510(k) · Cleared
ClearedCorin Optimom 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 Aug 4, 2011 as substantially equivalent to K063791 (Corin USA, 2007) and 3 other predicates after a 30-day review. Its family tree reaches back 11 generations to 1981. 62 later devices descend from it.
- Decided
- Aug 4, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K810258 (1981). 101 ancestors in all. 62 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 2 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 1 generation backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- This deviceK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · cites it directly · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 2 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- Descendant · 3 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 4 generations on · 26 of its ownK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 4 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 3 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 2 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 1 generation backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- This deviceK111911 Corin Optimom Modular HeadCorin USA · 2011
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · cites it directly61descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 2 generations on48descendants
- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 3 generations on38descendants
- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · 3 generations on27descendants
- K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016 · 4 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −4 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −3 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −2 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −1 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| 0 (this device) | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +1 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +2 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| +3 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| +3 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +4 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 12 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K063791 | Corin Unipolar Modular HeadSummary page 1…ted or uncemented prosthesis 6. Legally Marketed Devices to which Substantial Equivalence is claimed: * Corin Unipolar Modular Head (K(063791) * Corin Taperfit Total Hip System (K(003666) *Corin Tri-Fi… | 2007 |
| * | K003666 | Taper-Fit Total Hip SystemSummary page 1…quivalence is claimed: * Corin Unipolar Modular Head (K(063791) * Corin Taperfit Total Hip System (K(003666) *Corin Tri-Fit Femoral Stem (1(010243) *Corin Trinity Ace… | 2001 |
| * | K010243 | Tri-Fit Femoral StemSummary page 1…Modular Head (K(063791) * Corin Taperfit Total Hip System (K(003666) *Corin Tri-Fit Femoral Stem (1(010243) *Corin Trinity Acetabular System with HXLPE liners (K(1… | 2001 |
| * | K110087 | Corin Trinity Acetbular System with Hxlpe LinersSummary page 1…ensions of the internal female taper are substantially equivalent to the CoCr Modular Heads cleared in K(003666 and K(010243 and the Trinity Modular Heads cleared in K110087. The Optimom Modular Head is manufactured from Cobalt-Chrome alloy conforming to Page… | 2011 |
What descends from it? (62)
See all 621 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | 2012 | 61 |
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 30 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 26 of the 100 ancestors have a recall of any class.
- Of its descendants, K120362 (Corin USA, 2012) has gone furthest, with 61 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. 2011, 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 Optimom 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/K111911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111911: Corin Optimom 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/K111911
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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