# K031201: Ortho Development Balanced Knee Modular Tibial System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jul 15, 2003 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) PFC Sigma Total Knee System: named in the summary without a submission number
- (no number) Duracon Total Knee System: named in the summary without a submission number
- (no number) Foundation Total Knee System: named in the summary without a submission number

## Most influential descendants
- K103837: Balanced Knee System Revision Offset Tibia (2011), 0 descendants of its own

## Recalls of this device
- Mar 19, 2009 · Not classified · Z-1229-2010: A component of knee prosthesis was assembled incorrectly.
- Mar 19, 2009 · Not classified · Z-1228-2010: A component of knee prosthesis was assembled incorrectly.

## Indications for use
The Balanced KneeTMTibial 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; Rheumatoid arthritis of the knee joint; Post-traumatic arthritis of the knee joint; Moderate valgus, varus, or flexion deformities; Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K031201
Methodology: https://510kreport.com/methodology