# K994370: Ortho Development Balanced Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Mar 24, 2000 after 88 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
47 later devices descend from it; 6 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Performance Total Knee System (Kirschner): named in the summary without a submission number
- (no number) NexGen Total Knee System (Zimmer): named in the summary without a submission number
- (no number) PCA Modular Total Knee System (Howmedica): named in the summary without a submission number
- (no number) Natural Knee System (Intermedics): named in the summary without a submission number
- (no number) AGC Modular Total Knee System (Biomet): named in the summary without a submission number
- (no number) Foundation Total Knee System (Encore): named in the summary without a submission number

## Most influential descendants
- K090705: Balanced Knee System Ultracongruent Tibial Insert (2009), 42 descendants of its own
- K112906: Klassic Knee System (2012), 33 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own
- K153310: Klassic Knee System (2015), 24 descendants of its own
- K153075: Klassic Knee System (2015), 24 descendants of its own

## Recalls of this device
- May 30, 2019 · Class II · Z-1903-2020: 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
- May 30, 2019 · Class II · Z-1904-2020: 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
- Jul 11, 2014 · Class II · Z-2255-2014: 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 int
- Jul 11, 2014 · Class II · Z-2254-2014: 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 int
- Apr 1, 2014 · Class II · Z-1610-2014: A femoral component containing pegs was found in a box for the pegless version.
- May 29, 2009 · Not classified · Z-1993-2009: 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).

## Indications for use
The Balanced Knee'™ System is intended for single use in primary total knee replacement only. Indications include: Loss of joint configuration and joint function; Osteoarthritis of the knee joint; Rheumatoid arthritis of the knee joint; Post-traumatic arthritis of the knee joint; Moderate valgus, varus, or flexion deformities.

Source page: https://510kreport.com/device/K994370
Methodology: https://510kreport.com/methodology