APOLLO(TM) KNEE SYSTEM— 510(k) K925242

Substantially Equivalent for Some Indications

Intermedics Orthopedics

FDA 510(k) clearance K925242 for APOLLO(TM) KNEE SYSTEM, Substantially Equivalent for Some Indications on 1993-06-04. Applicant: Intermedics Orthopedics.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1992-10-16
Decision date: 1993-06-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.