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Djo Surgical 392-15-705

by Encore Medical LP

Djo Surgical 392-15-705 is a Class II device made by Encore Medical LP, cleared under FDA 510(k) K091956 on 28 Sep 2010 and listed in FDA GUDID since 7 Aug 2017 (UDI-DI 00888912121019), active as of 8 Nov 2026. 4 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

None ongoing

4 closed

Documents

510(k) K091956

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888912121019 UDI-DI Date7 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091956 Date28 Sep 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091956 decided 28 Sep 2010 Active
  • FDA GUDID UDI-DI 00888912121019 listed 7 Aug 2017 Listed

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2659-2017 FDA Class II initiated 31 May 2017
    • Terminated Z-2658-2017 FDA Class II initiated 31 May 2017

    Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.

    • Terminated Z-1213-2013 FDA Class II initiated 1 Apr 2013

    U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.

    • Terminated Z-2302-2012 FDA Class II initiated 9 Aug 2012

    The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.

Timeline

6 dated events

  1. Cleared FDA 510(k) K091956
  2. Recall initiated FDA recalls Z-2302-2012
  3. Recall initiated FDA recalls Z-1213-2013
  4. Recall initiated FDA recalls Z-2659-2017
  5. Recall initiated FDA recalls Z-2658-2017
  6. Listed FDA GUDID 00888912121019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Djo Surgical
Generic name
Cruciate-retaining total knee prosthesis
Model / reference
392-15-705
Primary DI / UDI-DI
00888912121019
510(k) Number
FDA product code
OIY, MBH, JWH
GMDN term
Cruciate-retaining total knee prosthesis
Device class
Class II
Regulation number
888.3560, 888.3565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibial insertCruciate-retaining total knee prosthesis

Cleared under the same submission (K091956)

and 8 more cleared under K091956

Other devices from Encore Medical LP

See all devices from Encore Medical LP →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)