# K193546: Distal Centralizers

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 25, 2020 after 280 days
- Product code: JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942479 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942479: Integral CO-CR Femoral Component, Biomet, Inc. (1994) Summary page 4.

## Most influential descendants
- K212431: Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (2022), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K193546
Methodology: https://510kreport.com/methodology