510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K862837Substantially Equivalent for Some Indications

Omnifit Total Knee Prosthesis System

Osteonics Corp., Allendale NJ / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K862837 is the FDA 510(k) clearance record for OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM, a class II device, cleared for Osteonics Corp. on under FDA product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer). FDA records list 178 510(k) clearances for Osteonics Corp., from to . As of , FDA records show no recalls naming K862837.

Clearance record

Decision date
Received
(150 days to decision)
Product code
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3520
Device class
Class II
Review panel
Orthopedic
Applicant
Osteonics Corp. 59 Rte. 17, Allendale NJ
Third party review
No

Clearances, product code HSX

Trailing 12 months
2 clearances under product code HSX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HSX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260