510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K943054Substantially Equivalent

Osteonics Secure-Fit Ad Acetabular Component System

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

K943054 is the FDA 510(k) clearance record for OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM, a class II device, cleared for Osteonics Corp. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 178 510(k) clearances for Osteonics Corp., from to . As of , FDA records show no recalls naming K943054.

Clearance record

Decision date
Received
(99 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Osteonics Corp. 59 Rte. 17, Allendale NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LPH

Trailing 12 months
9 clearances under product code LPH in the twelve months to November 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260
November 20260