Cleared Traditional

K253523 - Freedom DS™ Decompression System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253523 · Spinal Simplicity · Orthopedic device
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Apr 2026
Decision
154d
Days
Class 2
Risk

K253523 is an FDA 510(k) clearance for the Freedom DS™ Decompression System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Spinal Simplicity (Overland Park, US). The FDA issued a Cleared decision on April 16, 2026 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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.

View all Spinal Simplicity devices

Submission Details

510(k) Number K253523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2025
Decision Date April 16, 2026
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - HRX Arthroscope

All 679
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K253523.
VantageTM Lumbar Decompression Kit
K252546 · Allevion Medical, LLC · Mar 2026
MiiS Horus Arthroscope (EJA 100)
K253217 · Medimaging Integrated Solution, Inc (Miis) · Dec 2025
PUREVUE™ FMS
K250795 · W.O.M. World of Medicine GmbH · Dec 2025
Articulator Arthroscopic Bur
K252666 · Joint Preservation Innovations, LLC · Nov 2025
Kyphoplasty Balloon Dilatation Catheters
K252458 · Shanghai Lange Medtech Co., Ltd. · Nov 2025
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
K252020 · Hand Biomechanics Lab, Inc. · Oct 2025