Cleared Traditional

K932687 - AME(R) UNIVERSIAL CABLE SYSTEM

K932687 is an FDA 510(k) clearance for AME UNIVERSIAL 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 334-day FDA review.

K932687 · American Medical Electronics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
334d
Days
Class 2
Risk

K932687 is an FDA 510(k) clearance for the AME(R) UNIVERSIAL 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 May 3, 1994 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K932687

510(k) Number K932687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1993
Decision Date May 03, 1994
Days to Decision 334 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
212d slower than avg
Panel avg: 122d · This submission: 334d
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 K932687.
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
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
K935646 · Biodynamic Technologies, Inc. · Mar 1994
FX-CABLELOK CABLE/PLATE SYSTEM
K935950 · Buckman Co., Inc. · Mar 1994