510(k) · Cleared
ClearedMUTARS® femoral stem cemented 160 mm and 200 mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Oct 24, 2024 as substantially equivalent to K200045 (Implantcast GmbH, 2020) and 1 other predicate after a 259-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Oct 24, 2024
- Review
- 259 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K965164 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK965164 Howmedica Modular Replacement System-Proximal FemurHowmedica Corp. · 1997
- 2 generations backK181778 MUTARS Proximal Femur Replacement SystemImplantcast GmbH · 2019
- 1 generation backK200045 MUTARS Cemented Femoral StemsImplantcast GmbH · 2020
- This deviceK240391 MUTARS® femoral stem cemented 160 mm and 200 mmImplantcast GmbH · 2024
- Descendant · cites it directly · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Most influential descendants
Showing 1 of 1 · See all- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K965164 | Howmedica Modular Replacement System-Proximal Femur | Howmedica Corp. | 1997 | — |
| −2 | K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | 2019 | — |
| −1 | K200045 | MUTARS Cemented Femoral Stems | Implantcast GmbH | 2020 | — |
| 0 (this device) | K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | Implantcast GmbH | 2024 | — |
| +1 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K200045 | MUTARS Cemented Femoral StemsSummary page 7…the existing stems. The new stems are available with longer lengths (160 and 200mm). Primary Predicate MUTARS® Cemented Femoral Stems (K200045) Device: Additional Predicate MUTARS® Proximal Femur Replacement System Device: (K181778) Substantial… | 2020 |
| * | K181778 | MUTARS Proximal Femur Replacement SystemSummary page 7…00mm). Primary Predicate MUTARS® Cemented Femoral Stems (K200045) Device: Additional Predicate MUTARS® Proximal Femur Replacement System Device: (K181778) Substantial The MUTARS® femoral stem cemented 160 mm and 200 Equivalence: mm is substantially equivalent… | 2019 |
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 |
|---|---|---|---|
| K260037 | implantcast Packaging System Update | 2026 | 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 27 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K260037 (Implantcast GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200045.
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. 2024, 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?
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur System is intended for cemented and uncemented use in total hip arthroplasty or hemiarthroplasty for the following indications: * Proximal femur…
Read the full statement (120 words)
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.
The MUTARS® Proximal Femur System is intended for cemented and uncemented use in total hip arthroplasty or hemiarthroplasty for the following indications:
* Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
» Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Use of this prosthesis is generally only indicated in skeletally mature patients.
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/K240391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240391: MUTARS® femoral stem cemented 160 mm and 200 mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240391
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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