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Ortho Development Balanced Knee System

by Ortho Development Corp.

510(k) K994370

Active United States

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994370 Date24 Mar 2000ClearedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JWH
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ortho Development Balanced Knee System is a total knee arthroplasty system designed for knee replacement procedures. It is a flagship product within Ortho Development's Balanced Knee® solutions portfolio.

The system has been in clinical use for over 20 years and is supplied as a reusable surgical system. It received FDA 510(k) clearance (K994370) on March 24, 2000, and is classified under product code JWH with advisory committee review in orthopedics (OR).

Other devices from Ortho Development Corp.

See all devices from Ortho Development Corp. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ortho Development Balanced Knee System used for?

    The Ortho Development Balanced Knee System is designed for total knee arthroplasty procedures, serving as a flagship product in Ortho Development's Balanced Knee® solutions portfolio for knee replacement surgeries.

  • Is the Ortho Development Balanced Knee System reusable or single-use?

    The system is supplied as a reusable surgical system, meaning it is intended for multiple uses after appropriate cleaning and sterilization between procedures, as indicated in its description.

  • What regulatory clearance does the Ortho Development Balanced Knee System have?

    The Ortho Development Balanced Knee System received FDA 510(k) clearance (K994370) on March 24, 2000, and is classified under product code JWH with orthopedic advisory committee review.