510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K123425Substantially Equivalent

Twinfix Ti 3.5Mm Suture Anchor with Two Ultrabraid Suture #2 with Needles, Sl

Smith & Nephew, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123425 is the FDA 510(k) clearance record for TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K123425.

Clearance record

Decision date
Received
(105 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Smith & Nephew, Inc. 150 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBI

Trailing 12 months
30 clearances under product code MBI in the twelve months to November 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260
November 20260