510(k) · Cleared

Cleared

Libertas – Taper Uncemented Femoral Stem

K183684510(k) TraditionalCleared Aug 23, 2019238-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

Maxx Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Aug 23, 2019 as substantially equivalent to K120030 (Biomet Manufacturing Corp, 2012) and 6 other predicates after a 238-day review. Its family tree reaches back 8 generations to 1985. 1 later device descends from it.

Decided: Aug 23, 2019
Review: 238 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 7

Its longest line of descent runs back 8 generations to K850055 (1985). 75 ancestors in all, the oldest K830313 (1983). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
7 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
6 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
5 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
4 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
3 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
2 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
1 generation backK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012
This deviceK183684 Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc. · 2019
Descendant · cites it directly · 0 of its ownK253171 Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all

K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K850055	Profile Femoral Hip	Depuy, Inc.	1985	—
−7	K961378	Delta Hip Prosthesis	Zimmer, Inc.	1996	4
−6	K992667	ZMR Hip System-Revision Taper	Zimmer, Inc.	1999	1
−5	K994286	ZMR Hip System-Porous Revision	Zimmer, Inc.	2000	11
−4	K032726	Zimmer M/L Taper Hip Prosthesis, 7711 Series	Zimmer, Inc.	2003	3
−3	K071723	Zimmer Porolock Mis Stem	Zimmer GmbH	2008	2
−2	K110400	Taperloc Complete Microplasty Stem	Biomet Manufacturing Corp	2011	—
−1	K120030	Taperloc Complete Size 4MM and XR 123	Biomet Manufacturing Corp	2012	—
0 (this device)	K183684	Libertas – Taper Uncemented Femoral Stem	Maxx Orthopedics, Inc.	2019	—
+1	K253171	Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)	Maxx Orthopedics, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	2	0
1986	1	0
1987	2	0
1988	2	0
1990	1	0
1991	1	0
1994	11	0
1995	3	0
1996	7	0
1997	6	0
1998	3	0
1999	4	0
2000	6	0
2001	2	0
2002	3	0
2003	4	0
2004	2	0
2005	2	0
2006	1	0
2007	1	0
2010	1	0
2011	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K183684, 1985–2026Source: 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 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? (7)

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
*	K120030	Taperloc Complete Size 4MM and XR 123 Summary page 4 …Manufacturer Trade name 510(k) device category K120030, K110400,…	Biomet Manufacturing Corp	2012	—
*	K110400	Taperloc Complete Microplasty Stem Summary page 4 …K120030, K110400, Taperloc® Complete Stems K103755, Biomet Manufac…	Biomet Manufacturing Corp	2011	—
*	K103755	Taperloc Complete, Size 5 and 6 Summary page 4 …K110400, Taperloc® Complete Stems K103755, Biomet Manufacturing Predicate device Taperloc® Complete Microplasty K1…	Biomet Manufacturing Corp	2011	—
*	K101086	Taperloc Complete Summary page 4 …erloc® Complete Stems K103755, Biomet Manufacturing Predicate device Taperloc® Complete Microplasty K101086, Corp., USA System K062994,…	Biomet, Inc.	2010	—
*	K062994	Lateralized Taperloc Microplasty Femoral Components Summary page 4 …Taperloc® Complete Microplasty K101086, Corp., USA System K062994, K043537,…	Biomet Manufacturing Corp	2007	—
*	K043537	Taperloc 12/14 Taper Femoral Components Summary page 4 …System K062994, K043537, K921301,…	Biomet, Inc.	2005	—
*	K921301	Taperloc Femoral Stem and Universal Acetabular Com Summary page 4 …K043537, K921301, K183684 Page 2 of 3…	Biomet, Inc.	1994	—
†	K180973	Libertas Hip Replacement System	Maxx Orthopedics, Inc.	2018	—
†	K172857	Latitud Hip Replacement System	Meril Healthcare Pvt., Ltd.	2018	—

Also cleared against K120030: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K253171	Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)	Maxx Orthopedics, Inc.	2026	0

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 34 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
14 of the 75 ancestors have a recall of any class.
Of its descendants, K253171 (Maxx Orthopedics, Inc., 2026) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K120030.

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 Libertas™ 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 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, post…

Read the full statement (151 words)

The Libertas™ 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

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, 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 nonunion, femoral neck and trochanteric fractures of the proximal femur.

NOTE:

• The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, uncemented use only.

• The Cemented stem is intended for cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K183684 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183684: Libertas – Taper Uncemented Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183684

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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