# K152621: OSS/Arcos IM Total Femur Rod

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Oct 14, 2015 after 30 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921308 (1994). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033871: IM Total Femur, Biomet, Inc. (2004) Summary page 4.
- K123501: Oss Modular Stems, Oss Diaphyseal Segments, Biomet, Inc. (2013) Summary page 4.
- K912712: Biomet Modular Total Hip Femoral Components, Biomet, Inc. (1991) Summary page 4.
- K090757: Biomet Modular Femoral Revision System, Biomet, Inc. (2009) Summary page 4.
- K141331: Biomet Orthopaedic Salvage System (Oss), Biomet, Inc. (2014) Summary page 4.
- K140509: Biomet Side Access Distal Femoral Expandable, Biomet Manufacturing, LLC (2014) Summary page 4.

## Indications for use
OSS INDICATIONS 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. Ligament deficiencies. 5. Tumor resections. 6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures 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 composed of OsseoTi (titanium alloy, not licensed in Canada) or a proximal femur is indicated for use (USA). Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA). *Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. COMPRESS INDICATIONS The Compress Segmental Femoral Replacement System is indicated for: 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. The Compress Segmental Femoral Replacement System components are intended for uncemented use. ‘When components of the Orthopaedic Salvage System are used with Biomet’s Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information. EXPANDABLE INDICATIONS 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/K152621
Methodology: https://510kreport.com/methodology