510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222978Substantially Equivalent

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Xiros Ltd, Leeds, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222978 is the FDA 510(k) clearance record for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, a class II device, cleared for Xiros, Ltd. on under FDA product code QUW (Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament). FDA's definition for product code QUW reads: "a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair". FDA records list 11 510(k) clearances for Xiros, Ltd., from to . As of , FDA records show no recalls naming K222978.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QUW Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Xiros, Ltd. Springfield House Ln., Whitehouse Ln., Leeds, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QUW

Trailing 12 months
2 clearances under product code QUW in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QUW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260