510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993768Substantially Equivalent

Citation Tmzf Ha Stem

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

K993768 is the FDA 510(k) clearance record for CITATION TMZF HA STEM, a class II device, cleared for Howmedica Osteonics Corp. on under FDA product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate). FDA records list 377 510(k) clearances for Howmedica Osteonics Corp., from to . As of , FDA records show 12 recalls naming K993768.

Clearance record

Decision date
Received
(74 days to decision)
Product code
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Howmedica Osteonics Corp. 359 Veterans Blvd., Rutherford NJ
510(k) summary
Summary
Third party review
No

Clearances, product code MEH

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