510(k) · Cleared

Cleared

Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads

K112158510(k) TraditionalCleared May 10, 2012288-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

Lima Corporate S.P.A. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on May 10, 2012 as substantially equivalent to K000521 (Encore Orthopedics, Inc., 2000) and 15 other predicates after a 288-day review. Its family tree reaches back 7 generations to 1994. 1 of the 81 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.

Decided: May 10, 2012
Review: 288 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 16

Its longest line of descent runs back 7 generations to K921308 (1994). 67 ancestors in all, the oldest K850055 (1985). 13 later devices descend from it, 6 citing it directly. 1 of the 81 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 7 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
6 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
5 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
4 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
3 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
2 generations backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
1 generation backK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
This deviceK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
Descendant · cites it directly · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
Descendant · cites it directly · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
Descendant · cites it directly · 4 of its ownK140975 Mastersl Femoral StemLima Corporate S.P.A. · 2014
Descendant · cites it directly · 3 of its ownK191374 Revival Modular Hip StemCorin U.S.A. Limited · 2019
Descendant · 2 generations on · 3 of its ownK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2014high 2 (2014) · low 0 (2018)2026

Class I recalls in this family

K091423 Profemur Hip System Modular Necksdirect predicate · 2009

Most influential descendants

Showing 5 of 13 · See all

K141327Minima S SystemLima Corporate S.P.A. · 2014 · cites it directly5descendants
K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · cites it directly4descendants
K140975Mastersl Femoral StemLima Corporate S.P.A. · 2014 · cites it directly4descendants
K191374Revival Modular Hip StemCorin U.S.A. Limited · 2019 · cites it directly3descendants
K143509MasterSL femoral stemLima Corporate S.P.A. · 2015 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K921308	HG Multilock Hip Prosthesis W/ TI-Nidium	Zimmer, Inc.	1994	1
−6	K972893	Partnership Revision Femoral Stems	Howmedica Corp.	1997	—
−5	K983404	Type 3 Femoral Components	Howmedica Corp.	1998	1
−4	K013106	2 Piece Modular Hip Stem	Howmedica Osteonics Corp.	2002	37
−3	K022549	Restoration Modular System	Howmedica Osteonics Corp.	2002	3
−2	K090757	Biomet Modular Femoral Revision System	Biomet, Inc.	2009	18
−1	K092331	Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…	Encore Medical L.P.	2010	1
0 (this device)	K112158	Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock…	Lima Corporate S.P.A.	2012	—
+1	K141327	Minima S System	Lima Corporate S.P.A.	2014	—
+1	K152903	REVIVAL (TM) Modular Revision Hip Stem	Corin USA	2016	—
+1	K140975	Mastersl Femoral Stem	Lima Corporate S.P.A.	2014	—
+1	K191374	Revival Modular Hip Stem	Corin U.S.A. Limited	2019	—
+2	K143509	MasterSL femoral stem	Lima Corporate S.P.A.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1986	1	0
1987	1	0
1988	1	0
1990	2	0
1992	1	0
1994	5	0
1995	9	0
1996	5	0
1997	6	0
1998	4	0
1999	3	0
2000	7	0
2002	2	0
2003	8	0
2004	1	0
2005	1	0
2007	1	0
2009	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2015	2	0
2016	2	0
2017	1	0
2019	1	0
2021	1	0
2023	1	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K112158, 1994–2026Source: 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.

1 device in this family has a Class I recall. 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? (16)

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
*	K000521	Keystone Hip Summary page 3 …cetabular socket needs reconstruction. The DJO FMP acetabular cups are intended for press-fit (uncemented) use. Predicate Devices: Keystone Hip (Encore Medical, L.P., K00052 1) PROFEMUR R femoral system (Wright Medical Technology, K041 114-K091423) WAGNER CONE stem (Centerpulse orthopaedics, K032380). Mo…	Encore Orthopedics, Inc.	2000	—
*	K041114	Profemur Tapered Hip Stem Summary page 3 …ups are intended for press-fit (uncemented) use. Predicate Devices: Keystone Hip (Encore Medical, L.P., K00052 1) PROFEMUR R femoral system (Wright Medical Technology, K041 114-K091423) WAGNER CONE stem (Centerpulse orthopaedics, K032380). Modular Revision Hip Stem (Encore Medical, L.P., K09233 1) Articul…	Wrightmedicaltechnologyinc	2004	—
*	K091423	Profemur Hip System Modular Necks Summary page 3 …ntended for press-fit (uncemented) use. Predicate Devices: Keystone Hip (Encore Medical, L.P., K00052 1) PROFEMUR R femoral system (Wright Medical Technology, K041 114-K091423) WAGNER CONE stem (Centerpulse orthopaedics, K032380). Modular Revision Hip Stem (Encore Medical, L.P., K09233 1) Articul/eze fem…	Wrightmedicaltechnologyinc	2009	Class I
*	K032380	Wagner Cone Prosthesis Summary page 3 …evices: Keystone Hip (Encore Medical, L.P., K00052 1) PROFEMUR R femoral system (Wright Medical Technology, K041 114-K091423) WAGNER CONE stem (Centerpulse orthopaedics, K032380). Modular Revision Hip Stem (Encore Medical, L.P., K09233 1) Articul/eze femoral heads (Depuy, K883460-K9805 13) PE-Plus acetabul…	Centerpulse Orthopedics, Inc.	2003	—
*	K092331	Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; Summary page 3 …MUR R femoral system (Wright Medical Technology, K041 114-K091423) WAGNER CONE stem (Centerpulse orthopaedics, K032380). Modular Revision Hip Stem (Encore Medical, L.P., K09233 1) Articul/eze femoral heads (Depuy, K883460-K9805 13) PE-Plus acetabular cups (Plus Orthopaedics, K992153) ZCA All Poly Acetabular…	Encore Medical L.P.	2010	1
*	K883460	Focus Total Hip System Summary page 3 …ogy, K041 114-K091423) WAGNER CONE stem (Centerpulse orthopaedics, K032380). Modular Revision Hip Stem (Encore Medical, L.P., K09233 1) Articul/eze femoral heads (Depuy, K883460-K9805 13) PE-Plus acetabular cups (Plus Orthopaedics, K992153) ZCA All Poly Acetabular Cup (K030 153) Global Bipolar system (Smit…	Depuy, Inc.	1988	—
*	K980513	Articul/Eze Femoral Heads Summary page 3 …1 114-K091423) WAGNER CONE stem (Centerpulse orthopaedics, K032380). Modular Revision Hip Stem (Encore Medical, L.P., K09233 1) Articul/eze femoral heads (Depuy, K883460-K9805 13) PE-Plus acetabular cups (Plus Orthopaedics, K992153) ZCA All Poly Acetabular Cup (K030 153) Global Bipolar system (Smith & Nephe…	DePuy Orthopaedics, Inc.	1998	—
*	K992153	PE-Plus Acetabular Cup Summary page 3 …ics, K032380). Modular Revision Hip Stem (Encore Medical, L.P., K09233 1) Articul/eze femoral heads (Depuy, K883460-K9805 13) PE-Plus acetabular cups (Plus Orthopaedics, K992153) ZCA All Poly Acetabular Cup (K030 153) Global Bipolar system (Smith & Nephew, K023743) Bipolar (Encore Orthopedics Inc. K9535 10…	Plus Orthopedics	1999	—
*	K030153	Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32 Summary page 3 …em (Encore Medical, L.P., K09233 1) Articul/eze femoral heads (Depuy, K883460-K9805 13) PE-Plus acetabular cups (Plus Orthopaedics, K992153) ZCA All Poly Acetabular Cup (K030 153) Global Bipolar system (Smith & Nephew, K023743) Bipolar (Encore Orthopedics Inc. K9535 10) Foundation porous coated hemispherica…	Zimmer, Inc.	2003	—
*	K023743	Smith & Nephew Global Bipolar System Summary page 3 …emoral heads (Depuy, K883460-K9805 13) PE-Plus acetabular cups (Plus Orthopaedics, K992153) ZCA All Poly Acetabular Cup (K030 153) Global Bipolar system (Smith & Nephew, K023743) Bipolar (Encore Orthopedics Inc. K9535 10) Foundation porous coated hemispherical shell (Encore Orthopedics, Inc., K974093) Foun…	Smith & Nephew, Inc.	2003	3
*	K953510	Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis Summary page 3 …Plus acetabular cups (Plus Orthopaedics, K992153) ZCA All Poly Acetabular Cup (K030 153) Global Bipolar system (Smith & Nephew, K023743) Bipolar (Encore Orthopedics Inc. K9535 10) Foundation porous coated hemispherical shell (Encore Orthopedics, Inc., K974093) Foundation porous coated flared rim shell (Enco…	Encore Orthopedics, Inc.	1995	18
*	K974093	Foundation Porous Coated Hemispherical Shell Summary page 2 …50-58 mm with increments of 2 mm The Modulus femoral prostheses and modular CoCrMo heads are also compatible with the DJO EMP acetabular cups, previously cleared in K974093, K974095, K9731 19, K023794 and K072154. Lock Bipolar Heads are modular prostheses characterized by an external shell made fr…	Encore Orthopedics, Inc.	1998	—
*	K974095	Foundation Porous Coated Flared Rim Shell Summary page 2 …m with increments of 2 mm The Modulus femoral prostheses and modular CoCrMo heads are also compatible with the DJO EMP acetabular cups, previously cleared in K974093, K974095, K9731 19, K023794 and K072154. Lock Bipolar Heads are modular prostheses characterized by an external shell made from CoCrMo…	Encore Orthopedics, Inc.	1998	—
*	K973119	Foundation Porous Acetabular System Summary page 2 …crements of 2 mm The Modulus femoral prostheses and modular CoCrMo heads are also compatible with the DJO EMP acetabular cups, previously cleared in K974093, K974095, K9731 19, K023794 and K072154. Lock Bipolar Heads are modular prostheses characterized by an external shell made from CoCrMo (ASTM F15…	Encore Orthopedics, Inc.	1998	—
*	K023794	Constrained Liner Summary page 2 …2 mm The Modulus femoral prostheses and modular CoCrMo heads are also compatible with the DJO EMP acetabular cups, previously cleared in K974093, K974095, K9731 19, K023794 and K072154. Lock Bipolar Heads are modular prostheses characterized by an external shell made from CoCrMo (ASTM F1537) and by…	Encore Medical L.P.	2003	—
*	K072154	Foundation (FMP) Porous Coated Spiked Acetabular System Summary page 2 …Modulus femoral prostheses and modular CoCrMo heads are also compatible with the DJO EMP acetabular cups, previously cleared in K974093, K974095, K9731 19, K023794 and K072154. Lock Bipolar Heads are modular prostheses characterized by an external shell made from CoCrMo (ASTM F1537) and by a conical l…	Encore Medical L.P.	2007	1

Also cleared against K000521: 1 other device →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K141327	Minima S System	Lima Corporate S.P.A.	2014	5
K152903	REVIVAL (TM) Modular Revision Hip Stem	Corin USA	2016	4
K140975	Mastersl Femoral Stem	Lima Corporate S.P.A.	2014	4
K191374	Revival Modular Hip Stem	Corin U.S.A. Limited	2019	3
K150855	H-MAX S Femoral Hip System	Lima Corporate S.P.A.	2015	2
K243809	Biolox® Delta Revision heads	Limacorporate	2025	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
23 of the 67 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K141327 (Lima Corporate S.P.A., 2014) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K000521.

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. 2012, 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?

The MODULUS stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Modulus Stems are intended for use with Co-Cr-Mo femoral heads and a compatible acetabular cup. When used in partial hip arthroplasty, the Modulus Stems are intended for use with the Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip…

Read the full statement (137 words)

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

* non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;

* rheumatoid arthritis;

* osteoarthritis after femoral heads fractures;

* correction of functional deformity;

* revisions in cases of good remaining femoral bone stock.

The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112158 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112158

Report an extraction error

Are you the manufacturer?

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