Cleared Traditional

PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) (K081608) - FDA 510(k) Clearance

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

K081608 · Toby Orthopaedics, LLC · Orthopedic device
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Dec 2008
Decision
193d
Days
Class 2
Risk

K081608 is an FDA 510(k) clearance for the PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS). 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, LLC (Miami, US). The FDA issued a Cleared decision on December 19, 2008 after a review of 193 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 Toby Orthopaedics, LLC devices

Submission Details

510(k) Number K081608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2008
Decision Date December 19, 2008
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
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 K081608.
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
K083025 · Synthes (Usa) · Jan 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032 · Smith & Nephew, Inc. · Jan 2009
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K083213 · Synthes (Usa) · Dec 2008
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
K082527 · Zimmer, Inc. · Dec 2008
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
K082625 · Synthes (Usa) · Dec 2008
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424
K083364 · DePuy Orthopaedics, Inc. · Dec 2008