DeviceClearance

OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM— 510(k) K863668

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K863668 for OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM, Substantially Equivalent for Some Indications on 1986-12-19. Applicant: Osteonics Corp.. Device class: 2.

Clearance details

Applicant
Osteonics Corp.
Product code
Code JWH
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Allendale, NJ, US
Download summary PDFView on FDA.gov ↗

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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, 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 K863668

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K863668.

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