M.U.S.T. Pedicle Screw System
by Medacta International S.A. 2 variants
510(k) K193365
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193365 | Date27 Jan 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The M.U.S.T. Pedicle Screw System is a spinal fixation device designed for posterior non-cervical pedicle fixation (T1–S2/ilium) and anterolateral fixation (T8–L5). It employs threaded screws and modular connectors to stabilize vertebrae, supporting surgical interventions such as spinal fusion and alignment correction. The system leverages Medacta’s Unconstrained Screw Technology to accommodate diverse anatomical variations, ensuring adaptability in orthopedic procedures.
This system is supplied as a sterile, single-use orthopedic implant set, including screws, rods, and specialized instruments. It is cleared for use under FDA 510(k) (K193365) and is intended for sterile surgical environments. The screws are engineered for adult spinal fixation, with configurations tailored to pedicle and lateral fixation requirements. No MRI safety information is provided in the available data.