# K142295: Sirius Femoral Stem, Size 30A

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Sep 15, 2014 after 28 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: 4 generations back to K023085 (2002). 6 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130610: Sirius Femoral Stem, Biomet, Inc. (2013) Summary page 5.

## Most influential descendants
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (2020), 6 descendants of its own
- K213701: Exeter® X3® RimFit® Cup (2022), 5 descendants of its own
- K191414: EXETER Centralizer, EXETER 2.5mm Plug (2019), 5 descendants of its own
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own

## Indications for use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision procedures where other treatment or devices have failed. The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.

Source page: https://510kreport.com/device/K142295
Methodology: https://510kreport.com/methodology