Cleared Traditional

K162179 - osteo-WEDGE II Open Wedge Bone Locking ...

K162179 is an FDA 510(k) clearance for osteo-WEDGE II Open Wedge Bone Locking ..., manufactured by Graham Medical Technologies, LLC Dba Gramedica. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K162179 · Graham Medical Technologies, LLC Dba Gramedica · Orthopedic device
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Jan 2017
Decision
159d
Days
Class 2
Risk

K162179 is an FDA 510(k) clearance for the osteo-WEDGE II ® Open Wedge Bone Locking 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 Graham Medical Technologies, LLC Dba Gramedica (Macomb, US). The FDA issued a Cleared decision on January 10, 2017 after a review of 159 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 Graham Medical Technologies, LLC Dba Gramedica devices

FDA 510(k) Submission Details - K162179

510(k) Number K162179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2016
Decision Date January 10, 2017
Days to Decision 159 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 slower than avg
Panel avg: 122d · This submission: 159d
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 1043
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