Supplementary Appendix
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1 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: DOI: /NEJMp
2 Table of Contents Predicate device information of 5
3 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/ Pinnacle Metal-On-Metal Acetabular Cup Liners (DePuy Orthopaedics, Inc., Warsaw, IN). K002883; 10/13/ Ultima Metal-On-Metal Acetabular Cup (DePuy Orthopaedics, Inc., Warsaw, IN). K001523; 8/10/ ZTT I and II Acetabular Cup of the S-ROM Total Hip System (Joint Medical Products Corp., Stamford, CT). K951000; 4/14/ Inter-Op Metasul Acetabular System (Sulzer Orthopedics, Inc., Austin, TX). K974728; 8/3/ 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/ Gripper II Acetabular Cup (Joint Medical Products Corp., Stamford, CT). K893584; 7/28/ 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/ Inter-Op Durasul Acetabular Inserts and CoCr Femoral Heads (Sulzer Orthopedics, Inc., Austin, TX). K993259; 3/10/ Inter-Op Acetabular System -- Durasul Acetabular Insert (Sulzer Orthopedics, Inc., Austin, TX). K983509; 2/3/ RIM Flare Acetabular Component (Intermedics Orthopedics, Inc., Austin, TX). K955033; 1/31/ 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/ Vitalock 22mm Acetabular Shell and System 12 Inserts (Howmedica Corp., Rutherford, NJ). K951115; 6/16/ Consensus Total Hip System (U.S. Medical Products, Inc., Austin, TX). K922561; 7/21/ Metal Transcend Articulation System -- Larger Sizes (Wright Medical Technology, Inc., Arlington, TN). K021349; 7/1/ of 5
4 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 K Metal-On-Metal Acetabular System (Biomet, Inc., Warsaw, IN). K993438; 5/18/ Universal Acetabular Cup (Biomet) 27. ASR 300 Acetabular Cup System (DePuy Orthopaedics, Inc., Warsaw, IN). K073413; 1/30/ Pinnacle Acetabular System (DePuy Orthopaedics, Inc., Warsaw, IN). K000306; 3/23/ Summit Acetabular System (Johnson & Johnson Professionals, Inc., Raynham, MA). K983014; 10/27/ Arthopor I and II Acetabular Cup/Arthopor II Oblong Acetabular Cup (Joint Medical Products Corp., Raynham, MA). K955511; 2/26/ Arthopor Acetabular Component (Joint Medical Products Corp., Stamford, CT). K844050; 12/6/ S-ROM Oblong Acetabular Cup (Joint Medical Products Corp., Stamford, CT). K905258; 5/21/ Poly-Dial Inserts (Joint Medical Products Corp., Stamford, CT). K924492; 11/24/ S-ROM Acetabular Cup -- Part of S-ROM 135 Total Hip System (Joint Medical Products Corp., Stamford, CT). K851421; 6/4/ S-ROM Poly-Dial Constrained Socket for Acetabular Cup (Joint Medical Products Corp., Washington, DC). K870271; 4/20/ P.F.C. Total Hip System Porous Coated Modular Acetabular Component (Johnson & Johnson Orthopaedics, Inc., Raynham, MA). K931189; 2/9/ Bias Acetabular Component (Zimmer) 38. Porous Coated Acetabular Cup (Johnson & Johnson Professionals, Inc., Raynham, MA). K873585; 10/28/ Duraloc Cementless Acetabular Cup System (DePuy, Inc., Warsaw, IN). K951301; 4/18/ AML Porocoat Acetabular Cup (DePuy, Inc.). P 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/ Duraloc Acetabular Cup System (DePuy, Inc., Warsaw, IN). K972596; 11/12/ Modified Acetabular Cup System (DePuy, Inc., Warsaw, IN). K900832; 5/4/ Modified AML+ Acetabular Cup (DePuy, Inc., Warsaw, IN). K900891; 3/12/ Duraloc Cementless Acetabular Cup System (DePuy, Inc., Warsaw, IN). K961186; 9/17/ Duraloc Cementless Acetabular Cup System (DePuy) 47. Porocoat Lunceford Acetabulum (DePuy, Inc., Warsaw, IN). K823145; 2/9/ of 5
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/ Corail AMT Hip Prosthesis (DePuy Orthopaedics, Inc., Warsaw, IN). K042992; 2/11/ S-ROM 135 Femoral Stem and Collar Part of S-ROM Total Hip System (Joint Medical Products Corp., Stamford, CT). K851422; 9/18/ SRN Total Hip Prosthesis (marketed from 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/ Mallory Head Finned Acetabular Cup (Biomet, Inc., Warsaw, IN). K853259; 11/1/ Co-Cr Femoral Components (Biomet) 58. Ultima Unipolar Head and Adapter Sleeves (Johnson & Johnson Professionals, Inc., Raynham, MA). K965156; 1/24/ Ultima Unipolar Modular Head (Johnson & Johnson Orthopaedics, Inc., Raynham, MA). K940190; 9/29/ Modular Unipolar System (Howmedica Corp., Rutherford, NJ). K902365; 1/11/ 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. P was counted as a predicate for femoral stems in different parts of the ancestry (not shown in Figure), and K 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
6 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
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