KNEE AID
FDA 510(k) clearance K760002 · decided 1976-07-26
Clearance details
- K-number
- K760002
- Device name
- KNEE AID
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-05-26
- Decision date
- 1976-07-26
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- IQI
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- 1831 Olive St. St. Louis, MO, 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 |
|---|---|---|
| Neurosplint (K143458) | Neurospectrum, LLC | 2015-08-13 |
| SENSOR WALK (K052771) | Otto Bock Healthcare LP | 2006-05-03 |
| SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (K031576) | Surgitech, Inc. | 2003-07-31 |
| ACCUFLEX DYNAMIC ELBOW ORTHOSIS (K926391) | Regulatory & Marketing Services, Inc. | 1993-07-22 |
| MCCONNELL SHOULDER BRACE (K910974) | Mcconnell Orthopedic | 1991-03-21 |
| GAIT-AID ORTHOPEDIC INSOLE (K874502) | Gait-Aid, Inc. | 1987-11-30 |
| ADJUSTABLE POLYCENTRIC ELBOW HINGE (K831542) | Fred Sammons, Inc. | 1983-06-24 |
| DROP FOOT BRACE (K831615) | Edward Dilauro, Jr. | 1983-06-15 |
| VARIOUS SUPPORTS AND SPLINTS (K823812) | Danek Medical, Inc. | 1983-01-14 |
| BRACE-UP ALL PURPOSE WRIST BAND (K823113) | Arco Matic, Inc. | 1982-11-16 |
| ROTATION BOOT (K823160) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| BRACE-UP STOCKING KNEE BRACE (K823114) | Arco Matic, Inc. | 1982-11-05 |
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 |