Cleared Traditional

K914546 - ANGLED BLADE PLATE

K914546 is the FDA 510(k) clearance for ANGLED BLADE PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code KTW) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K914546 · Synthes (Usa) · Orthopedic device
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Nov 1991
Decision
49d
Days
Class 2
Risk

K914546 is an FDA 510(k) clearance for the ANGLED BLADE PLATE. 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 November 29, 1991 after a review of 49 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 K914546 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 11, 1991
Decision Date November 29, 1991
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
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 22
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K914546.
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289 · Synthes (Usa) · Nov 1995
MALLEOLAR SCREW
K931686 · Onyx Medical Corp. · Apr 1994
TORUS EXTERNAL FIXATION SYSTEM
K925635 · Zimmer, Inc. · Jun 1993
LEVTECH SMALL BONE PLATE
K893928 · Buckman Co., Inc. · Nov 1989
ACROMED ADS BONE NAIL
K862552 · Buckman Co., Inc. · Sep 1986
ORTHOPEDIC FIXATION DEVICES
K821566 · Howmedica Corp. · Jun 1982