510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K222501Substantially Equivalent

Regeneten Bioinductive Implant

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

K222501 is the FDA 510(k) clearance record for Regeneten Bioinductive Implant, a class II device, cleared for Smith and Nephew, Inc. on under FDA product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon). FDA's definition for product code OWY reads: "For reinforcement of soft tissue where weakness exists in tendon repair". FDA records list 572 510(k) clearances for Smith and Nephew, Inc., from to . As of , FDA records show no recalls naming K222501.

Clearance record

Decision date
Received
(266 days to decision)
Product code
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Smith and Nephew, Inc. 150 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWY

Trailing 12 months

FDA records hold no clearances under product code OWY in the trailing twelve months.

FDA records show no clearances under product code OWY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OWY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260