Cleared Traditional

K153374 - CARE BRAND Locking Bone Plates and Scre...

K153374 is an FDA 510(k) clearance for CARE BRAND Locking Bone Plates and Scre..., manufactured by Orthocare. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K153374 · Orthocare · Orthopedic device
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Jun 2016
Decision
207d
Days
Class 2
Risk

K153374 is an FDA 510(k) clearance for the CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthocare (New Delhi, IN). The FDA issued a Cleared decision on June 17, 2016 after a review of 207 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 Orthocare devices

FDA 510(k) Submission Details - K153374

510(k) Number K153374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2015
Decision Date June 17, 2016
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
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
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K153374.
Tarsa-Link Stand-Alone Wedge Fixation System
K161037 · Life Spine, Inc. · Aug 2016
ARIX Foot System
K161864 · Jeil Medical Corporation · Aug 2016
Biomet Microfixation Sternal Closure System
K161896 · Biomet Microfixation · Aug 2016
NEOVIEW Plating System
K160995 · In2bones Sas · Jun 2016
AxSOS 3Ti
K153379 · Stryker GmbH · May 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016