Cleared Traditional

K133668 - AFT GREATER TUBEROSITY FRACTURE PLATE

K133668 is the FDA 510(k) clearance for AFT GREATER TUBEROSITY FRACTURE PLATE by Shoulder Options, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K133668 · Shoulder Options, Inc. · Orthopedic device
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Mar 2014
Decision
94d
Days
Class 2
Risk

K133668 is an FDA 510(k) clearance for the AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE .... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Shoulder Options, Inc. (Waxhaw, US). The FDA issued a Cleared decision on March 3, 2014 after a review of 94 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 Shoulder Options, Inc. devices

Submission Details

510(k) Number K133668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2013
Decision Date March 03, 2014
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 895
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K133668.
AAP LOQTEC(R) OLECRANON PLATE
K140607 · Aap Implantate AG · May 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · Smith & Nephew, Inc. · May 2014
MATRIXRIB FIXATION SYSTEM
K133616 · Synthes USA Products, LLC · May 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715 · Wrightmedicaltechnologyinc · Feb 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · Smith & Nephew, Inc. · Feb 2014
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
K133675 · Aap Implantate AG · Jan 2014