# K130063: Arcos Trochanter Button

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Apr 19, 2013 after 99 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: 6 generations back to K921308 (1994). 25 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090757: Biomet Modular Femoral Revision System, Biomet, Inc. (2009) Summary page 2.

## Most influential descendants
- K190100: USTAR II System (2019), 2 descendants of its own
- K252303: Stem Extension Line (USTAR II System) (2025), 0 descendants of its own
- K243656: U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (2025), 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. The Arcos Modular Femoral Revision System Trochanteric Button hip components are single-use implants, intended for uncemented applications.

Source page: https://510kreport.com/device/K130063
Methodology: https://510kreport.com/methodology