510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954246Substantially Equivalent for Some Indications

Acufex Endofix Absorbable Interference Screw

Acufex Microsurgical, Inc., Mansfield MA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K954246 is the FDA 510(k) clearance record for ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW, a class II device, cleared for Acufex Microsurgical, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 78 510(k) clearances for Acufex Microsurgical, Inc., from to . As of , FDA records show no recalls naming K954246.

Clearance record

Decision date
Received
(157 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Acufex Microsurgical, Inc. 130 Forbes Blvd., Mansfield MA
Third party review
No

Clearances, product code HWC

Trailing 12 months
21 clearances under product code HWC in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20260