# K090208: Biopro Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: May 22, 2009 after 114 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 9, 2025 · Class II · Z-0148-2026: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- Sep 21, 2011 · Not classified · Z-0163-2012: BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
- Sep 21, 2011 · Not classified · Z-0164-2012: BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.

## Indications for use
The BioPro Femoral Heads are indicated for use for significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis; revision of failed femoral head replacement, cup arthroplasty, or other hip procedures; proximal femoral fractures, avascular necrosis of the femoral head; non-union of proximal femoral neck fractures; other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The BioPro hip system (PSL) is for cemented and non-cemented use.

Source page: https://510kreport.com/device/K090208
Methodology: https://510kreport.com/methodology