Cleared Traditional

K023007 - DISTAL RADIUS FRACTURE REPAIR SYSTEM

K023007 is an FDA 510(k) clearance for DISTAL RADIUS FRACTURE REPAIR SYSTEM, manufactured by Hand Innovations, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K023007 · Hand Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
87d
Days
Class 2
Risk

K023007 is an FDA 510(k) clearance for the DISTAL RADIUS FRACTURE REPAIR 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 Hand Innovations, Inc. (Weston, US). The FDA issued a Cleared decision on December 5, 2002 after a review of 87 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 Hand Innovations, Inc. devices

FDA 510(k) Submission Details - K023007

510(k) Number K023007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date December 05, 2002
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 1105
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K023007.
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
K030597 · Synthes (Usa) · Mar 2003
SMALL TITANIUM WRIST FUSION PLATE
K023879 · Synthes (Usa) · Feb 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
K023802 · Synthes (Usa) · Jan 2003
BIOMET CALCANEAL PLATE
K022515 · Biomet Orthopedics, Inc. · Sep 2002
HALLU PLATES
K021626 · New Deal, S.A. · Aug 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255 · Synthes (Usa) · Jul 2002