510(k) · Cleared
Recalled · Class II · 2012Alloclassic Zweymueller SL/SLL Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centerpulse Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 6, 2003 as substantially equivalent to K962101 (Intermedics Orthopedics, 1996) after a 30-day review. Its family tree reaches back 2 generations to 1987. 278 later devices descend from it. It has been recalled once.
- Decided
- Mar 6, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871453 (1987). 3 ancestors in all. 278 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK871453 Zweymueller-SL Hip Prosthesis StemAllo Pro Corp. · 1987
- 1 generation backK962101 Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
- This deviceK030373 Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003
- Descendant · cites it directly · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 2 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
Showing 5 of 278 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 278 · See all- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · cites it directly198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 2 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 2 generations on83descendants
- K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871453 | Zweymueller-SL Hip Prosthesis Stem | Allo Pro Corp. | 1987 | — |
| −1 | K962101 | Zweymueller SL Femoral Hip Stem | Intermedics Orthopedics | 1996 | — |
| 0 (this device) | K030373 | Alloclassic Zweymueller SL/SLL Femoral Stem | Centerpulse Orthopedics, Inc. | 2003 | — |
| +1 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +2 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +2 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 12 | 0 |
| 2012 | 18 | 0 |
| 2013 | 16 | 0 |
| 2014 | 15 | 0 |
| 2015 | 12 | 0 |
| 2016 | 9 | 0 |
| 2017 | 17 | 0 |
| 2018 | 15 | 0 |
| 2019 | 16 | 0 |
| 2020 | 15 | 0 |
| 2021 | 18 | 0 |
| 2022 | 15 | 0 |
| 2023 | 16 | 0 |
| 2024 | 12 | 0 |
| 2025 | 22 | 0 |
| 2026 | 20 | 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? (1)
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 2…erpulse Orthopedics believes the AlloclassicTMZweymuellerTM SL/SLL Femoral Stem is substantially equivalent to the previously cleared, ZweymuellerTMSL Femoral Stem (ref. K962101 as Exhibit 9) as it has the same indications for use, basic design, sizes, material, sterilization method and method of manufactu… | 1996 |
What descends from it? (278)
See all 2789 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042344 | Excia Total Hip System | 2005 | 198 |
| K071723 | Zimmer Porolock Mis Stem | 2008 | 73 |
| K100445 | Klassic HD Hip System | 2010 | 25 |
| K033664 | Modification to Alloclassic Zweymuller SL Offset Femoral Stem | 2003 | 8 |
| K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem | 2019 | 1 |
| K051223 | Hipstar Femoral Stem | 2006 | 1 |
| K052275 | Smith & Nephew Platform Hip Stem | 2005 | 1 |
| K170473 | C2 femoral stem | 2017 | 0 |
| K051826 | Betacone Hip Prosthesis System | 2005 | 0 |
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-0210-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042344 (Aesculap, Inc., 2005) has gone furthest, with 198 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.
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 AlloclassicTMZweymuellerTM SUSLL Femoral Stem is intended for prosthetic replacement without bone cement in treatment of the following:
. patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular
. necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. those patients with failed previous surgery where pain, deformity, or dysfunction persists.
. revision of a previously failed hip arthroplasty. patients who requires a total hip replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030373: Alloclassic Zweymueller SL/SLL 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/K030373
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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