Panels › Orthopedic › Product code LPH · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation 888.3358
11510(k)s in 12 months (565 all time)
3recalls in 12 months (299 all time)
269recalls that name a 510(k)
Top companies in LPH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 46 | 56 |
| Biomet, Inc. | 44 | 43 |
| DePuy Orthopaedics, Inc. | 33 | 23 |
| Zimmer Biomet | 1 | 48 |
| Howmedica Osteonics | 16 | 31 |
| Exactech, Inc. | 19 | 26 |
| Smith & Nephew, Inc. | 32 | 4 |
| Depuy, Inc. | 24 | 0 |
| Encore Medical L.P. | 13 | 11 |
| Howmedica Corp. | 18 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 1993 | K926201 | OSTEONICS MICROSUTERED FEMORAL COMPONENTES Osteonics Corp. | LPH |
| Apr 2, 1993 | K921400 | HIP JOINT PROTHESIS Smith & Nephew Richards, Inc. | LPH |
| Nov 24, 1992 | K924492 | POLY-DIAL INSERTS Joint Medical Products Corp. | LPH |
| Jul 2, 1992 | K921639 | BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM Zimmer, Inc. | LPH |
| Jun 10, 1992 | K920831 | PCA TOTAL HIP SYSTEM (CEMENTLESS USE) Pfizer Hospital Products Group, Inc. | LPH |
| Jan 22, 1990 | K896637 | ACCESS(TM), SOFTWARE RELEASE 4.11P Diasonics, Inc. | LPH |
| Jul 30, 1986 | K862702 | TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS Depuy, Inc. | LPH |
| Jul 16, 1986 | K862326 | POROUS COATED HIP FEMORAL PROSTHESIS Johnson & Johnson Professionals, Inc. | LPH |
| May 6, 1986 | K860442 | PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259 Howmedica Corp. | LPH |
| Mar 14, 1986 | K860635 | OPTI-FIX TOTAL HIP SYSTEM Richards Medical Co., Inc. | LPH |
| Aug 22, 1985 | K852198 | AML PROXIMAL POROCOAT FEMORAL HIP Depuy, Inc. | LPH |
| Jun 4, 1985 | K851421 | S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP Joint Medical Products Corp. | LPH |
| Mar 27, 1984 | K833681 | POROCOAT HPS II HIP PROSTHESIS Depuy, Inc. | LPH |
| Mar 2, 1984 | K833439 | POROCOAT NEB TOTAL HIP SYSTEM Depuy, Inc. | LPH |
| Jan 27, 1984 | K833464 | POROCOAT SCHATZKER ACETABULUM Depuy, Inc. | LPH |
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