Cleared Traditional

WOLF LONG BONE PLATE SYSTEM (K131834) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131834 · Toby Orthopaedics · Orthopedic device
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Nov 2013
Decision
137d
Days
Class 2
Risk

K131834 is an FDA 510(k) clearance for the WOLF LONG BONE 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 Toby Orthopaedics (Miami, US). The FDA issued a Cleared decision on November 4, 2013 after a review of 137 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 Toby Orthopaedics devices

Submission Details

510(k) Number K131834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2013
Decision Date November 04, 2013
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K131834.
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · Smith & Nephew, Inc. · Feb 2014
D-RAD SMART PACK
K132296 · Smith & Nephew, Inc. · Jan 2014
ZIMMER DISTAL RADIUS PLATING SYSTEM
K133246 · Zimmer, Inc. · Dec 2013
2.5MM INLINE FUSION PLATE
K131867 · Biomet, Inc. · Oct 2013
ARTHREX COMPRESSION PLATES
K130510 · Arthrex, Inc. · Sep 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · Arthrex, Inc. · Jul 2013