510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123604Substantially Equivalent

Abg III Monolithic Hip Stem

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

K123604 is the FDA 510(k) clearance record for ABG III MONOLITHIC HIP STEM, a class II device, cleared for Howmedica Osteonics Corp. on under FDA product code MAY (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish). FDA records list 377 510(k) clearances for Howmedica Osteonics Corp., from to . As of , FDA records show one recall naming K123604.

Clearance record

Decision date
Received
(268 days to decision)
Product code
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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 MAY

Trailing 12 months

FDA records hold no clearances under product code MAY in the trailing twelve months.

FDA records show no clearances under product code MAY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MAY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260