Cleared Traditional

K083144 - ACUMED CLAVICLE SCREW SYSTEM

K083144 is an FDA 510(k) clearance for ACUMED CLAVICLE SCREW SYSTEM, manufactured by Acumed, LLC. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K083144 · Acumed, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
236d
Days
Class 2
Risk

K083144 is an FDA 510(k) clearance for the ACUMED CLAVICLE SCREW SYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on June 16, 2009 after a review of 236 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Acumed, LLC devices

FDA 510(k) Submission Details - K083144

510(k) Number K083144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2008
Decision Date June 16, 2009
Days to Decision 236 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
114d slower than avg
Panel avg: 122d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JDW Pin, Fixation, Threaded

All 84
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K083144.
ROCKWOOD CLAVICLE PINS
K103001 · DePuy Orthopaedics, Inc. · Feb 2011
TWISTCUT ENDOSORB SCREWS
K102777 · Merete Medical GmbH · Dec 2010
PROTOE ENDOSORB SMALL HAMMER TOE PIN
K100414 · Merete Medical GmbH · Jul 2010
NEXFIX COMPRESSION PIN
K072710 · Nexa Orthopedics, Inc. · Nov 2007
SBI TITANIUM THREADED PIN
K071540 · Small Bone Innovations, Inc. · Aug 2007
PIN SCREW
K061599 · Bk Meditech, Co., Ltd. · Jul 2006