Skip to content

Tfn-Advance 04.037.013S

by Synthes

Tfn-Advance 04.037.013S (04037013S) is a Class II device made by Synthes, cleared under FDA 510(k) K160167 on 26 Sep 2016 (1 earlier submission) and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982095718), active as of 23 Oct 2026. 9 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160167 Date26 Sep 2016DecidedStatusActive
United StatesGUDID listing Number10886982095718 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160167 decided 26 Sep 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10886982095718 listed 14 Sep 2015 Listed

Recalls

9 recalls · 5 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1239-2024 FDA Class II initiated 24 Jan 2024
    • Ongoing Z-1240-2024 FDA Class II initiated 24 Jan 2024

    Products not sterilized, sterility cannot be confirmed

  • 3 recalls, same reason

    • Ongoing Z-1247-2023 FDA Class II initiated 1 Feb 2023
    • Ongoing Z-1246-2023 FDA Class II initiated 1 Feb 2023
    • Ongoing Z-1248-2023 FDA Class II initiated 1 Feb 2023

    TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length

    • Terminated Z-0126-2016 FDA Class II initiated 21 Sep 2015

    Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.

    • Terminated Z-2091-2015 FDA Class II initiated 10 Jun 2015

    The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).

    • Terminated Z-1600-2015 FDA Class II initiated 9 Apr 2015

    TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.

    • Terminated Z-1352-2015 FDA Class II initiated 24 Feb 2015

    The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-1600-2015
  2. Recall initiated FDA recalls Z-2091-2015
  3. Listed FDA GUDID 10886982095718
  4. Recall initiated FDA recalls Z-0126-2016
  5. Cleared FDA 510(k) K160167
  6. Recall initiated FDA recalls Z-1247-2023
  7. Recall initiated FDA recalls Z-1246-2023
  8. Recall initiated FDA recalls Z-1248-2023
  9. Recall initiated FDA recalls Z-1239-2024
  10. Recall initiated FDA recalls Z-1240-2024

2 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tfn-Advance
Generic name
Femur intramedullary nail
Model / Ref / Catalog
04.037.013S, 04037013S
Primary DI / UDI-DI
10886982095718
510(k) Number
FDA product code
HSB
GMDN term
Femur intramedullary nail
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Femur intramedullary nail

Cleared under the same submission (K131548)

and 8 more cleared under K131548

Cleared under the same submission (K160167)

and 8 more cleared under K160167

Other devices from Synthes

  • 68.134.011

    Class II

  • Volt 68.134.111

    Class II

  • Volt 68.134.200

    Class II

  • 68.045.017

    Class II

See all devices from Synthes →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)