BALANCED KNEE SYSTEM REVISION OFFSET TIBIA— 510(k) K103837

Name: FDA 510(k) clearance K103837
Creator: U.S. Food and Drug Administration
Published: 2011-03-24

Substantially Equivalent

Ortho Development

FDA 510(k) clearance K103837 for BALANCED KNEE SYSTEM REVISION OFFSET TIBIA, Substantially Equivalent on 2011-03-24. Applicant: Ortho Development. Device class: 2.

Clearance details

Applicant: Ortho Development
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2010-12-30
Decision date: 2011-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K262130 — ATTUNE Revision Knee System2026-09-04
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.