Cleared Traditional

K132910 - DEPUY SYNTHES SPINE DENS ACCESS SYSTEM

K132910 is an FDA 510(k) clearance for DEPUY SYNTHES SPINE DENS ACCESS SYSTEM, manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K132910 · Synthes USA Products, LLC · Orthopedic device
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Dec 2013
Decision
90d
Days
Class 2
Risk

K132910 is an FDA 510(k) clearance for the DEPUY SYNTHES SPINE DENS ACCESS SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on December 16, 2013 after a review of 90 days - within the typical 510(k) review window.

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 Synthes USA Products, LLC devices

FDA 510(k) Submission Details - K132910

510(k) Number K132910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2013
Decision Date December 16, 2013
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 951
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K132910.
CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
K130613 · Laura Cattabriga · Jan 2014
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
K133440 · Stryker Trauma AG · Dec 2013
APTUS CANNULATED COMPRESSION SCREWS
K133460 · Medartis AG · Dec 2013
NORMED PELLEGRIN CALCANEUS STOP SCREW
K133035 · Normed Medizin-Technik GmbH · Dec 2013
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
K131591 · Pega Medical, Inc. · Nov 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · Arthrex, Inc. · Nov 2013