510(k) · Cleared
ClearedAlloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 26, 2019 as substantially equivalent to K962101 (Intermedics Orthopedics, 1996) and 2 other predicates after a 55-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Dec 26, 2019
- Review
- 55 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K871453 (1987). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK871453 Zweymueller-SL Hip Prosthesis StemAllo Pro Corp. · 1987
- 3 generations backK962101 Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
- 2 generations backK030373 Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
- 1 generation backK033664 Modification to Alloclassic Zweymuller SL Offset Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
- This deviceK193050 Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL…Zimmer GmbH · 2019
- Descendant · cites it directly · 0 of its ownK200112 Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K200112Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871453 | Zweymueller-SL Hip Prosthesis Stem | Allo Pro Corp. | 1987 | — |
| −3 | K962101 | Zweymueller SL Femoral Hip Stem | Intermedics Orthopedics | 1996 | — |
| −2 | K030373 | Alloclassic Zweymueller SL/SLL Femoral Stem | Centerpulse Orthopedics, Inc. | 2003 | 1 |
| −1 | K033664 | Modification to Alloclassic Zweymuller SL Offset Femoral Stem | Centerpulse Orthopedics, Inc. | 2003 | 1 |
| 0 (this device) | K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset… | Zimmer GmbH | 2019 | — |
| +1 | K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K962101 | Zweymueller SL Femoral Hip StemSummary page 4…emented prosthesis. Predicate Device: Alloclassic® Zweymüller® SL Femoral Stem, manufactured by Zimmer GmbH, K962101, first cleared August 19, 1996, subsequently modified by a design change and cleared March… | 1996 |
| * | K030373 | Alloclassic Zweymueller SL/SLL Femoral StemSummary page 4…d August 19, 1996, subsequently modified by a design change and cleared March 6, 2003 under K030373 Alloclassic® Zweymüller® SL Offset Femoral Stem, manufactured… | 2003 |
| * | K033664 | Modification to Alloclassic Zweymuller SL Offset Femoral StemSummary page 4…under K030373 Alloclassic® Zweymüller® SL Offset Femoral Stem, manufactured by Zimmer GmbH, K033664, cleared December 17, 2003 Device Description: The Alloclassic® Zweymüller® SL Femoral Stem is designed as a… | 2003 |
| † | K182048 | Avenir Complete Hip System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200112 | Zimmer Hip Joint Replacement | 2020 | 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 32 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K200112 (Zimmer GmbH, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K962101.
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. 2019, this device’s year, is highlighted.
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?
Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:
• Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• Failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193050: Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset 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/K193050
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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