510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955305Substantially Equivalent

Pca +15Mm Modular Femoral Head

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

K955305 is the FDA 510(k) clearance record for PCA +15MM MODULAR FEMORAL HEAD, a class II device, cleared for Howmedica Corp. on under FDA product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate). FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K955305.

Clearance record

Decision date
Received
(59 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 Corp. 359 Veterans Blvd., Rutherford NJ
510(k) summary
Summary
Third party review
No

Clearances, product code MEH

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