# K130610: Sirius Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 30, 2013 after 176 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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: 3 generations back to K023085 (2002). 5 ancestors in all.
10 later devices descend from it; 2 cite 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)
- K052639: Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer, Biomet Manufacturing, Inc. (2006) Summary page 2.
- K960658: Collarless Polished Taper Hip Prosthesis, Zimmer, Inc. (1996) Summary page 2.

## Most influential descendants
- K142295: Sirius Femoral Stem, Size 30A (2014), 9 descendants of its own
- 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

## Recalls of this device
- Dec 2, 2014 · Class II · Z-0822-2015: After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 34B
- Dec 2, 2014 · Class II · Z-0823-2015: After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 348

## 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 by 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/K130610
Methodology: https://510kreport.com/methodology