# K070274: Echo BI-Metric Press-Fit Stems

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Apr 3, 2007 after 64 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953925 (1996). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063002: Altra Press-Fit Hip System, Biomet Manufacturing Corp (2006) Summary page 1.

## 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

## Recalls of this device
- Jun 8, 2018 · Class II · Z-2821-2018: Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
- Jun 5, 2017 · Class II · Z-0300-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Nov 6, 2012 · Class II · Z-0442-2013: It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

## Indications for use
1. Noninflammatory 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 Echo TM Bi-Metric® Press-Fit Stems are intended for uncemented use only.

Source page: https://510kreport.com/device/K070274
Methodology: https://510kreport.com/methodology