Cleared Traditional

K160568 - Precision Spine Interspinous Plate System

K160568 is an FDA 510(k) clearance for Precision Spine Interspinous Plate System, manufactured by Precision Spine, Inc.. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K160568 · Precision Spine, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2016
Decision
65d
Days
Class 2
Risk

K160568 is an FDA 510(k) clearance for the Precision Spine Interspinous Plate System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Precision Spine, Inc. (Pearl, US). The FDA issued a Cleared decision on May 4, 2016 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Precision Spine, Inc. devices

FDA 510(k) Submission Details - K160568

510(k) Number K160568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date May 04, 2016
Days to Decision 65 days
Submission Type Traditional
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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEK Device Classification - Class 2, Special Controls

Product Code PEK Spinous Process Plate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition A Posterior, Non-pedicle Supplemental Fixation Device Intended For Single Level Use In The Non-cervical Spine (t1-s1). It Is Intended For Single Level Plate Fixation/attachment To Spinous Process For The Purpose Of Achieving Supplemental Fusion In The Following Conditions: Degenerative Disc Disease (defined As Back Pain Of Discogenic Origin With Degeneration Of The Disc Confirmed By History And Radiographic Studies), Trauma (i.e., Fracture Or Dislocation), Spondylolisthesis, And/or Tumor. It Is Not Intended For Stand-alone Use.
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 - PEK Spinous Process Plate

All 34
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K160568.
SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
K180156 · Globus Medical, Inc. · Mar 2018
SeaSpine Spinous Process System
K173334 · SeaSpine Orthopedics Corporation · Feb 2018
Spinal Elements' Spinous Process Plate System
K160465 · Spinal Elements, Inc. · Jul 2016
Benefix Interspinous Fixation System
K143631 · U&I Corporation · Sep 2015
Precision Spine Interspinous Plate System
K151863 · Precision Spine, Inc. · Aug 2015
Reliance Interspinous Plate System
K142217 · Reliance Medical Systems, LLC · Apr 2015