M.U.S.T PEDICLE SCREW SYSTEM— 510(k) K121115

Clearance details

Applicant

Medacta International

Product code

Code KWP

Device class

Class 2

Regulation

21 CFR 888.3050

Advisory panel

Orthopedic

Date received

2012-04-12

Decision date

2012-07-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Camarillo, CA, US

• K143278 — LnK Posterior Cervical Fixation System2015-07-29
• K150753 — OASYS System2015-06-09
• K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
• K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
• K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

• K160605 — MectaLIF Anterior Stand-Alone2016-07-21
• K160289 — MasterLoc Stem2016-05-20
• K153664 — M.U.S.T. Pedicle Screw System2016-01-19
• K151531 — MasterLoc Stem2015-10-30
• K142744 — Mecta-C TiPEEK2015-05-07

Death

7

Injury

1,539

Malfunction

1,519

Total

3,065

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1023-2017 — Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.Class II·Terminated·Medacta Usa Inc·20161207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121115.