Cleared Traditional

K002605 - 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW

K002605 is the FDA 510(k) clearance for 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002605 · Synthes (Usa) · Orthopedic device
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Nov 2000
Decision
90d
Days
Class 2
Risk

K002605 is an FDA 510(k) clearance for the 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on November 20, 2000 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) devices

Submission Details

510(k) Number K002605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2000
Decision Date November 20, 2000
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.

Device Classification

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 52
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K002605.
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · Stryker Endoscopy · Jul 2001
RESORBABLE HAMMERTOE PIN
K011137 · Biomet, Inc. · Jun 2001
APEX FIXATION PINS
K011136 · Howmedica Osteonics Corp. · May 2001
BIOMET LATERAL TROCH PLATE
K003294 · Biomet, Inc. · Nov 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · Biomet, Inc. · Nov 2000
SYNTHES SACRAL BAR SYSTEM
K001720 · Synthes (Usa) · Aug 2000