Streamline OCT Occipito-Cervico-Thoracic System— 510(k) K150254

Clearance details

Applicant

Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Product code

Code KWP

Device class

Class 2

Regulation

21 CFR 888.3050

Advisory panel

Orthopedic

Date received

2015-02-03

Decision date

2015-04-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marquette, MI, 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
• K142253 — SOLSTICE OCT System2015-04-23

• K201497 — EVOS Cabling System2020-10-28
• K200095 — Streamline Navigated Instruments2020-06-26
• K193468 — Tritium Sternal Cable Plate System2020-03-12
• K192800 — Streamline TL Spinal Fixation System2020-01-14
• K192718 — Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology2019-12-20

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-0290-2017 — RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.Class II·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·20160916
• Z-1829-2016 — Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.Class II·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·20160422
• Z-1393-2016 — RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw DriverClass II·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·20160318

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150254.