EVOLUTION MP TOTAL KNEE SYSTEM— 510(k) K093552
Substantially EquivalentWrightmedicaltechnologyinc
FDA 510(k) clearance K093552 for EVOLUTION MP TOTAL KNEE SYSTEM, Substantially Equivalent on 2010-03-04. Applicant: Wrightmedicaltechnologyinc. Device class: 2.
Clearance details
- Applicant
- Wrightmedicaltechnologyinc
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, TN, US
Recent devices under product code JWH
view allMore clearances from Wrightmedicaltechnologyinc
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K093552
K-number listed on FDA's recall record- Z-0699-2025 — EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
- Z-2244-2024 — EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
- Z-0275-2023 — EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
- Z-0276-2023 — EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
- Z-1249-2015 — EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093552.
Data sourced from openFDA. This site is unofficial and independent of the FDA.