Cleared Traditional

K101240 - CLOSED FUSION PLATE

Also marketed or referenced as:
824677021, 22, 824071001, 824071101, 824671001, 82467

K101240 is an FDA 510(k) clearance for CLOSED FUSION PLATE, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K101240 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
80d
Days
Class 2
Risk

K101240 is an FDA 510(k) clearance for the CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 80 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K101240

510(k) Number K101240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2010
Decision Date July 23, 2010
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K101240.
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
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SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776 · Synthes (Usa) · Aug 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708
K101421 · DePuy Orthopaedics, Inc. · Jun 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240 · OrthoPediatrics Corp. · May 2010
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
K100271 · Howmedica Osteonics Corp. · May 2010