Cleared Traditional

K942300 - SILKON TITANIUM CABLE SYSTEM

K942300 is an FDA 510(k) clearance for SILKON TITANIUM CABLE SYSTEM, manufactured by American Medical Electronics, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K942300 · American Medical Electronics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
242d
Days
Class 2
Risk

K942300 is an FDA 510(k) clearance for the SILKON TITANIUM CABLE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by American Medical Electronics, Inc. (Richardson, US). The FDA issued a Cleared decision on January 9, 1995 after a review of 242 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 American Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K942300

510(k) Number K942300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 12, 1994
Decision Date January 09, 1995
Days to Decision 242 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
120d slower than avg
Panel avg: 122d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 117
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K942300.
CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK
K950027 · Intermedics Orthopedics · Mar 1995
CABLE-EASE PLATE AND CABLE SYSTEM
K944529 · Intermedics Orthopedics · Feb 1995
CCG CERCLAGE SYSTEM
K932024 · Encore Orthopedics, Inc. · Feb 1995
PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES
K940729 · Pioneer Surgical Technology · Dec 1994
DALL MILES SYSTEM GROOVED BUTTON
K934059 · Howmedica Corp. · Aug 1994
SONGER CABLE SYSTEM
K941213 · Pioneer Surgical Technology · Apr 1994