510(k) · Cleared
ClearedZweymueller SL Femoral Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 19, 1996 as substantially equivalent to K871453 (Allo Pro Corp., 1987) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1987. 283 later devices descend from it.
- Decided
- Aug 19, 1996
- Review
- 81 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871453 (1987). 2 ancestors in all. 283 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK871453 Zweymueller-SL Hip Prosthesis StemAllo Pro Corp. · 1987
- This deviceK962101 Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
- Descendant · cites it directly · 278 of its ownK030373 Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 3 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
Showing 5 of 283 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 283 · See all- K030373Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · cites it directly278descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 3 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 3 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871453 | Zweymueller-SL Hip Prosthesis Stem | Allo Pro Corp. | 1987 | — |
| 0 (this device) | K962101 | Zweymueller SL Femoral Hip Stem | Intermedics Orthopedics | 1996 | — |
| +1 | K030373 | Alloclassic Zweymueller SL/SLL Femoral Stem | Centerpulse Orthopedics, Inc. | 2003 | 1 |
| +2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +3 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +3 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +3 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
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 | 2 | 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 | 16 | 0 |
| 2015 | 12 | 0 |
| 2016 | 9 | 0 |
| 2017 | 17 | 0 |
| 2018 | 15 | 0 |
| 2019 | 16 | 0 |
| 2020 | 17 | 0 |
| 2021 | 18 | 0 |
| 2022 | 15 | 0 |
| 2023 | 16 | 0 |
| 2024 | 12 | 0 |
| 2025 | 23 | 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? (2)
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 |
|---|---|---|---|
| * | K871453 | Zweymueller-SL Hip Prosthesis StemSummary page 2…a line extension of an existing legally marketed SOL's Zweymueller-SL Hip Prosthesis which has previously been determined substantially equivalent by the FDA via 510(k) #K871453. The Zweymueller SL. Femoral Hip Stem is identical in design to the predicate Zweymueller-SL Hip Prosthesis except for the follo… | 1987 |
| * | K930963 | SL-Plus & SLR-Plus Stems W/Biolox Ceramic HeadsSummary page 3…] STy o) [Zweymueller-SL| SL-Plus Hip Stem Hip Prosthesis Manufacturer Sulzer Sulzer Plus Orthopedics Orthopedics | Endoprothetik. Limited Limited 510(k) No. - K871453 K930963 Application Cementless Cementless Cementless Material Titanium Alloy| Titanium Alloy | Unknown to 101 Rectangular Yes Yes Yes cro… | 1994 |
What descends from it? (283)
See all 2834 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030373 | Alloclassic Zweymueller SL/SLL Femoral Stem | 2003 | 278 |
| K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem… | 2014 | 5 |
| K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem | 2019 | 1 |
| K170473 | C2 femoral stem | 2017 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K030373 (Centerpulse Orthopedics, Inc., 2003) has gone furthest, with 278 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 Zweymueller SL Femoral Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the Zweymueller SL Femoral Hip Stem is intended to be intraoperatively assembled to the commercially available Sulzer Orthopedics Limited (SOL) or Intermedics Orthopedics, Inc. (IOI) femoral bearing heads.
The general indications associated with the use of Zweymueller SL
2. Fracture or avascular necrosis.
3. Conditions consequent to earlier operations such as joint reconstruction (Osteotomy), arthrodesis, hemi-arthroplasty, or total hip replacement (THP), total knee replacement, as well as “operations on shoulder and elbow joints, and spinal surgery.
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/K962101 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962101: Zweymueller SL Femoral Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962101
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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