Cleared Traditional

K000558 - SYNTHES (USA) WRIST FUSION PLATES (WFP)

K000558 is the FDA 510(k) clearance for SYNTHES (USA) WRIST FUSION PLATES (WFP) by Synthes (Usa). It is a Class 2 Orthopedic device (product code LXT) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K000558 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
56d
Days
Class 2
Risk

K000558 is an FDA 510(k) clearance for the SYNTHES (USA) WRIST FUSION PLATES (WFP). Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 56 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 Synthes (Usa) devices

Submission Details

510(k) Number K000558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date April 14, 2000
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
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 - LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

All 33
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K000558.
SYNTHES SCALLOPED DISTAL TIBIA PLATE
K001793 · Synthes (Usa) · Aug 2000
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
K000972 · Synthes (Usa) · Jun 2000
HOFFMANN II EXTERNAL FIXATION SYSTEM
K000957 · Howmedica Osteonics Corp. · May 2000
ULTIMAX HAIG II NAIL SYSTEM
K991889 · Encore Orthopedics, Inc. · Aug 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407 · Synthes (Usa) · Jun 1999
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618 · Synthes (Usa) · Nov 1996