510(k) · Cleared
ClearedBiopro Tara Femoral Resurfacing Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopro, Inc. · KXA Prosthesis, Hip, Femoral, Resurfacing
Cleared on May 18, 2005 as substantially equivalent to K032659 (DePuy Orthopaedics, Inc., 2003) and 2 other predicates after a 146-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- May 18, 2005
- Review
- 146 days
- Class
- Class II
- Product code
- KXA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K983452 (1998). 6 ancestors in all, the oldest K811718 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK983452 Nelson Resurfacing HeadBiomet, Inc. · 1998
- 2 generations backK021799 Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc. · 2002
- 1 generation backK023188 Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002
- This deviceK043542 Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK070292 Durom Hip Resurfacing System, Femoral ComponentsZimmer GmbH · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K070292Durom Hip Resurfacing System, Femoral ComponentsZimmer GmbH · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983452 | Nelson Resurfacing Head | Biomet, Inc. | 1998 | — |
| −2 | K021799 | Cemented Femoral Head Resurfing Device | Biomet Orthopedics, Inc. | 2002 | — |
| −1 | K023188 | Press-Fit Head Resurfacing Device | Biomet Orthopedics, Inc. | 2002 | — |
| 0 (this device) | K043542 | Biopro Tara Femoral Resurfacing Component | Biopro, Inc. | 2005 | — |
| +1 | K070292 | Durom Hip Resurfacing System, Femoral Components | Zimmer GmbH | 2007 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K032659 | Depuy Asr Resurfacing Femoral HeadsSummary page 1…Hip, Femoral Resurfacing (see 21 CRF, Sec. 888.3400). DEVICE PRODUCT CODE: KXA SUBSTANTIALLY DePuy ASR Resurfacing Femoral Heads (K032659) EQUIVALENT DEVICES: Cormet 2000 Hemi Hip Metallic Resurfacing Prosth. (K994153) Biomet Press-Fit Hea… | 2003 |
| * | K994153 | Cormet 2000 Hemi Hip Metallic Resurfacing ProsthesisSummary page 1…CE PRODUCT CODE: KXA SUBSTANTIALLY DePuy ASR Resurfacing Femoral Heads (K032659) EQUIVALENT DEVICES: Cormet 2000 Hemi Hip Metallic Resurfacing Prosth. (K994153) Biomet Press-Fit Head Resurfacing Device (K023188) Wright Medical CONSERVE Femor… | 2000 |
| * | K023188 | Press-Fit Head Resurfacing DeviceSummary page 1…ral Heads (K032659) EQUIVALENT DEVICES: Cormet 2000 Hemi Hip Metallic Resurfacing Prosth. (K994153) Biomet Press-Fit Head Resurfacing Device (K023188) Wright Medical CONSERVE Femoral Surface Replacement DEVICE DESCRIPTION: The all-metal cobalt chrome… | 2002 |
| * | — | Wright Medical CONSERVE Femoral Surface Replacement Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070292 | Durom Hip Resurfacing System, Femoral Components | 2007 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K070292 (Zimmer GmbH, 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032659.
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?
Indications for use include a severe disabling and/or painful hip associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043542 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043542: Biopro Tara Femoral Resurfacing Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043542
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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