Cleared Traditional

K011978 - SYNTHES LCP PROXIMAL TIBIA PLATE

K011978 is the FDA 510(k) clearance for SYNTHES LCP PROXIMAL TIBIA PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K011978 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2001
Decision
45d
Days
Class 2
Risk

K011978 is an FDA 510(k) clearance for the SYNTHES LCP PROXIMAL TIBIA 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 August 9, 2001 after a review of 45 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 K011978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2001
Decision Date August 09, 2001
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
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 K011978.
CONGRUENT BONE PLATE SYSTEM
K012655 · Acu Med, Inc. · Nov 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114 · Synthes (Usa) · Sep 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · Howmedica Osteonics Corp. · Aug 2001
WUJIN #3 FEMORAL BONE PLATE
K011459 · Biopro, Inc. · Aug 2001
WUJIN #3 TIBIAL BONE PLATE
K011460 · Biopro, Inc. · Aug 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · Synthes (Usa) · Jul 2001