Cleared Traditional

K020097 - STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM

K020097 is an FDA 510(k) clearance for STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM, manufactured by Stryker Endoscopy. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K020097 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
64d
Days
Class 2
Risk

K020097 is an FDA 510(k) clearance for the STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on March 15, 2002 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Endoscopy devices

FDA 510(k) Submission Details - K020097

510(k) Number K020097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2002
Decision Date March 15, 2002
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 59
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K020097.
JET-X HA COATED HALF PINS
K023921 · Smith & Nephew, Inc. · Feb 2003
JET-X TIN COATED HALF PINS
K023134 · Smith & Nephew, Inc. · Oct 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182 · Biomet, Inc. · May 2002
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · Stryker Endoscopy · Sep 2001
MODIFICATION TO THE TAC' PIN
K011875 · New Deal, S.A. · Sep 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · Stryker Endoscopy · Jul 2001