Cleared Traditional

K010518 - SYNTHES ANTEROLATERAL CALCANEAL PLATE

K010518 is the FDA 510(k) clearance for SYNTHES ANTEROLATERAL CALCANEAL PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010518 · Synthes (Usa) · Orthopedic device
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May 2001
Decision
90d
Days
Class 2
Risk

K010518 is an FDA 510(k) clearance for the SYNTHES ANTEROLATERAL CALCANEAL PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 23, 2001 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

Submission Details

510(k) Number K010518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2001
Decision Date May 23, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple 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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 276
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K010518.
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · Synthes (Usa) · Jun 2001
EBI XFIX ACCESS PELVIC FIXATOR
K011697 · Ebi, L.P. · Jun 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · Synthes (Usa) · Jun 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344 · Synthes (Usa) · May 2001
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
K010437 · Ebi, L.P. · Mar 2001
COLLES C SERIES FRAME STERILE PACK
K003397 · DePuy Orthopaedics, Inc. · Jan 2001