510(k) · Cleared
ClearedNelson 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 Dec 3, 1998 after a 64-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Dec 3, 1998
- Review
- 64 days
- Class
- Class II
- Product code
- KXA
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK983452 Nelson Resurfacing HeadBiomet, Inc. · 1998
- Descendant · cites it directly · 9 of its ownK021799 Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc. · 2002
- Descendant · 2 generations on · 7 of its ownK023188 Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002
- Descendant · 3 generations on · 2 of its ownK082673 Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008
- Descendant · 2 generations on · 2 of its ownK032659 Depuy Asr Resurfacing Femoral HeadsDePuy Orthopaedics, Inc. · 2003 · Recalled
- Descendant · 4 generations on · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K021799Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc. · 2002 · cites it directly9descendants
- K023188Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002 · 2 generations on7descendants
- K082673Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008 · 3 generations on2descendants
- K032659Depuy Asr Resurfacing Femoral HeadsDePuy Orthopaedics, Inc. · 2003 · 2 generations on2descendants
- K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983452 | Nelson Resurfacing Head | Biomet, Inc. | 1998 | — |
| +1 | K021799 | Cemented Femoral Head Resurfing Device | Biomet Orthopedics, Inc. | 2002 | — |
| +2 | K023188 | Press-Fit Head Resurfacing Device | Biomet Orthopedics, Inc. | 2002 | — |
| +3 | K082673 | Conserve Pressfit Femoral Component | Wrightmedicaltechnologyinc | 2008 | — |
| +2 | K032659 | Depuy Asr Resurfacing Femoral Heads | DePuy Orthopaedics, Inc. | 2003 | 13 |
| +4 | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | — | Converse Named without a submission number | |
| * | — | Ceramic TARA Femoral Resurfacing Component Named without a submission number | |
| * | — | Tharies Named without a submission number |
What descends from it? (11)
See all 112 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?
- Of its descendants, K021799 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 9 descendants of its own.
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?
a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
b.) rheumatoid arthritis
The Nelson Resurfacing Head is cemented femoral component and is a single use implant.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983452: Nelson Resurfacing Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983452
Report an extraction error
Are you the manufacturer?
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