Cleared Traditional

K002605 - 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW

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

K002605 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K002605

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.

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 81
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