510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250544Substantially Equivalent

Knotilus+ Biocomposite Knotless Anchor

Stryker Corp., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250544 is the FDA 510(k) clearance record for Knotilus+ Biocomposite Knotless Anchor, a class II device, cleared for Stryker Endoscopy on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show no recalls naming K250544.

Clearance record

Decision date
Received
(87 days to decision)
Product code
MAI Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker Endoscopy 5900 Optical Ct., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAI

Trailing 12 months
5 clearances under product code MAI in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260