.G.; Beaupre, A.; Cameron, H., English, E. The Canadian experience with pulsed electromagnetic fields in the treatment of ununited tibial fractures. Clin Orthop. 1986 July; 208: 55-58.

Tab 11 - Heppenstall, R.B. Fracture Treatment and Healing. W.B. Saunders Co. 1-1069.

Tab 12 - Mueller, M.E.; Thomas, R.J. Treatment of non-union in fractures of long bones. Clin Orthop. 1979 Jan-Feb; 138: 141-153.

Tab 13 - Nelson, F.R.; Brighton, C.T.; Ryaby, J.; Simon, B.J., Nielson, J.H; Lorich, D.G.; Bolander, M. and Seelig, J. Use of Physical Forces in Bone Healing. J Am Acad Orthop Surg. 2003; 11: 344-354.

Tab 14 - ZumBrunnen, J.D., Brindley, H.H. Nonunion of the shafts of the long bones. JAMA. 1968 Feb, 203 (9): 121-124.