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Djo Surgical 343-10-710

by Encore Medical LP

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

5 closed

Documents

510(k) K160342

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888912172028 UDI-DI Date7 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160342 Date19 May 2016DecidedStatusActive

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0042-2018 FDA Class II initiated 15 Sep 2017
    • Terminated Z-0041-2018 FDA Class II initiated 15 Sep 2017

    It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

    • Terminated Z-1139-2017 FDA Class II initiated 10 Jan 2017

    The Empowr PS Insert was reported as missing the impaction slot feature.

    • Terminated Z-0325-2017 FDA Class II initiated 19 Sep 2016

    It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.

    • Terminated Z-0766-2017 FDA Class II initiated 19 Sep 2016

    It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.

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  • Withdrawn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
343-10-710
Primary DI / UDI-DI
00888912172028
510(k) Number
FDA product code
OIY, JWH
GMDN term
Cruciate-retaining total knee prosthesis
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibial insertCruciate-retaining total knee prosthesis

Cleared under the same submission (K160342)

Show all (12)

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)

  • Sterilise before use: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No