Cleared Traditional

K201362 - CD Horizon Fenestrated Screw Set

K201362 is the FDA 510(k) clearance for CD Horizon Fenestrated Screw Set by Medtronic. It is a Class 2 Orthopedic device (product code PML) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K201362 · Medtronic · Orthopedic device
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Aug 2020
Decision
89d
Days
Class 2
Risk

K201362 is an FDA 510(k) clearance for the CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ B.... Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on August 19, 2020 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Medtronic devices

Submission Details

510(k) Number K201362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2020
Decision Date August 19, 2020
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PML Bone Cement, Posterior Screw Augmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
Definition The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.
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 - PML Bone Cement, Posterior Screw Augmentation

All 16
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K201362.
BonOs® Inject Bone Cement
K222256 · Neo Medical SA · Aug 2022
BonOs Inject Bone Cement
K212489 · Neo Medical SA · Oct 2021
G21 Cement, VADER® Pedicle System
K200596 · Icotec AG · Oct 2020
Vertaplex HV High Viscosity Radiopaque Bone Cement
K192818 · Stryker Corporation · Mar 2020
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
K190526 · CarboFix Orthopedics , Ltd. · Sep 2019
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
K191148 · Medtronic Sofamor Danek USA, Inc. · Sep 2019