# K200130: M.U.S.T. MINI Posterior Cervical Screws System

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Feb 10, 2020 after 20 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K040583 (2004). 234 ancestors in all.
6 later devices descend from it; 4 cite it directly.
1 of 241 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171369: M.U.S.T. MINI Posterior Cervical Screws System, Medacta International S.A. (2017) Summary page 4.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K070573: Synapse System, Synthes Spine Co.Lp (2007)
- K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 4.
- K991089: Synthes Cervifix System, Synthes Spine (1999) Summary page 4.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 4.

## Most influential descendants
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own
- K220570: M.U.S.T. MINI Posterior Cervical Screws System Extension (2022), 0 descendants of its own
- K203125: Invictus™ OCT Spinal Fixation System (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K200130
Methodology: https://510kreport.com/methodology