Cleared Traditional

K103513 - LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT

Also marketed or referenced as:
MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT ANTERIOR CLAVICLE PLA

K103513 is an FDA 510(k) clearance for LATERAL SUPERIOR CLAVICLE PLATE, manufactured by Advanced Orthopaedic Solutions, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K103513 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
328d
Days
Class 2
Risk

K103513 is an FDA 510(k) clearance for the LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Torrance, US). The FDA issued a Cleared decision on October 24, 2011 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Advanced Orthopaedic Solutions, Inc. devices

FDA 510(k) Submission Details - K103513

510(k) Number K103513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2010
Decision Date October 24, 2011
Days to Decision 328 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
206d slower than avg
Panel avg: 122d · This submission: 328d
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 1215
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K103513.
TRIMED CLAVICLE FIXATION SYSTEM
K112509 · TriMed, Inc. · Nov 2011
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K112174 · Zimmer, Inc. · Oct 2011
SYNTHES STERNAL FIXATION SYSTEM
K112689 · Synthes, Inc. · Oct 2011
OSTEOMED HAND FUSION SYSTEM
K111419 · Osteomed LP · Oct 2011
EASYLOCK OSTEOSYSTEM
K111266 · TriMed, Inc. · Oct 2011
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
K112455 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Sep 2011