# K171369: M.U.S.T. MINI Posterior Cervical Screws System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Aug 1, 2017 after 83 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: 17 generations back to K040583 (2004). 233 ancestors in all.
8 later devices descend from it; 4 cite it directly.
1 of 242 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K070573: Synapse System, Synthes Spine Co.Lp (2007) Summary page 4.
- K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 4.
- K991089: Synthes Cervifix System, Synthes Spine (1999) Summary page 4.
- K123906: Vertex Reconstruction System, Vertext Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.
- K110197: Exactech Gibralt Spinal System, Exactech, Inc. (2011) Summary page 4.
- K030197: Blackstone Posterior Cervical System, Blackstone Medical, Inc. (2003) Summary page 4.
- K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System, Pioneer Surgical Technology, Inc. (2012) Summary page 5.
- K132878: M.U.S.T. Extension, Medacta International (2013) Summary page 5.
- K141988: M.U.S.T Pedicle Screw System, Medacta International (2014) Summary page 5.
- K153664: M.U.S.T. Pedicle Screw System, Medacta International (2016) Summary page 5.
- K162061: M.U.S.T. Pedicle Screw System, Medacta International S.A. (2016) Summary page 5.
- K171170: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws, Medacta International S.A. (2017). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K200130: M.U.S.T. MINI Posterior Cervical Screws System (2020), 6 descendants of its own
- 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
- K182837: M.U.S.T. Mini Extension (2019), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
The M.U.S.T. Mini posterior cervical screwV system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion 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 screwV 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 screwV 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 screwV 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.

Source page: https://510kreport.com/device/K171369
Methodology: https://510kreport.com/methodology