Panels › Orthopedic › Product code KWT · Class 2
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Regulation 888.3650
2510(k)s in 12 months (72 all time)
0recalls in 12 months (31 all time)
28recalls that name a 510(k)
Top companies in KWT
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer | 8 | 16 |
| Biomet, Inc. | 11 | 4 |
| Exactech, Inc. | 4 | 5 |
| Catalyst Orthoscience, Inc. | 5 | 0 |
| Intermedics Orthopedics | 5 | 0 |
| Zimmer Biomet, Inc. | 0 | 5 |
| Kirschner Medical Corp. | 4 | 0 |
| Biomet Orthopedics | 3 | 0 |
| Depuy, Inc. | 3 | 0 |
| Implantcast GmbH | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 1996 | K960424 | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD Endotec, Inc. | KWT |
| Aug 9, 1996 | K962244 | SELECT SHOULDER PEGGED ALL-POLY GLENOID Intermedics Orthopedics | KWT |
| Aug 9, 1996 | K962238 | SELECT SHOULDER KEELED ALL-POLY GLENOIDS Intermedics Orthopedics | KWT |
| Aug 5, 1996 | K961571 | COCR BI-ANGULAR HUMERAL COMPONENT Biomet, Inc. | KWT |
| Aug 29, 1995 | K940537 | KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM Kirschner Medical Corp. | KWT |
| Oct 14, 1994 | K925613 | PROXIMAL HUMERAL REPLACEMENT SYSTEM Biomet, Inc. | KWT |
| May 9, 1994 | K931114 | SELECT(R) SHOULDER ALL-POLY GLENOID Intermedics Orthopedics | KWT |
| Dec 10, 1992 | K922865 | NEER TYPE SHOULDER PROSTHESIS SYSTEM Osteo Technology, Inc. | KWT |
| Mar 11, 1992 | K915596 | BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD Biomet, Inc. | KWT |
| Jan 16, 1992 | K914695 | GLOBAL TOTAL SHOULDER Depuy, Inc. | KWT |
| Dec 4, 1991 | K914000 | GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE Depuy, Inc. | KWT |
| Mar 26, 1991 | K905786 | GLOBAL TOTAL SHOULDER Depuy, Inc. | KWT |
| Dec 27, 1989 | K895802 | NON CONSTRAINED TOTAL SHOULDER SYSTEM Orthopaedic Medical Group, Inc. | KWT |
| Oct 15, 1987 | K873621 | NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS Kirschner Medical Corp. | KWT |
| Oct 15, 1987 | K873620 | NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE. Kirschner Medical Corp. | KWT |
| Oct 15, 1987 | K873104 | NEER-III GLENOID RESURFACING PROSTHESIS Kirschner Medical Corp. | KWT |
| Aug 27, 1987 | K872454 | BIOMET MODULAR SHOULDER PROSTHESIS Biomet, Inc. | KWT |
| Nov 7, 1983 | K833409 | MONOSPHERICAL RESURFACING GLENOID PROS Howmedica Corp. | KWT |
| Jun 3, 1983 | K831233 | GLENOID RESURFACING COMPONENT-3M-10816 3M Company | KWT |
| Jun 2, 1983 | K831234 | GLENOID RESURFACE COMPONENT PMN 3M 3M Company | KWT |
| Dec 1, 1980 | K802124 | GRISTINA GLENOID PROSTHESIS Howmedica Corp. | KWT |
| Jun 22, 1979 | K790987 | ZIMMER R TOTAL SHOULDER II Zimmer, Inc. | KWT |
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