510(k) · Cleared

Cleared

Cemented Femoral Head Resurfing Device

K021799510(k) SpecialCleared Jun 26, 200226-day reviewClass II21 CFR 888.3400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Orthopedics, Inc. · KXA Prosthesis, Hip, Femoral, Resurfacing

Cleared on Jun 26, 2002 as substantially equivalent to K983452 (Biomet, Inc., 1998) after a 26-day review. Its family tree reaches back 1 generation to 1998. 9 later devices descend from it.

Decided: Jun 26, 2002
Review: 26 days
Class: Class II
Product code: KXA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K983452 (1998). 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK983452 Nelson Resurfacing HeadBiomet, Inc. · 1998
This deviceK021799 Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc. · 2002
Descendant · cites it directly · 7 of its ownK023188 Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002
Descendant · 2 generations on · 2 of its ownK082673 Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008
Descendant · cites it directly · 2 of its ownK032659 Depuy Asr Resurfacing Femoral HeadsDePuy Orthopaedics, Inc. · 2003 · Recalled
Descendant · 3 generations on · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
Descendant · 2 generations on · 1 of its ownK071053 Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2002high 2 (2007) · low 0 (2004)2026

Most influential descendants

Showing 5 of 9 · See all

K023188Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002 · cites it directly7descendants
K082673Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008 · 2 generations on2descendants
K032659Depuy Asr Resurfacing Femoral HeadsDePuy Orthopaedics, Inc. · 2003 · cites it directly2descendants
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · 3 generations on1descendant
K071053Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983452	Nelson Resurfacing Head	Biomet, Inc.	1998	—
0 (this device)	K021799	Cemented Femoral Head Resurfing Device	Biomet Orthopedics, Inc.	2002	—
+1	K023188	Press-Fit Head Resurfacing Device	Biomet Orthopedics, Inc.	2002	—
+2	K082673	Conserve Pressfit Femoral Component	Wrightmedicaltechnologyinc	2008	—
+1	K032659	Depuy Asr Resurfacing Femoral Heads	DePuy Orthopaedics, Inc.	2003	13
+3	K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	—
+2	K071053	Recap HA Press-Fit Femoral Resurfacing Head	Biomet, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2005	1	0
2007	2	0
2008	1	0
2010	1	0
2018	1	0
2024	1	0

FIG. 1 — Lineage of K021799, 1998–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

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	Applicant	Decided	Recalls
*	K983452	Nelson Resurfacing Head Summary page 1 …CFR 888.3400) Legally Marketed Device to which Substantial Equivalence is claimed: The current device is a modification of the Nelson resurfacing Head cleared by 510(k) K983452. Device Description: The Cemented Femoral Head Resurfacing device is designed to replace the outer surface of the femoral head w…	Biomet, Inc.	1998	—

Also cleared against K983452: 1 other device →

What descends from it? (9)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023188	Press-Fit Head Resurfacing Device	Biomet Orthopedics, Inc.	2002	7
K032659	Depuy Asr Resurfacing Femoral Heads	DePuy Orthopaedics, Inc.	2003	2
K070292	Durom Hip Resurfacing System, Femoral Components	Zimmer GmbH	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?

Its one ancestor has no recall.
Of its descendants, K023188 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K983452.

How does its category compare?

All KXA devices

KXA Prosthesis, Hip, Femoral, Resurfacing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXA

1in 2021

2007high 2 (2007) · low 0 (2009)2026

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

2007high 13 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KXA

14in 2025

2007high 2,522 (2013) · low 2 (2024)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

Rheumatoid arthritis

The device is a single use implant intended for use with bone cement

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021799 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021799: Cemented Femoral Head Resurfing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021799

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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