510(k) · Cleared
ClearedU2 Bipolar Implant and 22mm Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Apr 7, 2016 as substantially equivalent to K101670 (United Orthopedic Corp., 2010) and 6 other predicates after a 224-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it.
- Decided
- Apr 7, 2016
- Review
- 224 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K941847 (1994). 64 ancestors in all, the oldest K800207 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 5 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 4 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 2 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 1 generation backK060707 Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006
- This deviceK152439 U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
- Descendant · cites it directly · 1 of its ownK162957 U2 Femoral HeadUnited Orthopedic Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022
- Descendant · cites it directly · 0 of its ownK173455 SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −6 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −5 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −4 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −1 | K060707 | Aesculap Bipolar Acetabular Cup | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016 | — |
| +1 | K162957 | U2 Femoral Head | United Orthopedic Corporation | 2017 | — |
| +2 | K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | 2022 | — |
| +1 | K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K101670 | United U2 Bipolar ImplantSummary page 4…Panel. Device Class Class II Classification Panel Orthopaedics Product Code KWY Predicate Device 1. “United” U2 Bipolar Implant (K101670) 2. “United” U1 Hip System-Bipolar (K050269) 3. “United” U1 Hip System--Femor… | 2010 |
| * | K050269 | U1 Hip System - BipolarSummary page 4…rthopaedics Product Code KWY Predicate Device 1. “United” U2 Bipolar Implant (K101670) 2. “United” U1 Hip System-Bipolar (K050269) 3. “United” U1 Hip System--Femoral Head (K994078) 4. “Stryker” UHR Universal… | 2005 |
| * | K994078 | U1 Hip SystemSummary page 4…ed” U2 Bipolar Implant (K101670) 2. “United” U1 Hip System-Bipolar (K050269) 3. “United” U1 Hip System--Femoral Head (K994078) 4. “Stryker” UHR Universal Head Bipolar System (K800207)… | 2000 |
| * | K800207 | Uhr UNIVERSAL6HIP ReplacementSummary page 4…3. “United” U1 Hip System--Femoral Head (K994078) 4. “Stryker” UHR Universal Head Bipolar System (K800207) 5. “Zimmer” VerSys Hip System--Femoral Head (K964769) 6. “Exactech” AcuMatch… | 1980 |
| * | K964769 | Versys Hip System--Fiber Metal Taper Hip ProsthesisSummary page 4…4. “Stryker” UHR Universal Head Bipolar System (K800207) 5. “Zimmer” VerSys Hip System--Femoral Head (K964769) 6. “Exactech” AcuMatch L-Series Bipolar Endoprosthesis (K013211)… | 1997 |
| * | K013211 | Modification to: Acumatch L-Series Bipolar EndoprosthesisSummary page 4…5. “Zimmer” VerSys Hip System--Femoral Head (K964769) 6. “Exactech” AcuMatch L-Series Bipolar Endoprosthesis (K013211) 7. “Aesculap” Aesculap BiPolar Acetabular Cup (K060707) UOC-FDA-038… | 2001 |
| * | K060707 | Aesculap Bipolar Acetabular CupSummary page 4…6. “Exactech” AcuMatch L-Series Bipolar Endoprosthesis (K013211) 7. “Aesculap” Aesculap BiPolar Acetabular Cup (K060707) UOC-FDA-038 -----… | 2006 |
What descends from it? (3)
2 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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 21 of the 63 ancestors have a recall of any class.
- Of its descendants, K162957 (United Orthopedic Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K101670.
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. 2016, this device’s year, is highlighted.
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 intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:
1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.
2. Inflammatory degenerative joint disease such as rheumatoid arthritis.
3. Correction of function deformity.
4. Revision procedures where other treatments or devices have failed.
5. 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/K152439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152439: U2 Bipolar Implant and 22mm Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152439
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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