Cleared Traditional

SYNTHES LCP PROXIMAL HUMERUS PLATES (K011815) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011815 · Synthes (Usa) · Orthopedic device
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Sep 2001
Decision
87d
Days
Class 2
Risk

K011815 is an FDA 510(k) clearance for the SYNTHES LCP PROXIMAL HUMERUS PLATES. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 87 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 K011815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2001
Decision Date September 06, 2001
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 37
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K011815.
PK High Tibial Osteotomy Correction System
K182285 · Paonan Biotech Co., Ltd. · Jun 2019
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
K080109 · Synthes (Usa) · Mar 2008
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · Synthes (Usa) · Aug 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · Synthes (Usa) · May 2001
STRYKER TRAUMA PELVIC SET
K001614 · Howmedica Osteonics Corp. · Aug 2000
SAMARCO SPIDER PLATES
K001271 · Biomet, Inc. · Jul 2000