510(k) · Cleared
Recalled · Class II · 2025Biopro Polar Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopro, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Dec 3, 2010 as substantially equivalent to K082705 (Biopro, Inc., 2008) and 3 other predicates after a 261-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 2010
- Review
- 261 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K953510 (1995). 7 ancestors in all, the oldest K931655 (1994). 4 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 backK082705 Biopro Bipolar Head, Models 18130-18152Biopro, Inc. · 2008
- This deviceK100761 Biopro Polar HeadBiopro, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK191297 iNSitu Bipolar Hip SystemTheken Companies, LLC · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK243192 iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with…Nextstep Arthopedix, LLC · 2026
- Descendant · cites it directly · 0 of its ownK243634 Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK143113 Klassic BiPolar SystemTotal Joint Orthopedics · 2015 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K191297iNSitu Bipolar Hip SystemTheken Companies, LLC · 2019 · cites it directly1descendant
- K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC · 2026 · 2 generations on0descendants
- K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc. · 2025 · cites it directly0descendants
- K143113Klassic BiPolar SystemTotal Joint Orthopedics · 2015 · cites it directly0descendants
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 | K082705 | Biopro Bipolar Head, Models 18130-18152 | Biopro, Inc. | 2008 | — |
| 0 (this device) | K100761 | Biopro Polar Head | Biopro, Inc. | 2010 | — |
| +1 | K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | 2019 | 1 |
| +2 | K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed… | Nextstep Arthopedix, LLC | 2026 | — |
| +1 | K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K143113 | Klassic BiPolar System | Total Joint Orthopedics | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K082705 | Biopro Bipolar Head, Models 18130-18152Summary page 1…prosthesis orthopedic (OR) Regulatory Class Class 11per 21CFR 888.3390 Product Code KWY Legally Marketed K082705 (BioPro Bipolar Head) Predicate Device(s) K082468,1K945793,1<931655,1<11001511 Device Description… | 2008 |
| * | K082468 | Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD…Summary page 1…lass 11per 21CFR 888.3390 Product Code KWY Legally Marketed K082705 (BioPro Bipolar Head) Predicate Device(s) K082468,1K945793,1<931655,1<11001511 Device Description The BioPro Bipolar Head consist of a factory assembled Ultra High… | 2009 |
| * | K945793 | P.F.C.(R) Bipolar Hip System - 22MM BipolarSummary page 1…r 21CFR 888.3390 Product Code KWY Legally Marketed K082705 (BioPro Bipolar Head) Predicate Device(s) K082468,1K945793,1<931655,1<11001511 Device Description The BioPro Bipolar Head consist of a factory assembled Ultra High… | 1995 |
| * | K931655 | P.F.C. Bipolar Hip SystemSummary page 1…8.3390 Product Code KWY Legally Marketed K082705 (BioPro Bipolar Head) Predicate Device(s) K082468,1K945793,1<931655,1<11001511 Device Description The BioPro Bipolar Head consist of a factory assembled Ultra High… | 1994 |
| † | K100151 | Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM) | 2010 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2025 | Class II | Z-0150-2026 | Package design/selection | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K191297 (Theken Companies, LLC, 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K082705.
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 BioPro Bipolar Head is intended for use in combination with a BioPro PSL femoral stem for 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/K100761 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100761: Biopro Polar Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100761
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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