510(k) · Cleared
Recalled · Class II · 2012MS-30 Lateral Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 14, 2002 after a 70-day review. The FDA summary names its predicate without a number. 19 later devices descend from it. It has been recalled once.
- Decided
- May 14, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK020713 MS-30 Lateral Femoral StemSulzer Orthopedics, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK083558 Medacta Total Hip Prosthesis System - Quadra CMedacta International S.A. · 2009 · Recalled
- Descendant · cites it directly · 8 of its ownK040803 MS-30 Femoral Stem Standard and LateralZimmer, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 6 of its ownK192827 Quadra-PMedacta International S.A. · 2020
- Descendant · 2 generations on · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
- Descendant · 3 generations on · 1 of its ownK202730 Quadra-PMedacta International S.A. · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K083558Medacta Total Hip Prosthesis System - Quadra CMedacta International S.A. · 2009 · cites it directly9descendants
- K040803MS-30 Femoral Stem Standard and LateralZimmer, Inc. · 2004 · cites it directly8descendants
- K192827Quadra-PMedacta International S.A. · 2020 · 2 generations on6descendants
- K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · 2 generations on5descendants
- K202730Quadra-PMedacta International S.A. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020713 | MS-30 Lateral Femoral Stem | Sulzer Orthopedics, Inc. | 2002 | — |
| +1 | K083558 | Medacta Total Hip Prosthesis System - Quadra C | Medacta International S.A. | 2009 | 1 |
| +1 | K040803 | MS-30 Femoral Stem Standard and Lateral | Zimmer, Inc. | 2004 | 2 |
| +2 | K192827 | Quadra-P | Medacta International S.A. | 2020 | — |
| +2 | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… | Signature Orthopaedics Pty Limited | 2014 | — |
| +3 | K202730 | Quadra-P | Medacta International S.A. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | — | MS-30 Femoral Stem, Centralizer Named without a submission number | |
| * | — | Howmedica Osteonics Exeter Hip Stem, Centralizer Named without a submission number | |
| * | — | Howmedica Osteonics Definitive Stem Named without a submission number | |
| * | — | Zimmer VerSys Hip Cemented CT Hip Stem, Centralizer Named without a submission number |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0219-2013 | 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?
- Of its descendants, K083558 (Medacta International S.A., 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All LZO devicesLZO 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 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 Lateral Femoral Stem is intended for cemented use in treatment of the following:
1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
3. Revision of previously failed hip arthroplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020713: MS-30 Lateral 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/K020713
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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