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Truliant, Activit-E 02-024-35-1013

by Exactech, Inc.

Truliant, Activit-E 02-024-35-1013 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K223252 on 17 Jul 2023 and listed in FDA GUDID since 12 Sep 2023 (UDI-DI 10885862596666), active as of 23 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

Documents

510(k) K223252

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 Number10885862596666 UDI-DI Date12 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223252 Date17 Jul 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223252 decided 17 Jul 2023 Active
  • FDA GUDID UDI-DI 10885862596666 listed 12 Sep 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0586-2024 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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K223252
  2. Listed FDA GUDID 10885862596666
  3. Recall initiated FDA recalls Z-0586-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Truliant, Activit-E
Generic name
Tibial insert
Model / Ref / Catalog
02-024-35-1013
Primary DI / UDI-DI
10885862596666
510(k) Number
FDA product code
OIY, JWH
GMDN term
Tibial insert
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibial insert

Cleared under the same submission (K223252)

and 8 more cleared under K223252

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)