Cleared Traditional

K182352 - SP-LINK System

K182352 is the FDA 510(k) clearance for SP-LINK System by Medical Designs, LLC. It is a Class 2 Orthopedic device (product code PEK) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K182352 · Medical Designs, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
84d
Days
Class 2
Risk

K182352 is an FDA 510(k) clearance for the SP-LINK™ System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Medical Designs, LLC (Sioux Falls, US). The FDA issued a Cleared decision on November 21, 2018 after a review of 84 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 Medical Designs, LLC devices

Submission Details

510(k) Number K182352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2018
Decision Date November 21, 2018
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K182352.
Inspan ScrewLES Fusion System
K213266 · Lespine Innovations, LLC · Dec 2021
Posterior Fusion Plate, HA Posterior Fusion Plate
K200066 · Spinal Simplicity, LLC · Dec 2020
CoFix System
K201704 · Paradigm Spine GmbH · Aug 2020
AERIAL™ Interspinous Fixation
K180817 · Globus Medical, Inc. · May 2018
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