510(k) · Cleared

Recalled · Class II · 2019

HA X-Series BI-Metric Hip Femoral Components

K023409510(k) SpecialCleared Nov 8, 200229-day reviewClass II21 CFR 888.3358Recalls 1

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

Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Nov 8, 2002 as substantially equivalent to K020580 (Biomet, Inc., 2002) after a 29-day review. Its family tree reaches back 2 generations to 1994. It has been recalled once.

Decided: Nov 8, 2002
Review: 29 days
Class: Class II
Product code: LPH
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K921224 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK921224 Bimetric Total Hip SystemBiomet, Inc. · 1994
1 generation backK020580 X-Series BI-Metric Hip Femoral ComponentsBiomet, Inc. · 2002
This deviceK023409 HA X-Series BI-Metric Hip Femoral ComponentsBiomet, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K921224	Bimetric Total Hip System	Biomet, Inc.	1994	—
−1	K020580	X-Series BI-Metric Hip Femoral Components	Biomet, Inc.	2002	—
0 (this device)	K023409	HA X-Series BI-Metric Hip Femoral Components	Biomet, Inc.	2002	—

FIG. 1 — Lineage of K023409, 1994–2002Source: 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 LPH? 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 LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K020580	X-Series BI-Metric Hip Femoral Components Summary page 1 …rous- coated, uncemented prosthesis (21 C.F.R. 888.3358) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: X-Series Bi-Metria Hip Femoral Component (K020580) Device Description: The HA X-Series Bi-Metria Hip Femoral Components consist of the same design and materials as the predicate…	Biomet, Inc.	2002	—

Also cleared against K020580: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2019	Class II	Z-0523-2020	Environmental control	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 8.1 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K020580.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023409 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023409: HA X-Series BI-Metric Hip Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023409

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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