Cleared Traditional

K141527 - DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM

K141527 is an FDA 510(k) clearance for DEPUY SYNTHES VARIABLE ANGLE LOCKING HA..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K141527 · Synthes (Usa) · Orthopedic device
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Mar 2015
Decision
294d
Days
Class 2
Risk

K141527 is an FDA 510(k) clearance for the DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND 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 Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 30, 2015 after a review of 294 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K141527

510(k) Number K141527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2014
Decision Date March 30, 2015
Days to Decision 294 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
172d slower than avg
Panel avg: 122d · This submission: 294d
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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141527.
Acumed Ankle Plating System
K143385 · Acumed, LLC · Apr 2015
Airlock osteosynthesis plate system
K143523 · Novastep · Apr 2015
Arthrex Distal Radius System
K143749 · Arthrex, Inc. · Apr 2015
Eminent Foot Plate System
K143365 · Eminent Spine · Mar 2015
Biomet Proximal Humerus Plating System
K143697 · Biomet Manufacturing · Mar 2015
Tarsa-Link Wedge Fixation System
K150368 · Life Spine · Mar 2015