# K090705: Balanced Knee System Ultracongruent Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Oct 9, 2009 after 206 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923277 (1993). 14 ancestors in all.
42 later devices descend from it; 3 cite it directly.
0 of 57 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). Our reading of the summary gave K994770, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ortho Development Corporation Balanced Knee System CR or PS Insert”. Summary page 2.
- K033272: Depuy Sigma Tibial Inserts, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- P830055: LCS (R) Total Knee System, Depuy, Inc. (1985) Summary page 1.
- K923277: Foundation Knee System, Encore Orthopedics, Inc. (1993) Summary page 1.
- K001456: Consensus Knee System, Hayes Medical, Inc. (2000)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K000666: TC-Plus Solution Knee, Plus Orthopedics (2000) Summary page 1.
- K872379: Insall/Burstein* II Modular Total Knee, Zimmer, Inc. (1987) Summary page 1.
- K912663: Natural-Knee Ultra Congruent Tibial Insert, Intermedics Orthopedics (1991) Summary page 1.
- K936159: Natural-Knee II System, Intermedics Orthopedics (1995) Summary page 1.

## Most influential descendants
- 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
- K150105: Klassic Knee System-Sombrero Patella (2015), 24 descendants of its own

## Recalls of this device
- Jul 11, 2014 · Class II · Z-2256-2014: 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

## Indications for use
The Ortho Development Balanced Knee ® System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4., Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities. 6. Revision procedures where other treatments or devices have failed. The Balanced Knee® System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.

Source page: https://510kreport.com/device/K090705
Methodology: https://510kreport.com/methodology