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510(k) K192396

Streamline MIS Spinal Fixation System by Pioneer Surgical Technology, Inc. — Product Code NKB

K192396 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. for the device "Streamline MIS Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on November 26, 2019. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Pioneer Surgical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2019
Date Received
September 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Pioneer Surgical Technology, Inc.

  • K261271 — Cable-Ready® Cable Grip System (July 16, 2026)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K222493 — CODA™ Anterior Cervical Plate System (November 18, 2022)
  • K211408 — CervAlign® Anterior Cervical Plate System (June 23, 2021)
  • K140696 — STREAMLINE TL SPINAL FIXATION SYSTEM (April 10, 2014)
  • K133455 — CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC (March 27, 2014)
  • K133623 — C-PLUS (February 10, 2014)
  • K132050 — NB3D BONE VOID FILLER (February 7, 2014)
  • K133785 — TRITIUM STERNAL CABLE PLATE SYSTEM (January 27, 2014)
  • K131724 — PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE (December 24, 2013)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources