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510(k) K142146

IBIS PEDICLE SCREW SYSTEM by Ortho Development Corp. — Product Code NKB

K142146 is an FDA 510(k) premarket notification submitted by Ortho Development Corp. for the device "IBIS PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on December 11, 2014. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Ortho Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2014
Date Received
August 5, 2014
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 Ortho Development Corp.

  • K253161 — Balanced Knee System TriMax Porous Femoral Components (December 19, 2025)
  • K251052 — Trivicta® Hip Stem (May 22, 2025)
  • K242984 — BKS Revision System (October 25, 2024)
  • K242833 — Legend® Acetabular Shell (October 11, 2024)
  • K233758 — Trivicta™ Hip Stem (March 8, 2024)
  • K141001 — ALPINE HIP STEM; ALPINE HA HIP STEM (July 30, 2014)
  • K132697 — ENCOMPASS 10/12 HIP STEM (June 20, 2014)
  • K133386 — OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM (March 11, 2014)
  • K133449 — KASM KNEE ARTICULATING SPACER MOLDS (February 18, 2014)
  • K131022 — OVATION 10/12 HIP STEM (October 16, 2013)

Other clearances for product code NKB

  • 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)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources