510(k) · Cleared
ClearedM.U.S.T. MINI Posterior Cervical Screws System Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · NKG Posterior Cervical Screw System
Cleared on Apr 26, 2022 as substantially equivalent to K171369 (Medacta International S.A., 2017) and 2 other predicates after a 57-day review. Its family tree reaches back 19 generations to 2004. 1 of the 248 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 26, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K040583 (2004). 247 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 248 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 backK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
- 1 generation backK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
- This deviceK220570 M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A. · 2022
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 backK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
- 1 generation backK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
- This deviceK220570 M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A. · 2022
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
View 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 | K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2017 | — |
| −1 | K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020 | — |
| 0 (this device) | K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | Medacta International S.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 9 | 0 |
| 2000 | 15 | 0 |
| 2001 | 16 | 0 |
| 2002 | 14 | 0 |
| 2003 | 19 | 0 |
| 2004 | 34 | 0 |
| 2005 | 21 | 0 |
| 2006 | 14 | 0 |
| 2007 | 11 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 1 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 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.
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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K171369 | M.U.S.T. MINI Posterior Cervical Screws SystemSummary page 4…Predicate Device Substantial equivalence is claimed to the following predicate devices: Primary predicate device: M.U.S.T. MINI Posterior Cervical Screws System, K171369, Medacta International SA Additional predicate devices: M.U.S.T. MINI Posterior Cervical Screws System Extension, K200130,… | 2017 |
| * | K200130 | M.U.S.T. MINI Posterior Cervical Screws SystemSummary page 4…T. MINI Posterior Cervical Screws System, K171369, Medacta International SA Additional predicate devices: M.U.S.T. MINI Posterior Cervical Screws System Extension, K200130, Medacta International SA BRIDALVEIL Occipital Cervical Thoracic System, K171250, Astura Medical Reference devices:… | 2020 |
| * | K171250 | BRIDALVEIL Occipital Cervical Thoracic SystemSummary page 4…cate devices: M.U.S.T. MINI Posterior Cervical Screws System Extension, K200130, Medacta International SA BRIDALVEIL Occipital Cervical Thoracic System, K171250, Astura Medical Reference devices: M.U.S.T. Pedicle Screw System, Medacta International, K121115, Medacta International SA… | 2017 |
| † | K121115 | M.U.S.T Pedicle Screw System | 2012 |
| † | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 32 of the 247 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K171369.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The M.U.S.T. Mini posterior cervical screw system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures, and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the…
Read the full statement (249 words)
The M.U.S.T. Mini posterior cervical screw system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures, and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The M.U.S.T. Mini posterior cervical screw system is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the M.U.S.T. Mini posterior cervical screw system may be connected to the M.U.S.T. system rods with the M.U.S.T. Mini rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. Mini posterior cervical screw system to the M.U.S.T. system. Refer to the M.U.S.T. system package insert for a list of the M.U.S.T. indications of use.
When used with the occipital plate the M.U.S.T. Mini posterior cervical screw system is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction (occiput - T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
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/K220570 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220570: M.U.S.T. MINI Posterior Cervical Screws System Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220570
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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