Cleared Traditional

K040022 - STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM

K040022 is an FDA 510(k) clearance for STRYKER LEIBINGER UNIVERSAL DISTAL RADI..., manufactured by Stryker Leibinger. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K040022 · Stryker Leibinger · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
65d
Days
Class 2
Risk

K040022 is an FDA 510(k) clearance for the STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on March 12, 2004 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Leibinger devices

FDA 510(k) Submission Details - K040022

510(k) Number K040022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2004
Decision Date March 12, 2004
Days to Decision 65 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1096
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K040022.
KLS MARTIN HAND PLATING SYSTEM
K040598 · KLS-Martin L.P. · May 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
K040588 · Synthes (Usa) · May 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593 · Zimmer, Inc. · Apr 2004
TRIMED BEARING PLATE
K040112 · Tri-Med, Inc. · Mar 2004
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
K031961 · Inion , Ltd. · Mar 2004
TRIMED RADIAL BULLET
K030877 · Tri-Med, Inc. · Feb 2004