Cleared Traditional

K920608 - AMERICA SYSTEM

K920608 is an FDA 510(k) clearance for AMERICA SYSTEM, manufactured by I. Klimov Co.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K920608 · I. Klimov Co. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
129d
Days
Class 2
Risk

K920608 is an FDA 510(k) clearance for the AMERICA SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by I. Klimov Co. (Philadelphia, US). The FDA issued a Cleared decision on June 19, 1992 after a review of 129 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.

FDA 510(k) Submission Details - K920608

510(k) Number K920608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date June 19, 1992
Days to Decision 129 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 392
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K920608.
OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION
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INTRAMEDULLARY HIP SCREW
K921786 · Smith & Nephew Richards, Inc. · Jul 1992
MONOTUBE EXTERNAL FIXATION SYSTEM
K910483 · Howmedica Corp. · Jul 1992
RIHARDS TITANIUM HALF PIN
K920024 · Smith & Nephew Richards, Inc. · Jan 1992
HOFFMANN DYNAMIC WRIST FIXATOR
K910986 · Howmedica Corp. · Jan 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · Synthes (Usa) · Jan 1992