Cleared Abbreviated

K112453 - STERISPINEPS PEDICLE SCREW

K112453 is an FDA 510(k) clearance for STERISPINEPS PEDICLE SCREW, manufactured by Safe Orthopaedics. The device is a Class 2 Orthopedic device with product code NKB cleared through the Abbreviated 510(k) pathway after a 82-day FDA review.

K112453 · Safe Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
82d
Days
Class 2
Risk

K112453 is an FDA 510(k) clearance for the STERISPINEPS PEDICLE SCREW. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Safe Orthopaedics (Eragny Sur Oise, FR). The FDA issued a Cleared decision on November 15, 2011 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Safe Orthopaedics devices

FDA 510(k) Submission Details - K112453

510(k) Number K112453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2011
Decision Date November 15, 2011
Days to Decision 82 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Standards-based clearance path.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 829
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K112453.
S4 SPINAL SYSTEM
K112551 · Aesculap Implant System, Inc. · Nov 2011
CD HORIZON SPINAL SYSTEM
K113174 · Medtronic Sofamor Danek USA, Inc. · Nov 2011
SYNTHES USS
K111358 · Synthes Spine · Nov 2011
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
K112931 · Phygen, LLC · Nov 2011
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
K110655 · Mahe Medical GmbH · Oct 2011
EXPEDIUM SPINE SYSTEM
K110551 · Johnson & Johnson · Oct 2011