510(k) · Cleared
ClearedMedacta Bipolar Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Mar 2, 2010 as substantially equivalent to K082468 (Omni Life Science, Inc., 2009) and 3 other predicates after a 244-day review. Its family tree reaches back 3 generations to 1995. 9 later devices descend from it.
- Decided
- Mar 2, 2010
- Review
- 244 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K953510 (1995). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK953510 Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented…Encore Orthopedics, Inc. · 1995 · Recalled
- 2 generations backK982447 Plus Bipolar Prosthesis CocrmoPlus Orthopedics · 1998
- 1 generation backK082468 Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in…Omni Life Science, Inc. · 2009 · Recalled
- This deviceK091967 Medacta Bipolar HeadMedacta International S.A. · 2010
- Descendant · cites it directly · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
- Descendant · cites it directly · 1 of its ownK241461 Mpact Constrained LinerMedacta International S.A. · 2025
- Descendant · 2 generations on · 1 of its ownK143184 Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · 2 generations on · 0 of its ownK243043 Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · cites it directly5descendants
- K241461Mpact Constrained LinerMedacta International S.A. · 2025 · cites it directly1descendant
- K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015 · 2 generations on1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
- K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953510 | Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis | Encore Orthopedics, Inc. | 1995 | 18 |
| −2 | K982447 | Plus Bipolar Prosthesis Cocrmo | Plus Orthopedics | 1998 | — |
| −1 | K082468 | Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM]… | Omni Life Science, Inc. | 2009 | 23 |
| 0 (this device) | K091967 | Medacta Bipolar Head | Medacta International S.A. | 2010 | — |
| +1 | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… | Signature Orthopaedics Pty Limited | 2014 | — |
| +1 | K241461 | Mpact Constrained Liner | Medacta International S.A. | 2025 | — |
| +2 | K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015 | — |
| +2 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +2 | K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K082468 | Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD…Summary page 1…is 21 CFR 888.3390 Class 11 Device Product Code: KW~Y Predicate Devices: K082468 Apex Hip System Bipolar Head K050966 Ortho Development Pivot Bipolar Head… | 2009 |
| * | K050966 | Pivot Bipolar Femoral HeadSummary page 1…Class 11 Device Product Code: KW~Y Predicate Devices: K082468 Apex Hip System Bipolar Head K050966 Ortho Development Pivot Bipolar Head K014072 Disc-O-Tech Medical Technologies Ltd's… | 2005 |
| * | K014072 | Fixion Unipolar Modular Hemi-Hip System (Fixion UH)Summary page 1…Predicate Devices: K082468 Apex Hip System Bipolar Head K050966 Ortho Development Pivot Bipolar Head K014072 Disc-O-Tech Medical Technologies Ltd's Fixion TM Unipolar Modular Hemi-Hip System… | 2002 |
| * | K982447 | Plus Bipolar Prosthesis CocrmoSummary page 1…K014072 Disc-O-Tech Medical Technologies Ltd's Fixion TM Unipolar Modular Hemi-Hip System K982447 Plus Orthopedics PLUS Bipolar Heads Medacta Bipolar Heads 510(k) Section 5 -Page 2 of 4 === Pag… | 1998 |
What descends from it? (9)
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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K133370 (Signature Orthopaedics Pty Limited, 2014) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K082468.
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. 2010, 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?
The Medacta® Bipolar Head is intended for use in combination with Medacta® Hip Prosthesis System and Mectacer femoral heads for uncemented primary or revision hemniarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
* Femoral neck and trochanteric fractures of the proximal femur;
* Osteonecrosis of the femoral head;
* Revision procedures where other devices or treatments for these indications have failed,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091967: Medacta Bipolar Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091967
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