# K040947: Durasul Bipolar

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Aug 27, 2004 after 137 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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 K873815 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873815: Ioi Bipolar Prosthesis, Intermedics Orthopedics (1987) Summary page 1.

## Cited in the summary but kept off the family tree
- K011321: Modification to XPS 3000 System, Medtronic Xomed, Inc. (2001). Our reading of the summary gave K011321, FDA’s number for Modification to XPS 3000 System (Medtronic Xomed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Exactech's AcuMatchLU-Series Bipolar”. Kept off the family tree.

## Indications for use
The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.

Source page: https://510kreport.com/device/K040947
Methodology: https://510kreport.com/methodology