Cleared Traditional

K001941 - SYNTHES MODULAR FOOT SYSTEM

K001941 is the FDA 510(k) clearance for SYNTHES MODULAR FOOT SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K001941 · Synthes (Usa) · Orthopedic device
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Sep 2000
Decision
88d
Days
Class 2
Risk

K001941 is an FDA 510(k) clearance for the SYNTHES MODULAR FOOT 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 Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on September 22, 2000 after a review of 88 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 K001941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2000
Decision Date September 22, 2000
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K001941.
PE.R.I. II KNEE FRACTURE SYSTEM
K003235 · DePuy Orthopaedics, Inc. · Nov 2000
SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
K002361 · Synthes (Usa) · Oct 2000
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
K002710 · Synthes (Usa) · Sep 2000
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
K001945 · Synthes (Usa) · Sep 2000
LACTOSORB PANELS AND FASTENERS
K984390 · Biomet, Inc. · Aug 2000
SYNTHES (USA) ORIBITAL MESH PLATES
K001311 · Synthes (Usa) · Jun 2000