510(k) · Cleared

Cleared

Arcos One-piece Femoral Revision System

K151603510(k) TraditionalCleared Oct 6, 2015116-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 Oct 6, 2015 as substantially equivalent to K090757 (Biomet, Inc., 2009) and 1 other predicate after a 116-day review. Its family tree reaches back 6 generations to 1994.

Decided: Oct 6, 2015
Review: 116 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 2

Its longest line of descent runs back 6 generations to K921308 (1994). 25 ancestors in all, the oldest K921274 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
5 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
4 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
3 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
2 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
1 generation backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
This deviceK151603 Arcos One-piece Femoral Revision SystemBiomet, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K921308	HG Multilock Hip Prosthesis W/ TI-Nidium	Zimmer, Inc.	1994	1
−5	K972893	Partnership Revision Femoral Stems	Howmedica Corp.	1997	—
−4	K983404	Type 3 Femoral Components	Howmedica Corp.	1998	1
−3	K013106	2 Piece Modular Hip Stem	Howmedica Osteonics Corp.	2002	37
−2	K022549	Restoration Modular System	Howmedica Osteonics Corp.	2002	3
−1	K090757	Biomet Modular Femoral Revision System	Biomet, Inc.	2009	18
0 (this device)	K151603	Arcos One-piece Femoral Revision System	Biomet, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	5	0
1996	3	0
1997	1	0
1999	1	0
2000	4	0
2002	1	0
2003	1	0
2005	1	0

FIG. 1 — Lineage of K151603, 1994–2015Source: 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? (2)

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
*	K090757	Biomet Modular Femoral Revision System Summary page 5 …er cemented or uncemented prosthesis (21 CFR 888.3390) Legally marketed device(s) to which equivalence is claimed:  K090757 Modular Femoral Revision System (Arcos) (Biomet)  K000760 Reach Femoral Component (Biomet) Reference De…	Biomet, Inc.	2009	18
*	K000760	Reach Femoral Component Summary page 5 …Legally marketed device(s) to which equivalence is claimed:  K090757 Modular Femoral Revision System (Arcos) (Biomet)  K000760 Reach Femoral Component (Biomet) Reference Devices: Labeling and Biocompatibility:  K143009 Echo Bi-Metric Microplasty Hi…	Biomet, Inc.	2000	—
†	K143009	Echo Bi-Metric Microplasty Hip System	Biomet, Inc.	2014	—
†	K150503	Echo Bi-Metric Microplasty Line Extension	Biomet, Inc.	2015	—
†	K070274	Echo BI-Metric Press-Fit Stems	Biomet Manufacturing Corp	2007	3

Also cleared against K090757: 6 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)

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 21 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
12 of the 25 ancestors have a recall of any class.
6 other devices also cite its predicate K090757.

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. 2015, this device’s year, is highlighted.

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?

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5. Revision procedures where other treatment or devices have failed.

The Arcos One-Piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151603 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151603: Arcos One-piece Femoral Revision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151603

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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