510(k) · Cleared
Recalled · Class II · 2014Pivot Bipolar Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Jul 7, 2005 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 7, 2005
- Review
- 80 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 2
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK050966 Pivot Bipolar Femoral HeadOrtho Development Corp. · 2005
- Descendant · cites it directly · 9 of its ownK091967 Medacta Bipolar HeadMedacta International S.A. · 2010
- Descendant · cites it directly · 7 of its ownK082705 Biopro Bipolar Head, Models 18130-18152Biopro, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
- Descendant · 2 generations on · 4 of its ownK100761 Biopro Polar HeadBiopro, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK241461 Mpact Constrained LinerMedacta International S.A. · 2025
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K091967Medacta Bipolar HeadMedacta International S.A. · 2010 · cites it directly9descendants
- K082705Biopro Bipolar Head, Models 18130-18152Biopro, Inc. · 2008 · cites it directly7descendants
- K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · 2 generations on5descendants
- K100761Biopro Polar HeadBiopro, Inc. · 2010 · 2 generations on4descendants
- K241461Mpact Constrained LinerMedacta International S.A. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050966 | Pivot Bipolar Femoral Head | Ortho Development Corp. | 2005 | — |
| +1 | K091967 | Medacta Bipolar Head | Medacta International S.A. | 2010 | — |
| +1 | K082705 | Biopro Bipolar Head, Models 18130-18152 | Biopro, Inc. | 2008 | — |
| +2 | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… | Signature Orthopaedics Pty Limited | 2014 | — |
| +2 | K100761 | Biopro Polar Head | Biopro, Inc. | 2010 | 1 |
| +2 | K241461 | Mpact Constrained Liner | Medacta International S.A. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 172 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 |
|---|---|---|---|---|
| Jul 11, 2014 | Class II | Z-2253-2014 | Packaging process control | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which… |
| Apr 29, 2009 | Not classified | Z-0086-2010 | Device Design | A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091967 (Medacta International S.A., 2010) has gone furthest, with 9 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 device is intended for use in hip arthroplasty in cemented and uncemented primary or revision applications whose indications include:
1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis.
2. Proximal femoral neck fractures or dislocation.
3. Idiopathic avascular necrosis of the femoral head.
4. Non-union of proximal femoral neck fractures.
5. Treatment of fractures that are unmanageable using other forms of therapy.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050966: Pivot Bipolar 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/K050966
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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