510(k) · Cleared

Cleared

Arcom Polyethylene Acetabular Liners & Components

K926107510(k) TraditionalCleared Jul 28, 1993237-day reviewClass II21 CFR 888.3358

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 Jul 28, 1993 after a 237-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 481 later devices descend from it.

Decided: Jul 28, 1993
Review: 237 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 0

481 later devices descend from it, 2 citing it directly.

This deviceK926107 Arcom Polyethylene Acetabular Liners & ComponentsBiomet, Inc. · 1993
Descendant · cites it directly · 480 of its ownK023357 Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002 · Recalled
Descendant · 2 generations on · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
Descendant · 3 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
Descendant · 4 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
Descendant · 2 generations on · 289 of its ownK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005

Showing 5 of 481 descendants. See all descendants

Descendants cleared per year

2002high 38 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 481 · See all

K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002 · cites it directly480descendants
K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · 2 generations on355descendants
K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 3 generations on344descendants
K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 4 generations on343descendants
K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005 · 2 generations on289descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K926107	Arcom Polyethylene Acetabular Liners & Components	Biomet, Inc.	1993	—
+1	K023357	Arcpm 1050 Resin-Hips	Biomet Orthopedics, Inc.	2002	1
+2	K042051	Arcomxl Polyethylene Liners	Biomet, Inc.	2005	1
+3	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
+4	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
+2	K050327	E-Poly (Vitamin E) Acetabular Liners	Biomet, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	5	0
2006	2	0
2007	4	0
2008	3	0
2009	6	0
2010	6	0
2011	12	0
2012	19	0
2013	30	0
2014	29	0
2015	22	0
2016	26	0
2017	21	0
2018	26	0
2019	34	0
2020	32	0
2021	31	0
2022	34	0
2023	32	0
2024	34	0
2025	38	0
2026	34	0

FIG. 1 — Lineage of K926107, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (481)

See all 481

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

Number	Device	Applicant	Decided	Descendants
K023357	Arcpm 1050 Resin-Hips	Biomet Orthopedics, Inc.	2002	480
K042989	RX90 Low Profile Acetabular System	Biomet, Inc.	2005	1

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, K023357 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 480 descendants of its own.

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	—

https://510kreport.com/device/K926107 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926107: Arcom Polyethylene Acetabular Liners & Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926107

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026