Cleared Special

K041310 - STRYKER WEDGE SUTURE ANCHOR SYSTEM

K041310 is an FDA 510(k) clearance for STRYKER WEDGE SUTURE ANCHOR SYSTEM, manufactured by Stryker Endoscopy. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 28-day FDA review.

K041310 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
28d
Days
Class 2
Risk

K041310 is an FDA 510(k) clearance for the STRYKER WEDGE SUTURE ANCHOR SYSTEM. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on June 14, 2004 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K041310

510(k) Number K041310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2004
Decision Date June 14, 2004
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 603
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K041310.
TI - SCREW ANCHOR SP
K042460 · Arthrotek, Inc. · Oct 2004
SUPER REVO HERCULINE SUTURE ANCHOR
K041713 · Linvatec Corp. · Jul 2004
OPUS MAGNUM ANCHOR WITH INSERTER
K041440 · Opus Medical, Inc. · Jun 2004
FEMORAL HOOK
K041261 · Arthrotek, Inc. · Jun 2004
TITANIUM TOGGLE BUTTON(S)
K033838 · Biomet Manufacturing, Inc. · Feb 2004
ADHOC CLAW
K023963 · Future Medical Systems, Inc. · May 2003
K041310 · STRYKER WEDGE SUTURE ANCHOR SYSTEM
Download PDF FDA Summary Stryker Endoscopy