Cleared Traditional

K040588 - SYNTHES (USA) 2.4 MM LCP WRIST PLATE

K040588 is the FDA 510(k) clearance for SYNTHES (USA) 2.4 MM LCP WRIST PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K040588 · Synthes (Usa) · Orthopedic device
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May 2004
Decision
63d
Days
Class 2
Risk

K040588 is an FDA 510(k) clearance for the SYNTHES (USA) 2.4 MM LCP WRIST PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 7, 2004 after a review of 63 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 K040588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2004
Decision Date May 07, 2004
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K040588.
LCP RADIAL HEAD PLATING SYSTEM
K040777 · Synthes (Usa) · Jun 2004
INTEGRA BONE FIXATION SYSTEM
K040860 · Integra LifeSciences Corporation · Jun 2004
KLS MARTIN HAND PLATING SYSTEM
K040598 · KLS-Martin L.P. · May 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593 · Zimmer, Inc. · Apr 2004
EVOLVE RADIAL PLATE
K033456 · Wrightmedicaltechnologyinc · Jan 2004
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · Smith & Nephew, Inc. · Dec 2003