510(k) · Cleared
ClearedCormet Cementless Resurfacing Femoral Head
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 Apr 15, 2010 as substantially equivalent to K994153 (Corin USA, 2000) and 1 other predicate after a 268-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Apr 15, 2010
- Review
- 268 days
- Class
- Class II
- Product code
- KXA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K983452 (1998). 6 ancestors in all, the oldest K811718 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK983452 Nelson Resurfacing HeadBiomet, Inc. · 1998
- 3 generations backK021799 Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc. · 2002
- 2 generations backK023188 Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002
- 1 generation backK071053 Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007
- This deviceK092198 Cormet Cementless Resurfacing Femoral HeadCorin USA · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983452 | Nelson Resurfacing Head | Biomet, Inc. | 1998 | — |
| −3 | K021799 | Cemented Femoral Head Resurfing Device | Biomet Orthopedics, Inc. | 2002 | — |
| −2 | K023188 | Press-Fit Head Resurfacing Device | Biomet Orthopedics, Inc. | 2002 | — |
| −1 | K071053 | Recap HA Press-Fit Femoral Resurfacing Head | Biomet, Inc. | 2007 | — |
| 0 (this device) | K092198 | Cormet Cementless Resurfacing Femoral Head | Corin USA | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K994153 | Cormet 2000 Hemi Hip Metallic Resurfacing ProsthesisSummary page 1…(21CFR 888.3400) 7. Legally Marketed Devices to which Substantial Equivalence is claimed: a. Cormiet 2000 Hemi Hip Metallic Resurfacing Prosthesis (K(994153) b. ReCap® HA Press-Fit Femoral Resurfacing Head (K(071053) 8. Device Description: The Cormet Cementle… | 2000 |
| * | K071053 | Recap HA Press-Fit Femoral Resurfacing HeadSummary page 1…Equivalence is claimed: a. Cormiet 2000 Hemi Hip Metallic Resurfacing Prosthesis (K(994153) b. ReCap® HA Press-Fit Femoral Resurfacing Head (K(071053) 8. Device Description: The Cormet Cementless Resurfacing Femoral Head is a femoral component manufactured f… | 2007 |
| † | K083312 | Minihip Stem | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K994153.
How does its category compare?
All KXA devicesKXA Prosthesis, Hip, Femoral, Resurfacing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
The Cormet Cementless Resurfacing Femoral Head is indicated for hemi hip resurfacing arthroplasty in patients with non-inflammatory degenerative joint disease, including osteo and rheumatoid arthritis, post traumatic disease and -avascular necrosis. It is indicated for relief of pain and disability, and to restore hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetzabulum, the bearing surface and…
Read the full statement (123 words)
The Cormet Cementless Resurfacing Femoral Head is indicated for hemi hip resurfacing arthroplasty in patients with non-inflammatory degenerative joint disease, including osteo and rheumatoid arthritis, post traumatic disease and -avascular necrosis.
It is indicated for relief of pain and disability, and to restore hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetzabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
It is intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as:
* previously failed femoral osteotomy, -
* early deformities of the proximal end of the femur.
The Cormet Cementless Resurfacing Femoral Head is indicated for cementiess use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092198: Cormet Cementless Resurfacing Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092198
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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