EVOLUTION MP TOTAL KNEE SYSTEM
FDA 510(k) clearance K093552 · decided 2010-03-04
Clearance details
- K-number
- K093552
- Device name
- EVOLUTION MP TOTAL KNEE SYSTEM
- Applicant
- Wrightmedicaltechnologyinc
- Decision
- Substantially Equivalent
- Date received
- 2009-11-17
- Decision date
- 2010-03-04
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION recall (Z-0699-2025) | MicroPort Orthopedics Inc. | 2024-12-18 |
| EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants recall (Z-2244-2024) | MicroPort Orthopedics Inc. | 2024-07-01 |
| EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base recall (Z-0275-2023) | MicroPort Orthopedics Inc. | 2022-11-22 |
| EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base recall (Z-0276-2023) | MicroPort Orthopedics Inc. | 2022-11-22 |
| EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KE recall (Z-1249-2015) | Microport Orthopedics INC. | 2015-03-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL (P960057/S011) | Wrightmedicaltechnologyinc | 2000-09-27 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S004) | Wrightmedicaltechnologyinc | 1999-08-11 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S008) | Wrightmedicaltechnologyinc | 1999-06-02 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S006) | Wrightmedicaltechnologyinc | 1999-04-21 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S005) | Wrightmedicaltechnologyinc | 1999-03-18 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S003) | Wrightmedicaltechnologyinc | 1999-01-14 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S002) | Wrightmedicaltechnologyinc | 1998-11-25 |
| ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057/S001) | Wrightmedicaltechnologyinc | 1998-09-11 |