# K031734: Generation 4 Polished Femoral Hip Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jul 1, 2003 after 27 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: 1 generation back to K023085 (2002). 1 ancestor in all.
12 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023085: RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K052639: Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer (2006), 11 descendants of its own
- K130610: Sirius Femoral Stem (2013), 10 descendants of its own
- 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

## Indications for use
The indications for use of the “Generation 4” Polished Femoral Hip Prosthesis include: 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 treatments or devices have failed. The “Generation 4” Polished Femoral Hip Prosthesis is intended for total hip arthroplasty, and is intended for cemented use only.

Source page: https://510kreport.com/device/K031734
Methodology: https://510kreport.com/methodology