Cleared Traditional

K023013 - STRYKER XCEL ANCHOR SYSTEM

K023013 is an FDA 510(k) clearance for STRYKER XCEL ANCHOR SYSTEM, manufactured by Stryker Endoscopy. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K023013 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
169d
Days
Class 2
Risk

K023013 is an FDA 510(k) clearance for the STRYKER XCEL ANCHOR SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 169 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 Stryker Endoscopy devices

FDA 510(k) Submission Details - K023013

510(k) Number K023013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2002
Decision Date February 26, 2003
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K023013.
STRYKER BIOZIP SUTURE ANCHOR
K023192 · Stryker Endoscopy · Mar 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · KARL STORZ Endoscopy-America, Inc. · Mar 2003
EBI DYNAFIX COMPRESSION BONE SCREW
K030706 · Ebi, L.P. · Mar 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · Biomet Orthopedics, Inc. · Jan 2003
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · Howmedica Osteonics Corp. · Dec 2002
AAP CANNULATED SCREWS
K021233 · Aap Implantate AG · Dec 2002