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Truliant 02-022-35-4512

by Exactech, Inc.

Truliant 02-022-35-4512 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K171045 on 28 Apr 2017 and listed in FDA GUDID since 7 Jul 2017 (UDI-DI 10885862304551), active as of 23 Oct 2026. 2 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

2 ongoing

This device is named in the recall

Documents

510(k) K171045

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862304551 UDI-DI Date7 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK171045 Date28 Apr 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171045 decided 28 Apr 2017 Active
  • FDA GUDID UDI-DI 10885862304551 listed 7 Jul 2017 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0585-2024 FDA Class II initiated 21 Nov 2023

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

    • Ongoing Z-0023-2022 FDA Class II initiated 30 Aug 2021

    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Timeline

4 dated events

  1. Cleared FDA 510(k) K171045
  2. Listed FDA GUDID 10885862304551
  3. Recall initiated FDA recalls Z-0023-2022
  4. Recall initiated FDA recalls Z-0585-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Truliant
Generic name
Tibial insert
Model / Ref / Catalog
02-022-35-4512
Primary DI / UDI-DI
10885862304551
510(k) Number
FDA product code
JWH
GMDN term
Tibial insert
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Size
Height — 12 Millimeter

Related devices

Category: Tibial insert

Cleared under the same submission (K171045)

and 8 more cleared under K171045

Similar devices in this category

Other devices filed under Tibial insert.

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (9, all answered No)