TC-PLUS SOLUTION KNEE
FDA 510(k) clearance K000666 · decided 2000-10-13
Clearance details
- K-number
- K000666
- Device name
- TC-PLUS SOLUTION KNEE
- Applicant
- Plus Orthopedics
- Decision
- Substantially Equivalent
- Date received
- 2000-02-28
- Decision date
- 2000-10-13
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8. recall (Z-0126-06) | Plus Orthopedics USA | 2005-11-03 |
| TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456 recall (Z-0013-06) | Plus Orthopedics USA | 2005-10-07 |
| TC-PLUS Tibial Insert 2; 15mm, Model 25309 recall (Z-0014-06) | Plus Orthopedics USA | 2005-10-07 |
| TC-PLUS Tibial Insert UC 4; 11mm, Model 25427 recall (Z-0015-06) | Plus Orthopedics USA | 2005-10-07 |
| TC-PLUS Tibial Insert UC 4; 13mm, Model 25428 recall (Z-0016-06) | Plus Orthopedics USA | 2005-10-07 |
| TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436 recall (Z-0017-06) | Plus Orthopedics USA | 2005-10-07 |
| TC-PLUS Tibial Insert UC 6; 13mm, Model 25438 recall (Z-0018-06) | Plus Orthopedics USA | 2005-10-07 |
| TC-PLUS Tibial Insert UC 10; 11mm, Model 25457 recall (Z-0019-06) | Plus Orthopedics USA | 2005-10-07 |
| TC-PLUS Solution Tibial Component-- Symmetric recall (Z-0017-04) | Plus Endoprothetik AG | 2003-10-15 |