# K052089: XR-Series BI-Metric Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Feb 17, 2006 after 199 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854046 (1985). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020580: X-Series BI-Metric Hip Femoral Components, Biomet, Inc. (2002) Summary page 1.
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K073637: Parallel-Sided Extensively Coated Femoral Stems (2008), 0 descendants of its own

## Indications for use
The XR-Series Bi-Metric® Femoral Components are intended for cemented or uncemented use in cases of: 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 of previously failed total joint replacement.

Source page: https://510kreport.com/device/K052089
Methodology: https://510kreport.com/methodology