Cleared Abbreviated

K011458 - SYNTHES STRAIGHT WRIST FUSION PLATE

K011458 is the FDA 510(k) clearance for SYNTHES STRAIGHT WRIST FUSION PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code KTW) cleared through the Abbreviated 510(k) pathway after a 83-day FDA review.

K011458 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
83d
Days
Class 2
Risk

K011458 is an FDA 510(k) clearance for the SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on August 2, 2001 after a review of 83 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Synthes (Usa) devices

Submission Details

510(k) Number K011458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2001
Decision Date August 02, 2001
Days to Decision 83 days
Submission Type Abbreviated
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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 22
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K011458.
LEFORTE SYSTEM BONE PLATE
K023360 · Jeil Medical Corporation · Oct 2002
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645 · Alliance Medical Corp. · Jun 2002
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · Synthes (Usa) · Sep 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · Synthes (Usa) · May 2001
STRYKER TRAUMA PELVIC SET
K001614 · Howmedica Osteonics Corp. · Aug 2000
SAMARCO SPIDER PLATES
K001271 · Biomet, Inc. · Jul 2000