Cleared Traditional

K152062 - BIOFOAM Bone Wedge

K152062 is an FDA 510(k) clearance for BIOFOAM Bone Wedge, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K152062 · Wrightmedicaltechnologyinc · Orthopedic device
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May 2016
Decision
298d
Days
Class 2
Risk

K152062 is an FDA 510(k) clearance for the BIOFOAM Bone Wedge. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on May 17, 2016 after a review of 298 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K152062

510(k) Number K152062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2015
Decision Date May 17, 2016
Days to Decision 298 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
176d slower than avg
Panel avg: 122d · This submission: 298d
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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K152062.
NEOVIEW Plating System
K160995 · In2bones Sas · Jun 2016
AxSOS 3Ti
K153379 · Stryker GmbH · May 2016
OsteoMed ExtremiLOCK Wrist Plating System
K161041 · Osteomed · May 2016
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
K153716 · Gpc Medical, Ltd. · May 2016
Gridlock Ankle Plating System
K160177 · Trilliant Surgical, Ltd. · Apr 2016
MotoBand(TM) CP Implant System
K160300 · Crossroads Extremity Systems, LLC · Apr 2016