Cleared Traditional

K141527 - DEPUY SYNTHES VARIABLE ANGLE LOCKING HA...

K141527 is the FDA 510(k) clearance for DEPUY SYNTHES VARIABLE ANGLE LOCKING HA... by Synthes (Usa). It is a Class 2 Orthopedic device (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

Submission Details

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.

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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141527.
APTUS Foot System
K142581 · Medartis AG · Apr 2015
Acumed Ankle Plating System
K143385 · Acumed, LLC · Apr 2015
Arthrex Distal Radius System
K143749 · Arthrex, Inc. · Apr 2015
Tarsa-Link Wedge Fixation System
K150368 · Life Spine · Mar 2015
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
K150099 · Synthes USA Products, LLC · Mar 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331 · Zimmer, Inc. · Mar 2015