510(k) · Cleared
ClearedApex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnlife Science · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on May 28, 2010 as substantially equivalent to K082468 (Omni Life Science, Inc., 2009) and 2 other predicates after a 129-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- May 28, 2010
- Review
- 129 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K953510 (1995). 5 ancestors in all, the oldest K931655 (1994). 4 later devices descend from it, 2 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 backK082468 Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in…Omni Life Science, Inc. · 2009 · Recalled
- This deviceK100151 Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM)…Omnlife Science · 2010
- Descendant · cites it directly · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · 3 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK171156 OMNI Anseris Hip StemOmnilife Science · 2017
Most influential descendants
Showing 4 of 4 · See all- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · cites it directly2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 2 generations on1descendant
- K261576Icona Hip StemCorin, Ltd. · 2026 · 3 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 |
|---|---|---|---|---|---|
| −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 | K082468 | Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM]… | Omni Life Science, Inc. | 2009 | 23 |
| 0 (this device) | K100151 | Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44… | Omnlife Science | 2010 | — |
| +1 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +2 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +3 | K261576 | Icona Hip Stem | Corin, Ltd. | 2026 | — |
| +1 | K171156 | OMNI Anseris Hip Stem | Omnilife Science | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082468 | Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD…Summary page 1…Orthopedic (OR) Regulatory Class Class 11per 21 CFR §888.3390 Product Code KWY Legally Marketed Apex Hip System Bipolar Head Predicate Device(s) K 082468, K945793, K931655 Device Description The Apex Hip System Bipolar Head consists of a factory assembled Ultra High… | 2009 |
| * | K945793 | P.F.C.(R) Bipolar Hip System - 22MM BipolarSummary page 1…(OR) Regulatory Class Class 11per 21 CFR §888.3390 Product Code KWY Legally Marketed Apex Hip System Bipolar Head Predicate Device(s) K 082468, K945793, K931655 Device Description The Apex Hip System Bipolar Head consists of a factory assembled Ultra High… | 1995 |
| * | K931655 | P.F.C. Bipolar Hip SystemSummary page 1…ulatory Class Class 11per 21 CFR §888.3390 Product Code KWY Legally Marketed Apex Hip System Bipolar Head Predicate Device(s) K 082468, K945793, K931655 Device Description The Apex Hip System Bipolar Head consists of a factory assembled Ultra High Molecul… | 1994 |
What descends from it? (4)
2 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 15 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K201657 (Corin, Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K082468.
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 Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented 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/K100151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100151: Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100151
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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