Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Ardaugh BM, Graves SE, Redberg RF. The 510(k) ancestry of a metal-on-metal hip implant. N Engl J Med 2013;368:97-100. DOI: 10.1056/NEJMp1211581
Table of Contents Predicate device information... 2-5 1 of 5
Each number below represents a corresponding number in the Figure. This list contains the names, companies, 510(k) numbers, and decision dates for most devices. All 510(k) numbers below were explicitly stated in FDA documents. 1. ASR XL Acetabular Cup System (DePuy Orthopaedics, Inc., Warsaw, IN). K080991; 7/2/2008* 2. ASR Acetabular Cup System (DePuy Orthopaedics, Inc., Warsaw, IN). K040627; 8/5/2005 3. Pinnacle Metal-On-Metal Acetabular Cup Liners (DePuy Orthopaedics, Inc., Warsaw, IN). K002883; 10/13/2000 4. Ultima Metal-On-Metal Acetabular Cup (DePuy Orthopaedics, Inc., Warsaw, IN). K001523; 8/10/2000 5. ZTT I and II Acetabular Cup of the S-ROM Total Hip System (Joint Medical Products Corp., Stamford, CT). K951000; 4/14/1995 6. Inter-Op Metasul Acetabular System (Sulzer Orthopedics, Inc., Austin, TX). K974728; 8/3/1999 7. McKee-Farrar Hip System (preamendment device) HIGH RATE OF REVISION; NO LONGER IN USE 8. Ring Hip System (preamendment device) HIGH RATE OF REVISION; NO LONGER IN USE 9. PCA Total Hip System -- Cementless Use (Pfizer Hospital Products Group, Inc., Rutherford, NJ). K920831; 6/10/1992 10. Gripper II Acetabular Cup (Joint Medical Products Corp., Stamford, CT). K893584; 7/28/1989 11. Sivash Hip System (preamendment device) HIGH RATE OF REVISION; NO LONGER IN USE 12. Pinnacle Metal-On-Metal Acetabular Cup Liners (DePuy Orthopaedics, Inc., Warsaw, IN). K003523; 12/13/2000 13. Inter-Op Durasul Acetabular Inserts and CoCr Femoral Heads (Sulzer Orthopedics, Inc., Austin, TX). K993259; 3/10/2000 14. Inter-Op Acetabular System -- Durasul Acetabular Insert (Sulzer Orthopedics, Inc., Austin, TX). K983509; 2/3/1999 15. RIM Flare Acetabular Component (Intermedics Orthopedics, Inc., Austin, TX). K955033; 1/31/1996 16. Whiteside Total Hip System (Dow Corning Wright) 17. Profile Total Hip System (DePuy) 18. Perfecta Total Hip System (Orthomet) 19. CLS Acetabular Component (Protek) 20. RM Isoelastic Bevelled Acetabular Cup (Robert Mathys Co., Malvern, PA). K903116; 10/23/1990 21. Vitalock 22mm Acetabular Shell and System 12 Inserts (Howmedica Corp., Rutherford, NJ). K951115; 6/16/1995 22. Consensus Total Hip System (U.S. Medical Products, Inc., Austin, TX). K922561; 7/21/1993 23. Metal Transcend Articulation System -- Larger Sizes (Wright Medical Technology, Inc., Arlington, TN). K021349; 7/1/2002 2 of 5
24. Metal Transcend Articulation System (Wright Medical Technology, Inc., Arlington, TN). K004043; 7/13/2001. The three predicate devices cited for this device include only other 510(k)s reviewed by the FDA for substantial equivalence and may not be the same as those cited directly by the sponsor. In K004043, device 25 was given a 510(k) number of K993438, but apparently erroneously named FMP Metal/Metal Acetabular Insert (Encore Orthopedics). We assumed the correct predicate device was K993438. 25. Metal-On-Metal Acetabular System (Biomet, Inc., Warsaw, IN). K993438; 5/18/2000 26. Universal Acetabular Cup (Biomet) 27. ASR 300 Acetabular Cup System (DePuy Orthopaedics, Inc., Warsaw, IN). K073413; 1/30/2008 28. Pinnacle Acetabular System (DePuy Orthopaedics, Inc., Warsaw, IN). K000306; 3/23/2000 29. Summit Acetabular System (Johnson & Johnson Professionals, Inc., Raynham, MA). K983014; 10/27/1998 30. Arthopor I and II Acetabular Cup/Arthopor II Oblong Acetabular Cup (Joint Medical Products Corp., Raynham, MA). K955511; 2/26/1996 31. Arthopor Acetabular Component (Joint Medical Products Corp., Stamford, CT). K844050; 12/6/1985 32. S-ROM Oblong Acetabular Cup (Joint Medical Products Corp., Stamford, CT). K905258; 5/21/1991 33. Poly-Dial Inserts (Joint Medical Products Corp., Stamford, CT). K924492; 11/24/1992 34. S-ROM Acetabular Cup -- Part of S-ROM 135 Total Hip System (Joint Medical Products Corp., Stamford, CT). K851421; 6/4/1985 35. S-ROM Poly-Dial Constrained Socket for Acetabular Cup (Joint Medical Products Corp., Washington, DC). K870271; 4/20/1987 36. P.F.C. Total Hip System Porous Coated Modular Acetabular Component (Johnson & Johnson Orthopaedics, Inc., Raynham, MA). K931189; 2/9/1994 37. Bias Acetabular Component (Zimmer) 38. Porous Coated Acetabular Cup (Johnson & Johnson Professionals, Inc., Raynham, MA). K873585; 10/28/1987 39. Duraloc Cementless Acetabular Cup System (DePuy, Inc., Warsaw, IN). K951301; 4/18/1995 40. AML Porocoat Acetabular Cup (DePuy, Inc.). P880025. The PMA database indicates that this product was down-classified to a Class II device. 41. P.F.C. Total Hip System Porous Coated Modular Acetabular Component (Johnson & Johnson Orthopaedics, Inc., Raynham, MA). K930712; 10/4/1993 42. Duraloc Acetabular Cup System (DePuy, Inc., Warsaw, IN). K972596; 11/12/1997 43. Modified Acetabular Cup System (DePuy, Inc., Warsaw, IN). K900832; 5/4/1990 44. Modified AML+ Acetabular Cup (DePuy, Inc., Warsaw, IN). K900891; 3/12/1990 45. Duraloc Cementless Acetabular Cup System (DePuy, Inc., Warsaw, IN). K961186; 9/17/1996 46. Duraloc Cementless Acetabular Cup System (DePuy) 47. Porocoat Lunceford Acetabulum (DePuy, Inc., Warsaw, IN). K823145; 2/9/1983 3 of 5
48. Sbarbaro Acetabulum (Zimmer) 49. Urist Hip Socket (Howmedica) 50. McBride Acetabulum Cup (Howmedica) 51. ASR Taper Sleeve Adapter (DePuy Orthopaedics, Inc., Warsaw, IN). K070359; 3/6/2007 52. Corail AMT Hip Prosthesis (DePuy Orthopaedics, Inc., Warsaw, IN). K042992; 2/11/2005 53. S-ROM 135 Femoral Stem and Collar Part of S-ROM Total Hip System (Joint Medical Products Corp., Stamford, CT). K851422; 9/18/1985 54. SRN Total Hip Prosthesis (marketed from 1975-1982 by the United States Surgical Corporation; since 1982, by Joint Medical Products Corporation) (preamendment device) 55. S-ROM Trochanter Screw and Washer and Calcar Replacement Femoral Stem (Joint Medical Products Corp., Stamford, CT). K910664; 4/1/1992 56. Mallory Head Finned Acetabular Cup (Biomet, Inc., Warsaw, IN). K853259; 11/1/1985 57. Co-Cr Femoral Components (Biomet) 58. Ultima Unipolar Head and Adapter Sleeves (Johnson & Johnson Professionals, Inc., Raynham, MA). K965156; 1/24/1997 59. Ultima Unipolar Modular Head (Johnson & Johnson Orthopaedics, Inc., Raynham, MA). K940190; 9/29/1994 60. Modular Unipolar System (Howmedica Corp., Rutherford, NJ). K902365; 1/11/1991 61. Modular Austin Moore Hip (Zimmer) 62. Austin Moore Hip (Howmedica) (preamendment device) 63. Austin Moore Modular Hip Prosthesis (Biomet) * An FDA review memo dated July 1, 2008, from within the full-text 510(k) indicated that the ASR XL was also compared to the Biomet M 2 a Magnum System (K042037), which was cleared in femoral head sizes up to 60 mm without clinical data. However, to be conservative, we did not trace this device or include it in our counts. DePuy also justified the use of the Porocoat porous-coated acetabular cup by citing its AML Hip Prosthesis (P820024) and Solution System Hip Prosthesis (K030979), where the company claimed the porous coating had been fully characterized. P820024 was counted as a predicate for femoral stems in different parts of the ancestry (not shown in Figure), and K030979 was not counted as a predicate device. An FDA review memo dated August 3, 2005, from within the full-text 510(k) indicated that the ASR was also compared to the Biomet M 2 a Acetabular System (K993438, K002379, K003363, K011110, and K042037), which underwent similar changes in sizes, materials, and diametrical clearances, without clinical data. Specifically, this memo read, Based on the changes that have previously been allowed with mechanical testing according to the Biomet description above, the proposed DePuy changes are comparable." To be conservative, we did not trace most of these individual devices or include them in our counts, except for K993438, which was counted as a predicate of device 24. This memo also cited the Corin USA Cormet Large Diameter Metal-On-Metal Hip System (IDE: G030265) 4 of 5
and the Wright Medical Metal Transcend Articulation System (K004043) as devices that may have also supported substantial equivalence. However, to be conservative, we did not include the Cormet hip system in our counts; we counted the Transcend hip system under device 23, where it was clearly cited as a predicate device. Named as a predicate device, but 510(k) number not ascertainable. An FDA review memo for this device, dated February 20, 1996, stated that the porous coating for these acetabular components was the same as that applied by Bio-Vac to the same devices previously cleared for cemented use only. Femoral stem. (Other femoral stems and ceramic heads excluded for clarity.) Not a direct predicate of device 52 but within its ancestry. 5 of 5