OPTIGEN TOTAL KNEE SYSTEM— 510(k) K102367

Name: FDA 510(k) clearance K102367
Creator: U.S. Food and Drug Administration
Published: 2010-12-08

Substantially Equivalent

U&I Corp.

FDA 510(k) clearance K102367 for OPTIGEN TOTAL KNEE SYSTEM, Substantially Equivalent on 2010-12-08. Applicant: U&I Corp.. Device class: 2.

Clearance details

Applicant: U&I Corp.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2010-08-20
Decision date: 2010-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uijungbu, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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K253961 — SK Knee System2026-09-01

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Adverse 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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.