510(k) · Cleared
Recalled · 2009Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omni Life Science, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Feb 18, 2009 as substantially equivalent to K982447 (Plus Orthopedics, 1998) after a 175-day review. Its family tree reaches back 2 generations to 1995. 21 later devices descend from it. It has been recalled 23 times.
- Decided
- Feb 18, 2009
- Review
- 175 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 23
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953510 (1995). 21 later devices descend from it, 6 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 deviceK082468 Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in…Omni Life Science, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK091967 Medacta Bipolar HeadMedacta International S.A. · 2010
- Descendant · 2 generations on · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
- Descendant · cites it directly · 4 of its ownK100761 Biopro Polar HeadBiopro, Inc. · 2010 · Recalled
- Descendant · cites it directly · 4 of its ownK100151 Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM)…Omnlife Science · 2010
- Descendant · cites it directly · 3 of its ownK183114 Corin BiPolar-iCorin U.S.A. Limited · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K091967Medacta Bipolar HeadMedacta International S.A. · 2010 · cites it directly9descendants
- K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · 2 generations on5descendants
- K100761Biopro Polar HeadBiopro, Inc. · 2010 · cites it directly4descendants
- K100151Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)Omnlife Science · 2010 · cites it directly4descendants
- K183114Corin BiPolar-iCorin U.S.A. Limited · 2019 · cites it directly3descendants
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) | K082468 | Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM]… | Omni Life Science, Inc. | 2009 | — |
| +1 | K091967 | Medacta Bipolar Head | Medacta International S.A. | 2010 | — |
| +2 | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… | Signature Orthopaedics Pty Limited | 2014 | — |
| +1 | K100761 | Biopro Polar Head | Biopro, Inc. | 2010 | 1 |
| +1 | K100151 | Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44… | Omnlife Science | 2010 | — |
| +1 | K183114 | Corin BiPolar-i | Corin U.S.A. Limited | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| Kept off the family tree | K050888 | FDA’s K050888 is Integra Immobilization System Our OCR of the scanned summary read K050888, FDA’s number for Integra Immobilization System (Diacor, Inc.), which shares no word with the summary’s name for the device, “Pivol Bipolar Femoral Head”, apart from generic ones like “system”. Kept off the family tree. | 2005 |
| * | K982447 | Plus Bipolar Prosthesis CocrmoSummary page 2…Predicate Device Comparison Substantial equivalence is claimed o the Pivol Bipoiar Femoral Head (KOS0888) distributed by Crtho Development, the PLUS Bipolar Prosthesis (K982447) distributed by Plus Crthopaedics {now Smith & Nephew), and the BioPro Bipolar Head (KOBZT05). The following table summanzes the… | 1998 |
| Kept off the family tree | K082705 | FDA’s K082705 is Biopro Bipolar Head, Models 18130-18152 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091967 | Medacta Bipolar Head | 2010 | 9 |
| K100761 | Biopro Polar Head | 2010 | 4 |
| K100151 | Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM) | 2010 | 4 |
| K183114 | Corin BiPolar-i | 2019 | 3 |
| K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell… | 2021 | 2 |
| K171156 | OMNI Anseris Hip Stem | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2009 | Not classified | Z-1972-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1984-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1986-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1975-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1969-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1977-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1987-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1973-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1983-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1978-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1985-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1967-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1980-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1968-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1971-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1976-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1966-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1982-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1981-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1974-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1970-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1979-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Jul 10, 2009 | Not classified | Z-1988-2009 | Device Design | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
The 5 latest of 23 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K091967 (Medacta International S.A., 2010) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K982447.
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. 2009, 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 Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem 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;
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/K082468 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082468
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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