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Phantom Fiber Biofiber Suture

by Tornier, Inc.

510(k) K130422

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK130422 Date4 Apr 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1374-2018 FDA Class II initiated 8 Feb 2018

    Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NWJ
Device Class
Class II
Regulation
21 CFR Part 878.4494
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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