DeviceClearance

Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more— 510(k) K261968

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K261968 for Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more, Substantially Equivalent on 2026-07-09. Applicant: Smith & Nephew, Inc.. Device class: 2.

Summary

Smith & Nephew's Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, comes in two versions that swap suture colors: 72205981 (black knotless, blue MINITAPE) and 72205982 (blue knotless, black MINITAPE). Both are filed under MBI, nondegradable soft tissue fixation fasteners.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).

Smith & Nephew filed from Andover, Massachusetts. Review took 28 calendar days (June 11 to July 9, 2026).

Clearance details

Device name as filed
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)
Applicant
Smith & Nephew, Inc.
Product code
Product code MBI
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Andover, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.