510(k) · Cleared
ClearedMost Hex Intramedullary (I/M) 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 Nov 14, 1997 after an 88-day review. The FDA summary names its predicate without a number. 2 of the 65 devices in its family, counting itself, have a Class I recall. 64 later devices descend from it.
- Decided
- Nov 14, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
64 later devices descend from it, 2 citing it directly. 2 of the 65 devices in this family, counting this one, have a Class I recall.
- This deviceK973087 Most Hex Intramedullary (I/M) StemSulzer Orthopedics, Inc. · 1997
- Descendant · cites it directly · 63 of its ownK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- Descendant · 2 generations on · 54 of its ownK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- Descendant · 3 generations on · 36 of its ownK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- Descendant · 3 generations on · 31 of its ownK063633 Depuy Knee Prosthesis System Universal Stem Extensions and Femoral…DePuy Orthopaedics, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 64 · See all- K003182Orthogenesis LPS SystemDepuy, Inc. · 2001 · cites it directly63descendants
- K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004 · 2 generations on54descendants
- K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006 · 3 generations on36descendants
- K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · 3 generations on31descendants
- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 4 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973087 | Most Hex Intramedullary (I/M) Stem | Sulzer Orthopedics, Inc. | 1997 | — |
| +1 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| +2 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| +3 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| +3 | K063633 | Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal… | DePuy Orthopaedics, Inc. | 2007 | 1 |
| +4 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 3 | 1 |
| 2006 | 2 | 0 |
| 2007 | 3 | 1 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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.
2 devices in this family have a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | — | Sulzer Orthopedics MOST System Named without a submission number | |
| * | — | Wright Medical Segmented Oncology System (S.O.S.) Named without a submission number | |
| * | — | Waldermar Link MP Reconstruction Prosthesis Named without a submission number | |
| * | — | Johnson & Johnson/Joint Medical Products Noiles Knee System Named without a submission number | |
| * | — | Howmedica Kinematic II Rotating Hinge Knee System Named without a submission number |
What descends from it? (64)
See all 642 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryDepuy, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K003182 (Depuy, Inc., 2001) has gone furthest, with 63 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 MOST System is intended to replace the proximal, distal and/or total femur, especially in cases that require extensive resection and restoration. The Hex I/M Stem is intended for cemented use only in these situations. Specific diagnostic indications for use of the MOST System include: metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or…
Read the full statement (134 words)
The MOST System is intended to replace the proximal, distal and/or total femur, especially in cases that require extensive resection and restoration. The Hex I/M Stem is intended for cemented use only in these situations. Specific diagnostic indications for use of the MOST System include:
metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
revision cases requiring extensive resection(s) and replacement(s) of the proximal, distal, or total femur.
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/K973087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973087: Most Hex Intramedullary (I/M) Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973087
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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