STREAMLINE MIS SPINAL FIXATION SYSTEM— 510(k) K130286

Clearance details

Applicant

Pioneer Surgical Technology, Inc.

Product code

Product code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2013-02-05

Decision date

2013-04-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marquette, MI, US

• K261217 — AnyPlus II Spinal Fixation System2026-10-02
• K263062 — NOVIX Pedicle Screw System2026-10-01
• K262712 — Duet Spinal Fixation System2026-09-30
• K263172 — SAS MIS Pelvic Incidence Rods2026-09-30
• K252139 — Kentrospine Viktr-MIS® Pedicle screw system2026-09-27

• K261271 — Cable-Ready® Cable Grip System2026-07-16
• K251436 — Resolve Anterior Cervical Plate System2025-07-11
• K222493 — CODA Anterior Cervical Plate System2022-11-18
• K211408 — CervAlign® Anterior Cervical Plate System2021-06-23
• K192396 — Streamline MIS Spinal Fixation System2019-11-26

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

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-2616-2014 — Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.Class II·Terminated·PIONEER SURGICAL TECHNOLOGY, INC.·20130614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130286.