510(k) · Cleared

Cleared

Latitud Hip Replacement System

K183532510(k) TraditionalCleared Jul 18, 2019211-day reviewClass II21 CFR 888.3353

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

Meril Healthcare Pvt., Ltd. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jul 18, 2019 as substantially equivalent to K180973 (Maxx Orthopedics, Inc., 2018) and 10 other predicates after a 211-day review. Its family tree reaches back 14 generations to 1981.

Decided: Jul 18, 2019
Review: 211 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 11

Its longest line of descent runs back 14 generations to K810258 (1981). 201 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
10 generations between
3 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
2 generations backK172857 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
1 generation backK180973 Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018
This deviceK183532 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019

Show all 14 generations

Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
13 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
12 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
11 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
10 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
9 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
8 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
7 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
6 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
5 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
4 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
3 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
2 generations backK172857 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
1 generation backK180973 Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018
This deviceK183532 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−14	K810258	Proximal Fermoral Hip Replacement	Biomet, Inc.	1981	—
−13	K974558	Salvage/Onocology Hip and Total Femur System	Biomet, Inc.	1998	—
−12	K032396	Ringloc 36MM Line and Modular Femoral Heads	Biomet, Inc.	2003	3
−11	K042051	Arcomxl Polyethylene Liners	Biomet, Inc.	2005	1
−10	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
−9	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
−8	K071535	Biolox Delta Ceramic Femoral Head	Zimmer, Inc.	2007	3
−7	K082844	Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…	Encore Medical L.P.	2008	1
−6	K100412	Biolox Delta Ceramic Femoral Heads	Smith & Nephew, Inc.	2010	—
−5	K103120	Corin Biolox Delta Femoral Heads	Corin USA	2011	—
−4	K110087	Corin Trinity Acetbular System with Hxlpe Liners	Corin USA	2011	—
−3	K130343	Corin Trinity Acetabular System with Extra-Long Heads	Corin USA	2013	2
−2	K172857	Latitud Hip Replacement System	Meril Healthcare Pvt., Ltd.	2018	—
−1	K180973	Libertas Hip Replacement System	Maxx Orthopedics, Inc.	2018	—
0 (this device)	K183532	Latitud Hip Replacement System	Meril Healthcare Pvt., Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1984	1	0
1985	4	0
1986	1	0
1987	2	0
1988	2	0
1989	2	0
1990	2	0
1991	4	0
1992	4	0
1993	3	0
1994	22	0
1995	12	0
1996	17	0
1997	12	0
1998	9	0
1999	9	0
2000	19	0
2001	8	0
2002	11	0
2003	8	0
2004	8	0
2005	8	0
2006	4	0
2007	2	0
2008	1	0
2009	2	0
2010	2	0
2011	4	0
2012	2	0

FIG. 1 — Lineage of K183532, 1981–2019Source: 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 LZO? 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 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? (11)

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
*	K180973	Libertas Hip Replacement System Summary page 5 …5.5 Predicate Devices LatitudTM Hip Replacement System is utilizing the following devices to demonstrate substantial equivalence. Libertas – Hip Replacement System (K180973) is considered as the primary predicate (same Indications for use) and all other devices are included for performance comparison.…	Maxx Orthopedics, Inc.	2018	—
*	K110087	Corin Trinity Acetbular System with Hxlpe Liners Summary page 5 …Replacement System Trinity Acetabular cup Corin, USA K110087 System Marathon Acetabular DePuy Orthopaedi…	Corin USA	2011	—
*	K033273	Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima… Summary page 5 …System Marathon Acetabular DePuy Orthopaedics, Inc., USA K033273 Liner Ortho Development Corporation, Escalade Acetabular Cup…	DePuy Orthopaedics, Inc.	2004	—
*	K103384	Escalade Acetabular Cup System Summary page 5 …Liner Ortho Development Corporation, Escalade Acetabular Cup K103384 USA System K101086,…	Ortho Development	2011	1
*	K101086	Taperloc Complete Summary page 5 …K103384 USA System K101086, K062994, T…	Biomet, Inc.	2010	—
*	K062994	Lateralized Taperloc Microplasty Femoral Components Summary page 5 …System K101086, K062994, Taperloc® Complete…	Biomet Manufacturing Corp	2007	—
*	K103755	Taperloc Complete, Size 5 and 6 Summary page 5 …K062994, Taperloc® Complete K103755, Biomet Manufacturing Corp., Stems K120…	Biomet Manufacturing Corp	2011	—
*	K120030	Taperloc Complete Size 4MM and XR 123 Summary page 5 …K103755, Biomet Manufacturing Corp., Stems K120030, USA Taperloc® Complete…	Biomet Manufacturing Corp	2012	—
*	K043537	Taperloc 12/14 Taper Femoral Components Summary page 5 …K120030, USA Taperloc® Complete K043537, Microplasty System…	Biomet, Inc.	2005	—
*	K921301	Taperloc Femoral Stem and Universal Acetabular Com Summary page 5 …K043537, Microplasty System K921301, K110400 5.6 Device Description: LatitudTM Hip Repla…	Biomet, Inc.	1994	—
*	K110400	Taperloc Complete Microplasty Stem Summary page 5 …sty System K921301, K110400 5.6 Device Description: LatitudTM Hip Replacement System cleared under K172857 consists of modular acetabular cup system, femor…	Biomet Manufacturing Corp	2011	—

Also cleared against K180973: 2 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 38 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
47 of the 200 ancestors have a recall of any class.
2 other devices also cite its predicate K180973.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is an evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: • Non-inflammatory degenerative joint diseases including osteoarthritis…

Read the full statement (266 words)

Total hip replacement is indicated for the following conditions:

• Non-inflammatory degenerative joint diseases including osteoarthritis, post-traumatic arthritis and avascular necrosis.

• Rheumatoid arthritis.

• Congenital hip dysplasia.

• Acute traumatic fracture of the femoral head or neck.

• Certain cases of Ankylosis.

• Dislocation of the hip.

• Correction of functional deformity.

• Revision of failed joint reconstruction or treatment.

• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.

Note:

• The Titanium coated Modular Acetabular Shell is intended for press-fit, uncemented use only.

• The Hydroxyapatite coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.

• The Proximally coated Uncemented femoral stem is intended for press-fit, uncemented use only.

• The Cemented Femoral stem is intended for cemented use only.

• The Modular Acetabular Liner is intended for use with Modular Acetabular Shell.

• The CoCr Modular Femoral Head is intended to articulate with Modular Acetabular Liner to mate with uncemented stem or cemented stem.

• The Biolox® delta Modular Femoral Head is intended to articulate with Modular Acetabular Liner and to mate with uncemented stem or cemented stem.

• The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.

• The Centralizer and Cement Restrictor are intended for use with cemented stem only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K183532 · printed Nov 4, 2026

Cite this page

510(k) Report. “K183532: Latitud Hip Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183532

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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