FORTEX PEDICLE SCREW SYSTEM— 510(k) K120832

Clearance details

Applicant

X-Spine Systems, Inc.

Product code

Code MNH

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2012-03-19

Decision date

2012-10-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Miamisburg, OH, US

• K162066 — Reliance Spinal Screw System2016-12-02
• K162801 — CastleLoc Spinal Fixation System2016-11-03
• K162143 — FixxSure® X-Link2016-09-23
• K161151 — Spinal fixation system2016-09-21
• K162189 — ANAX 5.5 Spinal System2016-08-30

• K173832 — InTice-C Porous Ti Cervical Interbody System2018-05-17
• K180153 — X-spine Cortical Bone Screw System2018-03-15
• K170119 — Calix Lumbar Spinal Implant System2017-09-29
• K171567 — IRIX-A Lumbar Integrated Fusion System2017-08-28
• K171075 — Calix-C Cervical Interbody Spacer2017-08-01

Injury

978

Malfunction

793

Total

1,771

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-1884-2017 — 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).Class II·Terminated·XTANT MEDICAL INC·20170412
• Z-1823-2015 — Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400Class II·Terminated·X Spine Systems Inc·20150407
• Z-1512-2015 — Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.Class II·Terminated·X Spine Systems Inc·20150311

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120832.