Cleared Traditional

K153302 - coflex-IF

K153302 is an FDA 510(k) clearance for coflex-IF, manufactured by Paradigm Spine, LLC. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K153302 · Paradigm Spine, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
300d
Days
Class 2
Risk

K153302 is an FDA 510(k) clearance for the coflex-IF. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Paradigm Spine, LLC (New York, US). The FDA issued a Cleared decision on September 8, 2016 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K153302

510(k) Number K153302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2015
Decision Date September 08, 2016
Days to Decision 300 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
178d slower than avg
Panel avg: 122d · This submission: 300d
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 Consultant

Musculoskeletal Clinical Regulatory Advisers, LLC
Justin Eggleton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PEK Spinous Process Plate

All 48
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K153302.
Huvex Interspinous Fixation System
K162849 · Dio Medical Co., Ltd. · Feb 2017
HA Minuteman G3-R MIS Fusion Plate
K163428 · Spinal Simplicity · Feb 2017
Z-Clamp ISP System
K161016 · Zavation, LLC · Oct 2016
Spinal Elements' Spinous Process Plate System
K160465 · Spinal Elements, Inc. · Jul 2016
Precision Spine Interspinous Plate System
K160568 · Precision Spine, Inc. · May 2016
Benefix Interspinous Fixation System
K143631 · U&I Corporation · Sep 2015