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
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K051190Substantially Equivalent

Xenform Soft Tissue Repair Matrix

Integra LifeSciences Braintree Inc., Boston MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051190 is the FDA 510(k) clearance record for XENFORM SOFT TISSUE REPAIR MATRIX, a class II device, cleared for Tei Biosciences, Inc. on under FDA product code PAJ (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed). FDA's definition for product code PAJ reads: "Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy". FDA records list 16 510(k) clearances for Integra LifeSciences Braintree Inc., from to . As of , FDA records show no recalls naming K051190.

Clearance record

Decision date
Received
(31 days to decision)
Product code
PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Tei Biosciences, Inc. 7 Elkins St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAJ

Trailing 12 months

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

FDA records show no clearances under product code PAJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PAJ, 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