Cleared Traditional

K022231 - NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM

K022231 is an FDA 510(k) clearance for NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM, manufactured by Osteomedics, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K022231 · Osteomedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
65d
Days
Class 2
Risk

K022231 is an FDA 510(k) clearance for the NORMED DISTAL RADIUS RECONSTRUCTION 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 Osteomedics, Inc. (Paramus, US). The FDA issued a Cleared decision on September 13, 2002 after a review of 65 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.

FDA 510(k) Submission Details - K022231

510(k) Number K022231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2002
Decision Date September 13, 2002
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 1331
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K022231.
HIP TOOL IMPLANT
K022139 · Orthopedic Sciences, Inc. · Sep 2002
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
K022324 · Osteomedics, Inc. · Sep 2002
BIOMET CALCANEAL PLATE
K022515 · Biomet Orthopedics, Inc. · Sep 2002
NORMED MINI EXTERNAL FIXATOR SYSTEM
K022230 · Osteomedics, Inc. · Sep 2002
NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
K022323 · Osteomedics, Inc. · Sep 2002
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
K022325 · Osteomedics, Inc. · Sep 2002
K022231 · NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
Download PDF FDA Summary Osteomedics, Inc.