510(k) · Cleared
ClearedCormet 2000 Hemi Hip Metallic Resurfacing Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · KXA Prosthesis, Hip, Femoral, Resurfacing
Cleared on Feb 25, 2000 after a 79-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Feb 25, 2000
- Review
- 79 days
- Class
- Class II
- Product code
- KXA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK994153 Cormet 2000 Hemi Hip Metallic Resurfacing ProsthesisCorin USA · 2000
- Descendant · cites it directly · 1 of its ownK043542 Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK092198 Cormet Cementless Resurfacing Femoral HeadCorin USA · 2010
- Descendant · cites it directly · 0 of its ownK070292 Durom Hip Resurfacing System, Femoral ComponentsZimmer GmbH · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK021549 Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing SystemStd Mfg., Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K043542Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005 · cites it directly1descendant
- K092198Cormet Cementless Resurfacing Femoral HeadCorin USA · 2010 · cites it directly0descendants
- K070292Durom Hip Resurfacing System, Femoral ComponentsZimmer GmbH · 2007 · cites it directly0descendants
- K021549Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing SystemStd Mfg., Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994153 | Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis | Corin USA | 2000 | — |
| +1 | K043542 | Biopro Tara Femoral Resurfacing Component | Biopro, Inc. | 2005 | — |
| +1 | K092198 | Cormet Cementless Resurfacing Femoral Head | Corin USA | 2010 | — |
| +1 | K070292 | Durom Hip Resurfacing System, Femoral Components | Zimmer GmbH | 2007 | 3 |
| +1 | K021549 | Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System | Std Mfg., Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 KXA? 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 KXA device
- #1 K201219 Biocore9 Femoral Head Resurfacing Componentscore 0.7 · 1 generation · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
4 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?
- Of its descendants, K043542 (Biopro, Inc., 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KXA devicesKXA Prosthesis, Hip, Femoral, Resurfacing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXA
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KXA
Too few KXA 510(k)s in any year since 2007 to give a median.
Recalls per year · KXA
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXA
14in 2025
MAUDE reports naming product code KXA, 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 | — | 2 | 15 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 1 | — | 13 | 68 |
| 2011 | 0 | — | 0 | 593 |
| 2012 | 0 | — | 1 | 2,099 |
| 2013 | 0 | — | 0 | 2,522 |
| 2014 | 0 | — | 0 | 2,431 |
| 2015 | 0 | — | 0 | 1,674 |
| 2016 | 0 | — | 0 | 621 |
| 2017 | 0 | — | 0 | 580 |
| 2018 | 0 | — | 0 | 430 |
| 2019 | 0 | — | 0 | 971 |
| 2020 | 0 | — | 0 | 373 |
| 2021 | 1 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Relief of pain and disability, and restoration of hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
This prosthesis is also intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as previously failed femoral osteotomy, previous fracture, or early deformities of the proximal end of the femur. These make it anatomically impossible to use a conventional femoral component. As above the acetabulum should be essentially normal.
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/K994153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994153: Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994153
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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