510(k) · Cleared
ClearedBiopro Bipolar Head, Models 18130-18152
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 15, 2008 as substantially equivalent to K050966 (Ortho Development Corp., 2005) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it.
- Decided
- Dec 15, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953510 (1995). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK953510 Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented…Encore Orthopedics, Inc. · 1995 · Recalled
- 1 generation backK982447 Plus Bipolar Prosthesis CocrmoPlus Orthopedics · 1998
- This deviceK082705 Biopro Bipolar Head, Models 18130-18152Biopro, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK100761 Biopro Polar HeadBiopro, Inc. · 2010 · Recalled
- 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 · 2 generations on · 0 of its ownK243634 Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK171156 OMNI Anseris Hip StemOmnilife Science · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K100761Biopro Polar HeadBiopro, Inc. · 2010 · cites it directly4descendants
- 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 · 2 generations on0descendants
- K171156OMNI Anseris Hip StemOmnilife Science · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953510 | Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis | Encore Orthopedics, Inc. | 1995 | 18 |
| −1 | K982447 | Plus Bipolar Prosthesis Cocrmo | Plus Orthopedics | 1998 | — |
| 0 (this device) | K082705 | Biopro Bipolar Head, Models 18130-18152 | Biopro, Inc. | 2008 | — |
| +1 | K100761 | Biopro Polar Head | Biopro, Inc. | 2010 | 1 |
| +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 | — |
| +2 | K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K171156 | OMNI Anseris Hip Stem | Omnilife Science | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K050966 | Pivot Bipolar Femoral HeadSummary page 2…t Pivot PLUS Bipolar Bipolar Head Prosthesis 510(k) Number Pending K050966 K982447 FDA Product Code KWY KWY KWY DESIGN Head-Liner-She… | 2005 |
| * | K982447 | Plus Bipolar Prosthesis CocrmoSummary page 2…icate Device Comparison Substantial equivalence is claimed to the Pivot Bipolar Femoral Head (K882146) distributed by Ortho Development and the PLUS Bipolar Prosthesis (K982447) distributed by Plus Orthopaedics (now Smith & Nephew). The following table summarizes the similarities and differences between t… | 1998 |
What descends from it? (7)
4 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 13 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K100761 (Biopro, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K050966.
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. 2008, 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 Hip System femoral stem for uncemented primary or revision arthroplasty 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/K082705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082705: Biopro Bipolar Head, Models 18130-18152.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082705
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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