510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K933882Substantially Equivalent for Some Indications

Osteonics Ps Hemi-Hip Stem Series

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

K933882 is the FDA 510(k) clearance record for OSTEONICS PS HEMI-HIP STEM SERIES, 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 K933882.

Clearance record

Decision date
Received
(734 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
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