510(k) · Cleared
Recalled · 2007Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Aug 9, 1995 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it. It has been recalled 18 times.
- Decided
- Aug 9, 1995
- Review
- 14 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 18
- Predicates
- 0
48 later devices descend from it, 3 citing it directly.
- This deviceK953510 Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented…Encore Orthopedics, Inc. · 1995
- Descendant · cites it directly · 36 of its ownK982447 Plus Bipolar Prosthesis CocrmoPlus Orthopedics · 1998
- Descendant · 2 generations on · 21 of its ownK082468 Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in…Omni Life Science, Inc. · 2009 · Recalled
- Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 11 of its ownK060707 Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK091967 Medacta Bipolar HeadMedacta International S.A. · 2010
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K982447Plus Bipolar Prosthesis CocrmoPlus Orthopedics · 1998 · cites it directly36descendants
- K082468Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD…Omni Life Science, Inc. · 2009 · 2 generations on21descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
- K060707Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006 · 2 generations on11descendants
- K091967Medacta Bipolar HeadMedacta International S.A. · 2010 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953510 | Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis | Encore Orthopedics, Inc. | 1995 | — |
| +1 | K982447 | Plus Bipolar Prosthesis Cocrmo | Plus Orthopedics | 1998 | — |
| +2 | K082468 | Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM]… | Omni Life Science, Inc. | 2009 | 23 |
| +1 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K060707 | Aesculap Bipolar Acetabular Cup | Aesculap, Inc. | 2006 | — |
| +2 | K091967 | Medacta Bipolar Head | Medacta International S.A. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (48)
See all 483 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2007 | Not classified | Z-0082-2008 | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0083-2008 | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0084-2008 | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0085-2008 | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0088-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0090-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0091-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0094-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0095-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0096-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0097-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0099-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0086-2008 | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0089-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0093-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0098-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0087-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Aug 2, 2007 | Not classified | Z-0092-2008 | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982447 (Plus Orthopedics, 1998) has gone furthest, with 36 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K953510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953510: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953510
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026