Cleared Traditional

K073228 - DC ULNAR SHORTENING SYSTEM

K073228 is an FDA 510(k) clearance for DC ULNAR SHORTENING SYSTEM, manufactured by Orthopro, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K073228 · Orthopro, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
106d
Days
Class 2
Risk

K073228 is an FDA 510(k) clearance for the DC ULNAR SHORTENING SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthopro, LLC (Round Rock, US). The FDA issued a Cleared decision on February 29, 2008 after a review of 106 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 Orthopro, LLC devices

FDA 510(k) Submission Details - K073228

510(k) Number K073228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2007
Decision Date February 29, 2008
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1052
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K073228.
AAP BONE PLATES AND SCREW IMPLANTS
K072411 · Aap Implantate AG · Mar 2008
MODULAR FOOT SYSTEM
K073624 · Orthohelix Surgical Designs, Inc. · Mar 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667 · Howmedica Osteonics Corp. · Mar 2008
CHARLOTTE CLAW 3.5
K080295 · Wrightmedicaltechnologyinc · Feb 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K073460 · Synthes (Usa) · Feb 2008
BIOFOAM BONE WEDGE
K073535 · Wrightmedicaltechnologyinc · Jan 2008