NATURAL-KNEE II SYSTEM
FDA 510(k) clearance K936159 · decided 1995-05-22
Clearance details
- K-number
- K936159
- Device name
- NATURAL-KNEE II SYSTEM
- Applicant
- Intermedics Orthopedics
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1993-12-23
- Decision date
- 1995-05-22
- Days to decision
- 515 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-const recall (Z-0839-2016) | Zimmer Biomet, Inc. | 2016-02-22 |
| Natural-Knee N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 recall (Z-1249-2014) | Zimmer, Inc. | 2014-03-20 |
| Natural-Knee II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB recall (Z-1262-2014) | Zimmer, Inc. | 2014-03-20 |
| Natural-Knee Flex Femoral Component. Provides increased flexion capability. recall (Z-0075-2014) | Zimmer, Inc. | 2013-10-25 |
| Natural-Knee II Femoral Component recall (Z-0078-2014) | Zimmer, Inc. | 2013-10-25 |