510(k) · Cleared
Recalled · Class II · 2025Klassic BiPolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Total Joint Orthopedics · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Jan 28, 2015 as substantially equivalent to K100761 (Biopro, Inc., 2010) and 2 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1981. It has been recalled once.
- Decided
- Jan 28, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 9 generations to K810258 (1981). 84 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- This deviceK143113 Klassic BiPolar SystemTotal Joint Orthopedics · 2015
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- This deviceK143113 Klassic BiPolar SystemTotal Joint Orthopedics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −2 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −1 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| 0 (this device) | K143113 | Klassic BiPolar System | Total Joint Orthopedics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 10 | 0 |
| 1995 | 8 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100761 | Biopro Polar HeadSummary page 5…icTM BiPolar System System is substantially equivalent in intended use, design and function to the following primary predicate device: BioPro Bipolar Head – BioPro (K100761) BioPro Bipolar Femoral Head – BioPro (K082785) The KlassicTM BiPolar System is also substaintially equivalent in regards t… | 2010 |
| Kept off the family tree | K082785 | FDA’s K082785 is Nihon Kohden Bedside Monitor, BSM 9100A Series Our reading of the summary gave K082785, FDA’s number for Nihon Kohden Bedside Monitor, BSM 9100A Series (Nihon Kohden America, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BioPro Bipolar Femoral Head”. Kept off the family tree. Summary page 5…nt in intended use, design and function to the following primary predicate device: BioPro Bipolar Head – BioPro (K100761) BioPro Bipolar Femoral Head – BioPro (K082785) The KlassicTM BiPolar System is also substaintially equivalent in regards to technology characteristics to Klassic HD Hip… | 2008 |
| * | K100445 | Klassic HD Hip SystemSummary page 5…082785) The KlassicTM BiPolar System is also substaintially equivalent in regards to technology characteristics to Klassic HD Hip System – Total Joint Orthopedics (K100445) Tandem BiPolar Hip System – Smith & Nephew (K823726) INTENDED USE The KlassicTM BiPolar System is intended for use in com… | 2010 |
| * | K823726 | Spectron Conversion Endoprosthesis CupSummary page 5…ly equivalent in regards to technology characteristics to Klassic HD Hip System – Total Joint Orthopedics (K100445) Tandem BiPolar Hip System – Smith & Nephew (K823726) INTENDED USE The KlassicTM BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for p… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2025 | Class II | Z-0432-2026 | Packaging | 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 34 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 84 ancestors have a recall of any class.
- 2 other devices also cite its predicate K100761.
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. 2015, 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 Klassic™ BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for primary or revision hemiarthroplasty of the hip, without the use of bone cement, for treatment of the following conditions:
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143113: Klassic BiPolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143113
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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