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Balanced Knee System 163-5611

by Ortho Development Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00822409041329 UDI-DI Date28 May 2019ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1903-2020 FDA Class II initiated 30 May 2019
    • Ongoing Z-1904-2020 FDA Class II initiated 30 May 2019

    The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.

  • 2 recalls, same reason

    • Terminated Z-2255-2014 FDA Class II initiated 11 Jul 2014
    • Terminated Z-2254-2014 FDA Class II initiated 11 Jul 2014

    Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

    • Terminated Z-1610-2014 FDA Class II initiated 1 Apr 2014

    A femoral component containing pegs was found in a box for the pegless version.

    • Terminated Z-1993-2009 FDA Unclassified (pre-2012) initiated 29 May 2009

    Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891).

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Balanced Knee System
Generic Name
Tibial insert
Model / Reference
163-5611
Primary DI / UDI-DI
00822409041329
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 — 11 Millimeter

Related devices

Category: Tibial insert

Cleared under the same submission (K994370)

Show all (12)

Other devices from Ortho Development Corp.

See all devices from Ortho Development Corp. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No