Cleared Traditional

K112923 - SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM

K112923 is an FDA 510(k) clearance for SUSPENSION CLAVICLE FRACTURE FIXATION S..., manufactured by Suspension Orthopaedic Solutions, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K112923 · Suspension Orthopaedic Solutions, LLC · Orthopedic device
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Dec 2011
Decision
85d
Days
Class 2
Risk

K112923 is an FDA 510(k) clearance for the SUSPENSION CLAVICLE FRACTURE FIXATION 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 Suspension Orthopaedic Solutions, LLC (Shelton, US). The FDA issued a Cleared decision on December 27, 2011 after a review of 85 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 Suspension Orthopaedic Solutions, LLC devices

FDA 510(k) Submission Details - K112923

510(k) Number K112923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date December 27, 2011
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 1055
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K112923.
MAXLOCK EXTREME SYSTEM
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K113718 · Zimmer GmbH · Jan 2012
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K112169 · Medartis AG · Jan 2012
STRYKER RESORBABLE FIXATION SYSTEM
K113109 · Stryker · Dec 2011
AXSOS LOCKING PLATE SYSTEM
K112926 · Stryker Corp. · Dec 2011
APTUS(R) DISTAL HUMERUS SYSTEM
K112560 · Medartis AG · Dec 2011