510(k) · Cleared
ClearedPress-Fit Head Resurfacing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · KXA Prosthesis, Hip, Femoral, Resurfacing
Cleared on Dec 11, 2002 as substantially equivalent to K021799 (Biomet Orthopedics, Inc., 2002) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1998. 7 later devices descend from it.
- Decided
- Dec 11, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- KXA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K983452 (1998). 3 ancestors in all, the oldest K811718 (1981). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK983452 Nelson Resurfacing HeadBiomet, Inc. · 1998
- 1 generation backK021799 Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc. · 2002
- This deviceK023188 Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK082673 Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008
- Descendant · 2 generations on · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
- Descendant · cites it directly · 1 of its ownK071053 Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK043542 Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082673Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008 · cites it directly2descendants
- K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · 2 generations on1descendant
- K071053Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007 · cites it directly1descendant
- K043542Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005 · cites it directly1descendant
- K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983452 | Nelson Resurfacing Head | Biomet, Inc. | 1998 | — |
| −1 | K021799 | Cemented Femoral Head Resurfing Device | Biomet Orthopedics, Inc. | 2002 | — |
| 0 (this device) | K023188 | Press-Fit Head Resurfacing Device | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K082673 | Conserve Pressfit Femoral Component | Wrightmedicaltechnologyinc | 2008 | — |
| +2 | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
| +1 | K071053 | Recap HA Press-Fit Femoral Resurfacing Head | Biomet, Inc. | 2007 | — |
| +1 | K043542 | Biopro Tara Femoral Resurfacing Component | Biopro, Inc. | 2005 | — |
| +3 | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021799 | Cemented Femoral Head Resurfing DeviceSummary page 1…mi-hip) metallic resurfacing prosthesis (21 CFR 888.3400) Legally Marketed Device to which Substantial Equivalence is claimed: Cemented Femoral Head Resurfacing Device (K021799), Conserve Head (K811008), TARA Head (K962514), Surface Replacement Hip Prostheses (K811718) Device Description: The Press-Fit H… | 2002 |
| Kept off the family tree | K811008 | Conserve Head Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ing prosthesis (21 CFR 888.3400) Legally Marketed Device to which Substantial Equivalence is claimed: Cemented Femoral Head Resurfacing Device (K021799), Conserve Head (K811008), TARA Head (K962514), Surface Replacement Hip Prostheses (K811718) Device Description: The Press-Fit Head Resurfacing device is… | |
| Kept off the family tree | K962514 | TARA Head Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…R 888.3400) Legally Marketed Device to which Substantial Equivalence is claimed: Cemented Femoral Head Resurfacing Device (K021799), Conserve Head (K811008), TARA Head (K962514), Surface Replacement Hip Prostheses (K811718) Device Description: The Press-Fit Head Resurfacing device is designed to replace… | |
| * | K811718 | Surface Replacement Hip ProsthesisSummary page 1…Substantial Equivalence is claimed: Cemented Femoral Head Resurfacing Device (K021799), Conserve Head (K811008), TARA Head (K962514), Surface Replacement Hip Prostheses (K811718) Device Description: The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while pr… | 1981 |
What descends from it? (7)
3 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082673 (Wrightmedicaltechnologyinc, 2008) has gone furthest, with 2 descendants of its own.
- 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.
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/K023188 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023188: Press-Fit Head Resurfacing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023188
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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