Cleared Traditional

K943853 - DISTAL RADIUS FRACTURE FIXATION PLATE S...

K943853 is the FDA 510(k) clearance for DISTAL RADIUS FRACTURE FIXATION PLATE S... by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K943853 · Wrightmedicaltechnologyinc · Orthopedic device
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Jan 1995
Decision
165d
Days
Class 2
Risk

K943853 is an FDA 510(k) clearance for the DISTAL RADIUS FRACTURE FIXATION PLATE 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 Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 165 days - an extended review 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: 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K943853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1994
Decision Date January 20, 1995
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
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 946
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K943853.
BONE PLATE SYSTEM
K942359 · Acu Med, Inc. · Apr 1995
LUHR(R) TITANIUM ALLOY BURR HOLE COVERS
K950105 · Howmedica Corp. · Apr 1995
LUHR(R) TITANIUM BURR HOLE COVERS
K950115 · Howmedica, Inc. · Apr 1995
PELVIC RADIUS PLATE
K936233 · Smith & Nephew Richards, Inc. · Aug 1994
VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
K930480 · Smith & Nephew Richards, Inc. · Jun 1994
SPOON PLATE
K931690 · Onyx Medical Corp. · Jun 1994