Balanced Knee System 161-1403

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00822409007752 UDI-DI	Date31 Aug 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK994370	Date24 Mar 2000Decided	StatusActive

Official records

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).

1 jurisdiction

United States — FDA 510(k) Active

GUDID

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