510(k) · Cleared
Recalled · Class II · 2025iNSitu Bipolar Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Companies, LLC · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Sep 17, 2019 as substantially equivalent to K082705 (Biopro, Inc., 2008) and 1 other predicate after a 126-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 17, 2019
- Review
- 126 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953510 (1995). 8 ancestors in all, the oldest K931655 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953510 Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented…Encore Orthopedics, Inc. · 1995 · Recalled
- 3 generations backK982447 Plus Bipolar Prosthesis CocrmoPlus Orthopedics · 1998
- 2 generations backK082705 Biopro Bipolar Head, Models 18130-18152Biopro, Inc. · 2008
- 1 generation backK100761 Biopro Polar HeadBiopro, Inc. · 2010 · Recalled
- This deviceK191297 iNSitu Bipolar Hip SystemTheken Companies, LLC · 2019
- Descendant · cites it directly · 0 of its ownK243192 iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with…Nextstep Arthopedix, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953510 | Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis | Encore Orthopedics, Inc. | 1995 | 18 |
| −3 | K982447 | Plus Bipolar Prosthesis Cocrmo | Plus Orthopedics | 1998 | — |
| −2 | K082705 | Biopro Bipolar Head, Models 18130-18152 | Biopro, Inc. | 2008 | — |
| −1 | K100761 | Biopro Polar Head | Biopro, Inc. | 2010 | 1 |
| 0 (this device) | K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | 2019 | — |
| +1 | K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed… | Nextstep Arthopedix, LLC | 2026 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K082705 | Biopro Bipolar Head, Models 18130-18152Summary page 4…87 (Orthopedic) 1.4 Legally Marketed Predicate NextStep Arthropedix is utilizing the BioPro Bipolar Head as a predicate device (K082705/K100761). The iNSitu Bipolar Hip System features component designs, materials, indications and manufacturing methods tha… | 2008 |
| * | K100761 | Biopro Polar HeadSummary page 4…87 (Orthopedic) 1.4 Legally Marketed Predicate NextStep Arthropedix is utilizing the BioPro Bipolar Head as a predicate device (K082705/K100761). The iNSitu Bipolar Hip System features component designs, materials, indications and manufacturing methods that are… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi… | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2025 | Class II | Z-0227-2026 | Package design/selection | Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K243192 (Nextstep Arthopedix, LLC, 2026) has gone furthest, with 0 descendants 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. 2019, 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 iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stems for uncemented primary or revision hemiarthroplasty 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;
• Revisions procedures where other devices or treatments for these indications have failed
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191297 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191297: iNSitu Bipolar Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191297
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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