510(k) · Cleared
ClearedMUTARS Proximal Femur Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Mar 25, 2019 as substantially equivalent to K965164 (Howmedica Corp., 1997) and 1 other predicate after a 265-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Mar 25, 2019
- Review
- 265 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K965164 (1997). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK965164 Howmedica Modular Replacement System-Proximal FemurHowmedica Corp. · 1997
- This deviceK181778 MUTARS Proximal Femur Replacement SystemImplantcast GmbH · 2019
- Descendant · cites it directly · 2 of its ownK200045 MUTARS Cemented Femoral StemsImplantcast GmbH · 2020
- Descendant · cites it directly · 1 of its ownK240391 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965164 | Howmedica Modular Replacement System-Proximal Femur | Howmedica Corp. | 1997 | — |
| 0 (this device) | K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | 2019 | — |
| +1 | K200045 | MUTARS Cemented Femoral Stems | Implantcast GmbH | 2020 | — |
| +1 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 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.
Planning a device in MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | K965164 | Howmedica Modular Replacement System-Proximal FemurSummary page 4…52.5798 [email protected] March 21, 2019 Proximal Femur Replacement 21 CFR §888.3353 21 CFR §888.3390 II MEH, LZO0, Stryker GMRS Proximal Femoral Replacement System (K965164, K023087) Ecofit Hip System (K163577) K181778 Page 2 of 2 Indications for Use: The MUTARS® Proximal Femur Repl… | 1997 |
| * | K023087 | Global Modular Replacement System (GMRS)Summary page 4…[email protected] March 21, 2019 Proximal Femur Replacement 21 CFR §888.3353 21 CFR §888.3390 II MEH, LZO0, Stryker GMRS Proximal Femoral Replacement System (K965164, K023087) Ecofit Hip System (K163577) K181778 Page 2 of 2 Indications for Use: The MUTARS® Proximal Femur Replacement S… | 2002 |
| † | K163577 | Ecofit® Hip System | 2017 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
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 to for uncemented use in total hip arthroplasty for the following indications: - Proximal femur replacement in oncology cases where…
Read the full statement (117 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 to for uncemented use in total hip arthroplasty 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/K181778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181778: MUTARS Proximal Femur Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181778
Report an extraction error
Are you the manufacturer?
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