# K173455: SurgTech Bipolar Head System

- Pathway: 510(k) (Traditional)
- Applicant: Surgtech, Inc.
- Decided: Jun 14, 2018 after 219 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: 8 generations back to K941847 (1994). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931655: P.F.C. Bipolar Hip System, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 4.
- K152439: U2 Bipolar Implant and 22mm Femoral Head, United Orthopedic Corporation (2016) Summary page 4.
- K800207: Uhr UNIVERSAL6HIP Replacement, Osteonics Corp. (1980) Summary page 4.
- K855231: Howmedica Bipolar Prosthesis, Howmedica Corp. (1986) Summary page 4.

## Indications for use
The SurgTech Bipolar Head system is intended for use for cases of: • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia. • Inflammatory degenerative joint disease such as rheumatoid arthritis. • Correction of function deformity. • Revision procedures where other treatments or devices have failed. • Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K173455
Methodology: https://510kreport.com/methodology