510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K061493Substantially Equivalent

Apex Pins

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

K061493 is the FDA 510(k) clearance record for APEX PINS, a class II device, cleared for Stryker Howmedica Osteonics on under FDA product code JDW (Pin, Fixation, Threaded). FDA records list 377 510(k) clearances for HOWMEDICA OSTEONICS CORP, from to . As of , FDA records show no recalls naming K061493.

Clearance record

Decision date
Received
(37 days to decision)
Product code
JDW Pin, Fixation, Threaded
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker Howmedica Osteonics 325 Corporate Dr., Mahwah NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDW

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