Cleared Traditional

K202393 - SpineJack Expansion Kit

K202393 is the FDA 510(k) clearance for SpineJack Expansion Kit by Stryker Corporation. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K202393 · Stryker Corporation · Orthopedic device
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Oct 2020
Decision
60d
Days
Class 2
Risk

K202393 is an FDA 510(k) clearance for the SpineJack Expansion Kit. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on October 20, 2020 after a review of 60 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 Stryker Corporation devices

Submission Details

510(k) Number K202393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2020
Decision Date October 20, 2020
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 44
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K202393.
KYPHON VuE Bone Cement
K220131 · Tecres S.P.A. · Apr 2022
TRACKER Plus Kyphoplasty System
K211797 · GS Medical Co., Ltd. · Oct 2021
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
K211238 · Stryker Instruments · Jun 2021
CONFIDENCE Spinal Cement System
K201831 · Depuy Spine, Inc. · Aug 2020
Joline Kyphoplasty System Allevo
K192449 · Joline GmbH & Co. KG · May 2020
V-STRUT Vertebral Implant
K191709 · Hyprevention Sas · Mar 2020