510(k) · Cleared
ClearedMeta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · PML Bone Cement, Posterior Screw Augmentation
Cleared on Jun 12, 2024 as substantially equivalent to K160879 (Medos International Sàrl, 2016) and 6 other predicates after a 57-day review. Its family tree reaches back 19 generations to 2004. 1 of the 173 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 12, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 19 generations to K040583 (2004). 170 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly. 1 of the 173 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations between
- 3 generations backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- 2 generations backK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
- 1 generation backK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
- This deviceK241034 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024
- Descendant · cites it directly · 0 of its ownK260286 Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252885 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2026
Show all 19 generations
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 7 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 6 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
- 5 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
- 4 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
- 3 generations backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- 2 generations backK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
- 1 generation backK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
- This deviceK241034 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −16 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −14 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −11 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −10 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −9 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −8 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −7 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −6 | K132878 | M.U.S.T. Extension | Medacta International | 2013 | — |
| −5 | K141988 | M.U.S.T Pedicle Screw System | Medacta International | 2014 | — |
| −4 | K153664 | M.U.S.T. Pedicle Screw System | Medacta International | 2016 | — |
| −3 | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional… | Medacta International S.A. | 2017 | — |
| −2 | K193365 | M.U.S.T. Pedicle Screw System | Medacta International S.A. | 2020 | — |
| −1 | K203482 | M.U.S.T. Pedicle Screw Extension and Long Tab Implants | Medacta International S.A. | 2021 | — |
| 0 (this device) | K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. | 2024 | — |
| +1 | K260286 | Dynamo™ Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | 2026 | — |
| +1 | K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 14 | 0 |
| 2001 | 12 | 0 |
| 2002 | 7 | 0 |
| 2003 | 13 | 0 |
| 2004 | 20 | 0 |
| 2005 | 14 | 0 |
| 2006 | 10 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 1 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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.
1 device in this family has 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 PML device
- #1 K200596 G21 Cement, VADER® Pedicle Systemscore 24.9 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsSummary page 4…the following predicate devices. Primary Predicate device: • CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems, K160879, DePuy Spine, Inc. Additional Predicate devices • M.U.S.T. Pedicle Screw Extension, K203482, Medacta International SA… | 2016 |
| * | K203482 | M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsSummary page 4…al Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems, K160879, DePuy Spine, Inc. Additional Predicate devices • M.U.S.T. Pedicle Screw Extension, K203482, Medacta International SA • M.U.S.T. Pedicle Screw System, K171170, Medacta International SA • M.U.S.T. Pedicle Screw S… | 2021 |
| * | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsSummary page 4…79, DePuy Spine, Inc. Additional Predicate devices • M.U.S.T. Pedicle Screw Extension, K203482, Medacta International SA • M.U.S.T. Pedicle Screw System, K171170, Medacta International SA • M.U.S.T. Pedicle Screw System, K141988, Medacta International SA • M.U.S.T. Pedicle Screw S… | 2017 |
| * | K141988 | M.U.S.T Pedicle Screw SystemSummary page 4…Pedicle Screw Extension, K203482, Medacta International SA • M.U.S.T. Pedicle Screw System, K171170, Medacta International SA • M.U.S.T. Pedicle Screw System, K141988, Medacta International SA • M.U.S.T. Pedicle Screw System, K132878, Medacta International SA • M.U.S.T. Pedicle Screw S… | 2014 |
| * | K132878 | M.U.S.T. ExtensionSummary page 4….T. Pedicle Screw System, K171170, Medacta International SA • M.U.S.T. Pedicle Screw System, K141988, Medacta International SA • M.U.S.T. Pedicle Screw System, K132878, Medacta International SA • M.U.S.T. Pedicle Screw System, K121115, Medacta International SA • F20, K103433, Teknimed S… | 2013 |
| * | K121115 | M.U.S.T Pedicle Screw SystemSummary page 4….T. Pedicle Screw System, K141988, Medacta International SA • M.U.S.T. Pedicle Screw System, K132878, Medacta International SA • M.U.S.T. Pedicle Screw System, K121115, Medacta International SA • F20, K103433, Teknimed SAS IV. Device Description The purpose of this submission is to gain… | 2012 |
| * | K103433 | F20Summary page 4…ernational SA • M.U.S.T. Pedicle Screw System, K132878, Medacta International SA • M.U.S.T. Pedicle Screw System, K121115, Medacta International SA • F20, K103433, Teknimed SAS IV. Device Description The purpose of this submission is to gain the clearance for the Meta+ Spine Cement to be… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 28 of the 170 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K260286 (Spine Wave, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K160879.
How does its category compare?
All PML devicesPML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PML
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PML
116in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PML
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PML
55in 2025
MAUDE reports naming product code PML, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 35 |
| 2020 | 3 | 182 | 0 | 27 |
| 2021 | 1 | — | 0 | 32 |
| 2022 | 2 | — | 0 | 12 |
| 2023 | 3 | 116 | 2 | 18 |
| 2024 | 1 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The M.U.S.T. Fenestrated Pedicle Screw System when used without cement is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or…
Read the full statement (260 words)
The M.U.S.T. Fenestrated Pedicle Screw System when used without cement is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in conjunction with Meta+ Spine cement, the M.U.S.T. Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. M.U.S.T. Fenestrated Pedicle Screw System augmented with Meta+ Spine cement is intended for use at spinal levels where the structural integrity of the spine is not severely compromised.
Meta+ Spine cement, when used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. The M.U.S.T. Fenestrated Pedicle Screw System, augmented with Meta+ Spine Cement, is for use at spinal levels where the structural integrity of the spine is not severely compromised.
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/K241034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241034: Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241034
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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