510(k) · Cleared
ClearedRecap HA Press-Fit Femoral Resurfacing Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KXA Prosthesis, Hip, Femoral, Resurfacing
Cleared on Jun 29, 2007 as substantially equivalent to K023188 (Biomet Orthopedics, Inc., 2002) after a 77-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Jun 29, 2007
- Review
- 77 days
- Class
- Class II
- Product code
- KXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983452 (1998). 4 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 deviceK071053 Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK092198 Cormet Cementless Resurfacing Femoral HeadCorin USA · 2010
Most influential descendants
Showing 1 of 1 · See all- K092198Cormet Cementless Resurfacing Femoral HeadCorin USA · 2010 · 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) | K071053 | Recap HA Press-Fit Femoral Resurfacing Head | Biomet, Inc. | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K023188 | Press-Fit Head Resurfacing DeviceSummary page 1…urfacing prosthesis (21 CFR 888.3400) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Press-Fit Head resurfacing Device (K023188) Device Description: The ReCap® HA Press-Fit Femoral Resurfacing Head is a single- use, hemi-hip femoral resurfacing head, desig… | 2002 |
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 |
|---|---|---|---|
| K092198 | Cormet Cementless Resurfacing Femoral Head | 2010 | 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 9 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K092198 (Corin USA, 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K023188.
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?
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis.
The device is a single use implant intended for press-fit application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071053: Recap HA Press-Fit Femoral Resurfacing Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071053
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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