510(k) · Cleared
Recalled · Class II · 2012Durom Hip Resurfacing System, Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · KXA Prosthesis, Hip, Femoral, Resurfacing
Cleared on Apr 26, 2007 as substantially equivalent to K021799 (Biomet Orthopedics, Inc., 2002) and 3 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1998. It has been recalled 3 times.
- Decided
- Apr 26, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- KXA
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 4 generations to K983452 (1998). 7 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 backK043542 Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005
- This deviceK070292 Durom Hip Resurfacing System, Femoral ComponentsZimmer GmbH · 2007
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 | K043542 | Biopro Tara Femoral Resurfacing Component | Biopro, Inc. | 2005 | — |
| 0 (this device) | K070292 | Durom Hip Resurfacing System, Femoral Components | Zimmer GmbH | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K021799 | Cemented Femoral Head Resurfing DeviceSummary page 1…edics/87/KXA Predicate Devices: Cemented Femoral Head Resurfacing Device, manufactured by Biomet Orthopedics, K02 1799, cleared June 26, 2002. DePuy ASRIm Resurfacing Fem… | 2002 |
| * | K032659 | Depuy Asr Resurfacing Femoral HeadsSummary page 1…d June 26, 2002. DePuy ASRIm Resurfacing Femoral Heads, manufactured by DePuy Orthopaedics, K032659, cleared December 4, 2003. BIOPRO TARA Femoral Resu… | 2003 |
| * | K043542 | Biopro Tara Femoral Resurfacing ComponentSummary page 1…December 4, 2003. BIOPRO TARA Femoral Resurfacing Component, manufactured by BioPro, Inc., K043542, cleared May 18, 2005. The Cormet 2000 Hemi Hip Met… | 2005 |
| * | K994153 | Cormet 2000 Hemi Hip Metallic Resurfacing ProsthesisSummary page 1…The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses, manufactured by Corin Medical, K994 153, cleared February 25, 2000. Device Description: The Durom®Hip Resurfacing System femoral… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0216-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 26, 2007 | Not classified | Z-0276-2008 | Packaging process control | Mislabeled as to size; 54mm package contains 46 mm device and vice versa. |
| Sep 26, 2007 | Not classified | Z-0275-2008 | Packaging process control | Mislabeled as to size; 54mm package contains 46 mm device and vice versa. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K021799.
How does its category compare?
All KXA devicesKXA Prosthesis, Hip, Femoral, Resurfacing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
FOR HEMI-HIP RESURFACING ARTHROPLASTY: The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and…
Read the full statement (234 words)
FOR HEMI-HIP RESURFACING ARTHROPLASTY:
The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65.
* Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if remaining bone stock is adequate, and osteoarthritis
* Inflammatory joint disease (IJD), e.g. rheumatoid arthritis
* Joint replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives
Additional indications include other abnormalities where major pathology affects the femoral head; where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable
* WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070292: Durom Hip Resurfacing System, Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070292
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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