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
K130422Substantially Equivalent

Phantom Fiber Biofiber Suture

TORNIER Inc., Bloomington MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130422 is the FDA 510(k) clearance record for PHANTOM FIBER BIOFIBER SUTURE, a class II device, cleared for Tornier, Inc. on under FDA product code NWJ (Suture, Recombinant Technology). FDA's definition for product code NWJ reads: "Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation". FDA records list 140 510(k) clearances for Tornier, Inc., from to . As of , FDA records show one recall naming K130422.

Clearance record

Decision date
Received
(43 days to decision)
Product code
NWJ Suture, Recombinant Technology
Regulation
21 CFR 878.4494
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Tornier, Inc. 10801 Nesbitt Ave., Bloomington MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NWJ

Trailing 12 months

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

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