510(k) · Cleared
Recalled · Class II · 2024Smith & Nephew Global Bipolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Jan 23, 2003 after a 77-day review. The FDA summary names its predicate without a number. 35 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 23, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 3
- Predicates
- 0
35 later devices descend from it, 5 citing it directly.
- This deviceK023743 Smith & Nephew Global Bipolar SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 19 of its ownK061243 Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 18 of its ownK062408 Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc. · 2006
- Descendant · 3 generations on · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
- Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 4 generations on · 7 of its ownK113848 R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K061243Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc. · 2006 · cites it directly19descendants
- K062408Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc. · 2006 · 2 generations on18descendants
- K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · 3 generations on16descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
- K113848R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023743 | Smith & Nephew Global Bipolar System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K061243 | Smith & Nephew Modular Femoral Head | Smith & Nephew, Inc. | 2006 | 1 |
| +2 | K062408 | Smith & Nephew Modular Femoral (Hemi) Head | Smith & Nephew, Inc. | 2006 | — |
| +3 | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, Inc. | 2010 | — |
| +1 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +4 | K113848 | R3 Xlpe Liners | Smith & Nephew, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Smith & Nephew Bipolar System Named without a submission number | |
| * | — | Centrax Bipolar System Named without a submission number | |
| * | — | Multipolar Bipolar System Named without a submission number | |
| * | — | Self-Centering Bipolar System Named without a submission number | |
| * | — | Ringloc Bipolar System Named without a submission number |
What descends from it? (35)
See all 355 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2024 | Class II | Z-0326-2025 | Under Investigation by firm | The Bipolar assembly contains an oversized Retainer Ring. |
| Aug 29, 2016 | Class II | Z-0350-2017 | Process control | Some Bipolar shells were manufactured with an out of specification retainer groove. |
| Aug 29, 2016 | Class II | Z-0351-2017 | Process control | Some Bipolar shells were manufactured with an out of specification retainer groove. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061243 (Smith & Nephew, Inc., 2006) has gone furthest, with 19 descendants of its own.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023743 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023743: Smith & Nephew Global Bipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023743
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026