ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM— 510(k) K093567

Name: FDA 510(k) clearance K093567
Creator: U.S. Food and Drug Administration
Published: 2010-02-05

Substantially Equivalent

Anova Implant Solutions, LLC

FDA 510(k) clearance K093567 for ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM, Substantially Equivalent on 2010-02-05. Applicant: Anova Implant Solutions, LLC. Device class: 2.

Clearance details

Applicant: Anova Implant Solutions, LLC
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2009-11-18
Decision date: 2010-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brentwood, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

view all

K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

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.