# K050251: Balance Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 27, 2005 after 113 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- 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). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921181: Mallory-Head Total Hip System, Biomet, Inc. (1994) Summary page 2.
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components, Biomet, Inc. (2003) Summary page 2.
- K943230: Mayo Hip Prosthesis, Mayo Clinic (1997) Summary page 2.
- K921224: Bimetric Total Hip System, Biomet, Inc. (1994) Summary page 2.

## Most influential descendants
- K143009: Echo Bi-Metric Microplasty Hip System (2014), 1 descendant of its own
- K150503: Echo Bi-Metric Microplasty Line Extension (2015), 0 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 of previously failed total hip arthroplasty. Balance® Hip System Femoral Stems are intended for uncemented use only. 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 femoral head resurfacing components. Balance® Hip System Microplasty® Stems are intended for uncemented use only.

Source page: https://510kreport.com/device/K050251
Methodology: https://510kreport.com/methodology