EVOLUTION MP TOTAL KNEE SYSTEM— 510(k) K102380
Substantially EquivalentWrightmedicaltechnologyinc
FDA 510(k) clearance K102380 for EVOLUTION MP TOTAL KNEE SYSTEM, Substantially Equivalent on 2011-01-07. 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
- Special
- 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 K102380
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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102380.
Data sourced from openFDA. This site is unofficial and independent of the FDA.