# K020381: Expandable Knee

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: May 6, 2002 after 90 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945028 (1996). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945028: Finn Knee System, Biomet, Inc. (1996) Summary page 1.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 1.

## Most influential descendants
- K140509: Biomet Side Access Distal Femoral Expandable (2014), 1 descendant of its own
- K152621: OSS/Arcos IM Total Femur Rod (2015), 0 descendants of its own
- K122015: Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, Wedge (2013), 0 descendants of its own

## Recalls of this device
- Jun 5, 2017 · Class II · Z-0304-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Jun 5, 2017 · Class II · Z-0305-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

## Indications for use
The Expandable Knee offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement. The devices are single use implants intended for implantation with bone cement.

Source page: https://510kreport.com/device/K020381
Methodology: https://510kreport.com/methodology