VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
FDA 510(k) clearance K073499 · decided 2008-08-07
Clearance details
- K-number
- K073499
- Device name
- VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-13
- Decision date
- 2008-08-07
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- JDL
- Device class
- 3
- Regulation number
- 888.3320
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DYNASTY ACETABULAR SYSTEM (K070785) | Wrightmedicaltechnologyinc | 2007-07-11 |
| DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (K061844) | Wrightmedicaltechnologyinc | 2006-12-06 |
| PROFEMUR RENAISSANCE HIP STEM (K051995) | Wrightmedicaltechnologyinc | 2005-08-22 |
| CONSERVE TOTAL FEMORAL HEAD (K051348) | Wrightmedicaltechnologyinc | 2005-08-19 |
| M2A/C2A ACETABULAR SYSTEM (K042841) | Biomet, Inc. | 2004-12-21 |
| PROFEMUR S HIP STEM (K041586) | Wrightmedicaltechnologyinc | 2004-07-09 |
| PROFEMUR TAPERED HIP STEM (K041114) | Wrightmedicaltechnologyinc | 2004-05-28 |
| METAL TRANSCEND ARTICULATION SYSTEM (K004043) | Wrightmedicaltechnologyinc | 2001-07-13 |
| METAL BACKED ACETABULAR COMPONENT (K950542) | Encore Orthopedics, Inc. | 1995-05-25 |
| P.F.C. APICAL PLUG (K944769) | Johnson & Johnson Professionals, Inc. | 1994-12-08 |
| ACETABULAR DOME HOLE PLUGS (K942809) | Osteonics Corp. | 1994-09-20 |
| S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG (K931676) | Joint Medical Products Corp. | 1994-05-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |