510(k) · Cleared

Recalled · Class II · 2012

MS-30 Femoral Stem Standard and Lateral

K040803510(k) SpecialCleared Apr 29, 200431-day reviewClass II21 CFR 888.3353Recalls 2

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

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

Cleared on Apr 29, 2004 as substantially equivalent to K993043 (Sulzer Orthopedics, Inc., 1999) and 2 other predicates after a 31-day review. Its family tree reaches back 1 generation to 1999. 8 later devices descend from it. It has been recalled 2 times.

Decided: Apr 29, 2004
Review: 31 days
Class: Class II
Product code: LZO
Recalls: 2
Predicates: 3

Its longest line of descent runs back 1 generation to K993043 (1999). 3 ancestors in all. 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK993043 MS-30 Femoral StemSulzer Orthopedics, Inc. · 1999
This deviceK040803 MS-30 Femoral Stem Standard and LateralZimmer, Inc. · 2004
Descendant · cites it directly · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
Descendant · 2 generations on · 1 of its ownK143184 Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015
Descendant · cites it directly · 1 of its ownK131884 Avenir Cemented Hip StemZimmer GmbH · 2013
Descendant · 2 generations on · 0 of its ownK243043 Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd. · 2025
Descendant · 3 generations on · 0 of its ownK201047 Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2013high 2 (2020) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all

K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · cites it directly5descendants
K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015 · 2 generations on1descendant
K131884Avenir Cemented Hip StemZimmer GmbH · 2013 · cites it directly1descendant
K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd. · 2025 · 2 generations on0descendants
K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993043	MS-30 Femoral Stem	Sulzer Orthopedics, Inc.	1999	—
0 (this device)	K040803	MS-30 Femoral Stem Standard and Lateral	Zimmer, Inc.	2004	—
+1	K133370	Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip…	Signature Orthopaedics Pty Limited	2014	—
+2	K143184	Evolve UniPolar Head	Signature Orthopaedics Pty, Ltd.	2015	—
+1	K131884	Avenir Cemented Hip Stem	Zimmer GmbH	2013	—
+2	K243043	Origin™ Cemented Hip Stem	Signature Orthopaedics Pty, Ltd.	2025	—
+3	K201047	Fusion Taper System	Signature Orthopaedics Pty, Ltd.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2015	1	0
2018	1	0
2020	2	0
2021	1	0
2025	1	0

FIG. 1 — Lineage of K040803, 1999–2025Source: 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? (3)

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
*	K993043	MS-30 Femoral Stem Summary page 1 …de 87 LZO) are Class 1I per 21 CFR §888.3353, reviewed by the Orthopedic Devices panel. PREDICATE DEVICES: MS-30 Femoral Stem standard: K993043, K001078 MS-30 Femoral Stem lateral: K020713 DEVICE DESCRIPTION: The MS-30 Stem is a highly polished, collarless femoral compon…	Sulzer Orthopedics, Inc.	1999	—
*	K001078	Sulzer Orthopedics MS-30 Femoral Stem Summary page 1 …) are Class 1I per 21 CFR §888.3353, reviewed by the Orthopedic Devices panel. PREDICATE DEVICES: MS-30 Femoral Stem standard: K993043, K001078 MS-30 Femoral Stem lateral: K020713 DEVICE DESCRIPTION: The MS-30 Stem is a highly polished, collarless femoral component manuf…	Sulzer Orthopedics, Inc.	2000	—
*	K020713	MS-30 Lateral Femoral Stem Summary page 1 …1I per 21 CFR §888.3353, reviewed by the Orthopedic Devices panel. PREDICATE DEVICES: MS-30 Femoral Stem standard: K993043, K001078 MS-30 Femoral Stem lateral: K020713 DEVICE DESCRIPTION: The MS-30 Stem is a highly polished, collarless femoral component manufactured from forged stainless steel…	Sulzer Orthopedics, Inc.	2002	1

Also cleared against K993043: 2 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K133370	Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…	Signature Orthopaedics Pty Limited	2014	5
K131884	Avenir Cemented Hip Stem	Zimmer GmbH	2013	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 4, 2012	Class II	Z-0217-2013	Error in labeling	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product…
Sep 4, 2012	Class II	Z-0249-2013	Error in labeling	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product…

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K133370 (Signature Orthopaedics Pty Limited, 2014) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K993043.

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.

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 MS-30 Femoral Stem is intended for cemented use in treatment of the following:

Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases.

Fractures or vascular necroses.

Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty of total hip prosthesis (THP).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040803 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040803: MS-30 Femoral Stem Standard and Lateral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040803

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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