ZIMMER SEGMENTAL SYSTEM
FDA 510(k) clearance K070978 · decided 2007-07-03
Clearance details
- K-number
- K070978
- Device name
- ZIMMER SEGMENTAL SYSTEM
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-06
- Decision date
- 2007-07-03
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KRO
- Device class
- 2
- Regulation number
- 888.3510
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and accessories- recall (Z-2566-2017) | Zimmer Biomet, Inc. | 2017-03-20 |
| Segmental fluted stem, 18x250mm bwd, Sterile, recall (Z-2574-2017) | Zimmer Biomet, Inc. | 2017-03-20 |
| Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessorie recall (Z-2575-2017) | Zimmer Biomet, Inc. | 2017-03-20 |
| Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bo recall (Z-0783-2014) | Zimmer, Inc. | 2014-01-17 |
| Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement. recall (Z-0784-2014) | Zimmer, Inc. | 2014-01-17 |
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 |