DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
FDA 510(k) clearance K982330 · decided 1998-09-25
Clearance details
- K-number
- K982330
- Device name
- DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-02
- Decision date
- 1998-09-25
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| OviTex PRS (Long Term Resorbable) (K214070) | Tela Bio | 2023-03-21 |
| VersaWrap (K213163) | Alafair Biosciences, Inc. | 2021-10-29 |
| PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K213125) | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021-10-27 |
| Nexo-Gide Bilayer Collagen Membrane (K203496) | Geistlich Pharma AG | 2021-07-14 |
| VersaWrap (K203600) | Alafair Biosciences, Inc. | 2021-03-09 |
| Lyograft (K192452) | B. Bruan Surgical, SA | 2020-09-03 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |