Cleared Traditional

K221346 - Stryker VariAx 2 MIS Calcaneus

K221346 is the FDA 510(k) clearance for Stryker VariAx 2 MIS Calcaneus by Stryker GmbH. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K221346 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
60d
Days
Class 2
Risk

K221346 is an FDA 510(k) clearance for the Stryker VariAx 2 MIS Calcaneus. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on July 8, 2022 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 GmbH devices

Submission Details

510(k) Number K221346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2022
Decision Date July 08, 2022
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 HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K221346.
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
K210935 · I.T.S. GmbH · Aug 2022
ARIX Small Fragment System
K221920 · Jeil Medical Corporation · Aug 2022
Baby Gorilla®/Gorilla® Plating System
K222194 · Paragon 28, Inc. · Aug 2022
Footmotion Plating System
K221395 · Newclip Technics · Jul 2022
Arthrex Mini Fragment System
K220937 · Arthrex, Inc. · Jun 2022
Baby Gorilla/Gorilla Plating System
K221465 · Paragon 28, Inc. · Jun 2022