510(k) · Cleared
ClearedCorin Unipolar Modular Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Apr 3, 2007 as substantially equivalent to K940190 (Johnson & Johnson Orthopaedics, Inc., 1994) and 3 other predicates after a 102-day review. Its family tree reaches back 1 generation to 1991. 63 later devices descend from it.
- Decided
- Apr 3, 2007
- Review
- 102 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K902365 (1991). 4 ancestors in all. 63 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK902365 Modular Unipolar SystemHowmedica Corp. · 1991
- This deviceK063791 Corin Unipolar Modular HeadCorin USA · 2007
- Descendant · cites it directly · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · 2 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 3 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- Descendant · 4 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K111911Corin Optimom Modular HeadCorin USA · 2011 · cites it directly62descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 2 generations on61descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 3 generations on48descendants
- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 4 generations on38descendants
- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · 4 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902365 | Modular Unipolar System | Howmedica Corp. | 1991 | — |
| 0 (this device) | K063791 | Corin Unipolar Modular Head | Corin USA | 2007 | — |
| +1 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +2 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +3 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| +4 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| +4 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 7 | 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 KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940190 | Ultima Unipolar Modular HeadSummary page 1…prosthesis (21CFR 888.3360) 6. Legally Marketed Devices to which Substantial Equivalence is claimed: a. Johnson &Johnson ULTIMA Unipolar Modular Heads (I<940190) b. Howmedica Unitrax Unipolar System (1<902365) c. Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeve (1K99257… | 1994 |
| * | K902365 | Modular Unipolar SystemSummary page 1…keted Devices to which Substantial Equivalence is claimed: a. Johnson &Johnson ULTIMA Unipolar Modular Heads (I<940190) b. Howmedica Unitrax Unipolar System (1<902365) c. Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeve (1K992570) d. Osteonics Ion Implanted Femoral Bearings (… | 1991 |
| * | K992570 | Unitrax C-Taper Neck Adjustment SleeveSummary page 1…ohnson ULTIMA Unipolar Modular Heads (I<940190) b. Howmedica Unitrax Unipolar System (1<902365) c. Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeve (1K992570) d. Osteonics Ion Implanted Femoral Bearings (1910988) 7. Device Description: The Corin Unipolar Modular Head is… | 1999 |
| * | K910988 | Osteonics Ion Implanted Femoral Bearing SeriesSummary page 1…edica Unitrax Unipolar System (1<902365) c. Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeve (1K992570) d. Osteonics Ion Implanted Femoral Bearings (1910988) 7. Device Description: The Corin Unipolar Modular Head is a polished, truncated sphere with a high tolerance… | 1991 |
What descends from it? (63)
See all 631 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111911 | Corin Optimom Modular Head | 2011 | 62 |
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?
- None of the 4 ancestors has a recall.
- Of its descendants, K111911 (Corin USA, 2011) has gone furthest, with 62 descendants of its own.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | 2 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063791: Corin Unipolar Modular Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063791
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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