# K023743: Smith & Nephew Global Bipolar System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 23, 2003 after 77 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew Bipolar System: named in the summary without a submission number
- (no number) Centrax Bipolar System: named in the summary without a submission number
- (no number) Multipolar Bipolar System: named in the summary without a submission number
- (no number) Self-Centering Bipolar System: named in the summary without a submission number
- (no number) Ringloc Bipolar System: named in the summary without a submission number

## Most influential descendants
- K061243: Smith & Nephew Modular Femoral Head (2006), 19 descendants of its own
- K062408: Smith & Nephew Modular Femoral (Hemi) Head (2006), 18 descendants of its own
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners (2010), 16 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K113848: R3 Xlpe Liners (2012), 7 descendants of its own

## Recalls of this device
- Oct 15, 2024 · Class II · Z-0326-2025: The Bipolar assembly contains an oversized Retainer Ring.
- Aug 29, 2016 · Class II · Z-0350-2017: Some Bipolar shells were manufactured with an out of specification retainer groove.
- Aug 29, 2016 · Class II · Z-0351-2017: Some Bipolar shells were manufactured with an out of specification retainer groove.

## Indications for use
The Global Bipolar System is indicated for the following: 1. Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; 2. rheumatoid arthritis; 3. arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; 4. revision procedures where other treatment or devices have failed; and 5. treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

Source page: https://510kreport.com/device/K023743
Methodology: https://510kreport.com/methodology