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
K896853Substantially Equivalent for Some Indications

Precision Osteolock Femoral Comp. Titanium Plasma

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

K896853 is the FDA 510(k) clearance record for PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA, a class II device, cleared for Howmedica Corp. on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K896853.

Clearance record

Decision date
Received
(148 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Howmedica Corp. 359 Veterans Blvd., Rutherford NJ
Third party review
No

Clearances, product code KWL

Trailing 12 months
3 clearances under product code KWL 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 KWL, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260