Cleared Traditional

K223772 - PRO Plating System

K223772 is the FDA 510(k) clearance for PRO Plating System by Stryker GmbH. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K223772 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
112d
Days
Class 2
Risk

K223772 is an FDA 510(k) clearance for the PRO Plating System, Stryker Trauma Pelvic Set (Matta). 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 April 7, 2023 after a review of 112 days - within the typical 510(k) review window.

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: 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 Stryker GmbH devices

Submission Details

510(k) Number K223772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2022
Decision Date April 07, 2023
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K223772.
ARIX Humerus System
K230938 · Jeil Medical Corporation · May 2023
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
K222381 · Stryker GmbH · Apr 2023
ALPHALOK Plating System
K230204 · Vilex, LLC · Apr 2023
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
K223342 · Crossroads Extremity Systems, LLC · Mar 2023
Medartis APTUS® Ulna Plates
K223853 · Medartis AG · Mar 2023
KLS Martin Level One Rib Fixation System
K222397 · KLS-Martin L.P. · Mar 2023