# K052639: Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: May 3, 2006 after 219 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: 2 generations back to K023085 (2002). 3 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031734: Generation 4 Polished Femoral Hip Prosthesis, Biomet, Inc. (2003) Summary page 2.
- K023085: RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem, Biomet Orthopedics, Inc. (2002) Summary page 2.
- K942028: RX90 Femoral Component, Biomet, Inc. (1994) Summary page 2.

## Most influential descendants
- 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
- K213701: Exeter® X3® RimFit® Cup (2022), 5 descendants of its own

## Indications for use
The indications for use for the Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer 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 of previously failed total hip arthroplasty. The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties.

Source page: https://510kreport.com/device/K052639
Methodology: https://510kreport.com/methodology