# K020383: Ortho Development Balanced Knee Tibial Tray Pegged

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: May 6, 2002 after 90 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994370 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994370: Ortho Development Balanced Knee System, Ortho Development Corp. (2000) Summary page 1.
- (no number) Balanced Knee™ System (Ortho Development): named in the summary without a submission number
- (no number) Natural Knee System (Intermedics Orthopedics): named in the summary without a submission number
- (no number) Ortholoc Advantim System (Wright Medical): named in the summary without a submission number
- (no number) Consensus Knee System (Hayes Medical): named in the summary without a submission number

## Indications for use
The Balanced Knee™ Tibial Tray Pegged 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; e Rheumatoid arthritis of the knee joint; v Post-traumatic arthritis of the knee joint; » Moderate valgus, varus, or flexion deformities. The Ortho Development Balanced Knee™ Tibial Tray Pegged is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bane disease such as rheumatoid arthritis or ostaoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use oniy.

Source page: https://510kreport.com/device/K020383
Methodology: https://510kreport.com/methodology