510(k) · Cleared

Recalled · Class II · 2014

Foundation (FMP) Porous Coated Spiked Acetabular System

K072154510(k) TraditionalCleared Dec 14, 2007133-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

Encore Medical L.P. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Dec 14, 2007 as substantially equivalent to K974093 (Encore Orthopedics, Inc., 1998) and 3 other predicates after a 133-day review. Its family tree reaches back 1 generation to 1997. 61 later devices descend from it. It has been recalled once.

Decided: Dec 14, 2007
Review: 133 days
Class: Class II
Product code: LPH
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K973302 (1997). 4 ancestors in all. 61 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK973302 Foundation Porous Hip StemEncore Orthopedics, Inc. · 1997
This deviceK072154 Foundation (FMP) Porous Coated Spiked Acetabular SystemEncore Medical L.P. · 2007
Descendant · cites it directly · 38 of its ownK130365 X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013
Descendant · 2 generations on · 21 of its ownK141006 RSP Humeral Socket InsertDjo Global · 2014 · Recalled
Descendant · 3 generations on · 18 of its ownK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
Descendant · 4 generations on · 15 of its ownK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2012high 8 (2025) · low 1 (2013)2026

Most influential descendants

Showing 5 of 61 · See all

K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013 · cites it directly38descendants
K141006RSP Humeral Socket InsertDjo Global · 2014 · 2 generations on21descendants
K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P. · 2017 · 3 generations on18descendants
K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019 · 4 generations on15descendants
K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973302	Foundation Porous Hip Stem	Encore Orthopedics, Inc.	1997	—
0 (this device)	K072154	Foundation (FMP) Porous Coated Spiked Acetabular System	Encore Medical L.P.	2007	—
+1	K130365	X-Alt Highly Cross Linked VE Acetabular Liner	Encore Medical L.P.	2013	—
+2	K141006	RSP Humeral Socket Insert	Djo Global	2014	2
+3	K172351	AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate…	Encore Medical L.P.	2017	3
+4	K190290	AltiVate Reverse Humeral Stem, 48mm	Encore Medical L.P.	2019	—
+1	K112158	Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock…	Lima Corporate S.P.A.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2013	1	0
2014	6	0
2015	2	0
2016	3	0
2017	3	0
2018	4	0
2019	6	0
2020	4	0
2021	5	0
2022	5	0
2023	6	0
2024	3	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K072154, 1997–2026Source: 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

Get a 510(k) Report

What was it cleared against? (4)

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
*	K974093	Foundation Porous Coated Hemispherical Shell Summary page 1 …Product Classification .Product Code Foundation® (FMPTM) Porous Coated Spiked Acetabular K974093, January 2$, 1998, Class II LPH System Foundation® (FMP T M ) Porous Coated Hemispherical K974095, Januar…	Encore Orthopedics, Inc.	1998	—
*	K974095	Foundation Porous Coated Flared Rim Shell Summary page 1 …PTM) Porous Coated Spiked Acetabular K974093, January 2$, 1998, Class II LPH System Foundation® (FMP T M ) Porous Coated Hemispherical K974095, January 28, 1998, Class 11 LPH Acetabular System Foundation® (FMP T M ) Porous Coated Flared Rim K973…	Encore Orthopedics, Inc.	1998	—
*	K973119	Foundation Porous Acetabular System Summary page 1 …ous Coated Hemispherical K974095, January 28, 1998, Class 11 LPH Acetabular System Foundation® (FMP T M ) Porous Coated Flared Rim K973119, January 28, 1998, Class 11 LPH Acetabular System Foundation® Press Fit (Porous Coated) Hip Stem K9733…	Encore Orthopedics, Inc.	1998	—
*	K973302	Foundation Porous Hip Stem Summary page 1 …rous Coated Flared Rim K973119, January 28, 1998, Class 11 LPH Acetabular System Foundation® Press Fit (Porous Coated) Hip Stem K973302 - December 2,1997, Class 11 LPH Product Code Regulation and Classification…	Encore Orthopedics, Inc.	1997	—

Also cleared against K974093: 6 other devices →

What descends from it? (61)

See all 61

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

Number	Device	Applicant	Decided	Descendants
K130365	X-Alt Highly Cross Linked VE Acetabular Liner	Encore Medical L.P.	2013	38
K112158	Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads	Lima Corporate S.P.A.	2012	13
K112898	Delta TT Cups, Delta TT Liners, Bone Screws	Lima Corporate S.P.A.	2012	12
K191708	Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head	Signature Orthopaedics Pty, Ltd.	2020	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 7, 2014	Class II	Z-1130-2014	Packaging process control	Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units…

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K130365 (Encore Medical L.P., 2013) has gone furthest, with 38 descendants of its own.
6 other devices also cite its predicate K974093.

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. 2007, 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?

Joint replacement is indicated for patients suffering from disability due to:

· noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the

natural femoral head;

· rheumatoid arthritis;

* correction of functional deformity;

* femoral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used

for cementless applications only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072154 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072154: Foundation (FMP) Porous Coated Spiked Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072154

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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