Cleared Traditional

K032269 - SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROX...

K032269 is the FDA 510(k) clearance for SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROX... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K032269 · Synthes (Usa) · Orthopedic device
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Sep 2003
Decision
56d
Days
Class 2
Risk

K032269 is an FDA 510(k) clearance for the SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES. 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 17, 2003 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 K032269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2003
Decision Date September 17, 2003
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 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 K032269.
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559 · Synthes (Usa) · Oct 2003
KLS-MARTIN STERNAL PLATING SYSTEM
K032413 · KLS-Martin L.P. · Oct 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187 · Arthrex, Inc. · Sep 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032 · Synthes (Usa) · Sep 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677 · Synthes (Usa) · Aug 2003
TEXAS T - PLATE
K031334 · Biomet, Inc. · May 2003