510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112556Substantially Equivalent

Adm and Adm/mdm Duration Inserts, Adm and Adm/mdm X3 Inserts

Howmedica Osteonics Corp, Mahwah NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112556 is the FDA 510(k) clearance record for ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS, 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 one recall naming K112556.

Clearance record

Decision date
Received
(26 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. 325 Corporate Dr., Mahwah NJ
510(k) summary
Summary PDF
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