# K150503: Echo Bi-Metric Microplasty Line Extension

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Mar 25, 2015 after 27 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: 8 generations back to K850055 (1985). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143009: Echo Bi-Metric Microplasty Hip System, Biomet, Inc. (2014) Summary page 4.

## 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. Porous coated components are intended for uncemented, biological fixation.

Source page: https://510kreport.com/device/K150503
Methodology: https://510kreport.com/methodology