# K140509: Biomet Side Access Distal Femoral Expandable

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, LLC
- Decided: May 28, 2014 after 89 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945028 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020381: Expandable Knee, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K152621: OSS/Arcos IM Total Femur Rod (2015), 0 descendants of its own

## Indications for use
The Biomet Side Access Distal Femoral Expandable 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 or with Biomet Compress®.

Source page: https://510kreport.com/device/K140509
Methodology: https://510kreport.com/methodology