# K182837: M.U.S.T. Mini Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 22, 2019 after 105 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). 244 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 246 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011) Summary page 4.
- K171369: M.U.S.T. MINI Posterior Cervical Screws System, Medacta International S.A. (2017) Summary page 4.
- K070573: Synapse System, Synthes Spine Co.Lp (2007) Summary page 4.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 4.
- K111076: Solanas Avalon Posterior Fixation System, Alphatec Spine, Inc. (2011) Summary page 4.

## Most influential descendants
- K203149: M.U.S.T. MINI Posterior Cervical Screws 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/K182837
Methodology: https://510kreport.com/methodology