# K080330: Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female Taper

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 11, 2008 after 126 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: 5 generations back to K945028 (1996). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043547: Compress Segmental Femoral Replacement System, Biomet, Inc. (2005) Summary page 1.
- K062998: Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug), Biomet Manufacturing Corp (2007) Summary page 1.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 1.
- K052685: Orthopedic Salvage System- Oss, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (2015), 1 descendant of its own
- K253515: Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments (2026), 0 descendants of its own

## Indications for use
Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis. 2. Correction of varus, valgus or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. Ligament deficiencies 5. Tumor resections 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques 7. Revision of previously failed total joint arthroplasty 8. Trauma These devices are to be used with bone cement unless a proximal femur is indicated for use (USA) When used with Biomet's Compress ® Segmental Femoral Replacement System, the indications for use are uncemented application in cases of: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma.

Source page: https://510kreport.com/device/K080330
Methodology: https://510kreport.com/methodology