FDA 510(k) clearance · back to tracker

Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)

Smith & Nephew, Inc. cleared K261968 on 2026-07-09, decision: substantially equivalent

K-number

K261968

Sponsor

Smith & Nephew, Inc.

Device

Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-09

Product code

MBI

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3040

Official FDA record

Open K261968on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.