510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K896856Substantially Equivalent for Some Indications

Mod-Ml Unicompartmental Knee Prosthesis

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

K896856 is the FDA 510(k) clearance record for MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS, 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 K896856.

Clearance record

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