510(k) · Cleared
ClearedU1 Hip System - Bipolar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corp. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Aug 29, 2005 as substantially equivalent to K981238 (Whiteside Biomechanics, Inc., 1998) after a 206-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it.
- Decided
- Aug 29, 2005
- Review
- 206 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981238 (1998). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK981238 Bipolar Femoral HeadWhiteside Biomechanics, Inc. · 1998
- This deviceK050269 U1 Hip System - BipolarUnited Orthopedic Corp. · 2005
- Descendant · cites it directly · 5 of its ownK101670 United U2 Bipolar ImplantUnited Orthopedic Corp. · 2010 · Recalled
- Descendant · cites it directly · 3 of its ownK152439 U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK162957 U2 Femoral HeadUnited Orthopedic Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK173455 SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101670United U2 Bipolar ImplantUnited Orthopedic Corp. · 2010 · cites it directly5descendants
- K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016 · cites it directly3descendants
- K162957U2 Femoral HeadUnited Orthopedic Corporation · 2017 · 2 generations on1descendant
- K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022 · 3 generations on0descendants
- K173455SurgTech Bipolar Head SystemSurgtech, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981238 | Bipolar Femoral Head | Whiteside Biomechanics, Inc. | 1998 | — |
| 0 (this device) | K050269 | U1 Hip System - Bipolar | United Orthopedic Corp. | 2005 | — |
| +1 | K101670 | United U2 Bipolar Implant | United Orthopedic Corp. | 2010 | 1 |
| +1 | K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016 | — |
| +2 | K162957 | U2 Femoral Head | United Orthopedic Corporation | 2017 | — |
| +3 | K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | 2022 | — |
| +2 | K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K981238 | Bipolar Femoral HeadSummary page 1…, Hip, Hemi-, Femoral, Reference: Metal/Polymner, Cemented or Uncemented. Predicate Device: Whiteside Biomechanics Inc- Bipolar femoral head (K(981238) Device Description: The Ul Hip system - Bipolar is designated as a hemniarthroplasty component and is to be used with U… | 1998 |
What descends from it? (6)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K101670 (United Orthopedic Corp., 2010) has gone furthest, with 5 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?
This device is indicated in partial hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
* 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; and
* Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050269: U1 Hip System - Bipolar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050269
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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