Cleared Traditional

K930531 - AME(R) RIGID FIXATION SYSTEM

K930531 is an FDA 510(k) clearance for AME RIGID FIXATION SYSTEM, manufactured by American Medical Electronics, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K930531 · American Medical Electronics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
364d
Days
Class 2
Risk

K930531 is an FDA 510(k) clearance for the AME(R) RIGID FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by American Medical Electronics, Inc. (Concord, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K930531

510(k) Number K930531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1993
Decision Date February 01, 1994
Days to Decision 364 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
242d slower than avg
Panel avg: 122d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 399
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K930531.
LOW PROFILE MID CROSS BRACING
K931225 · Advanced Spine Fixation Systems, Inc. · May 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891 · Synthes (Usa) · Apr 1994
LOW PROFILE SLEAVE NUT ASSEMBLY
K931208 · Advanced Spine Fixation Systems, Inc. · Mar 1994
SENTRY POSTERIOR SPINAL SYSTEM
K930710 · Sofamor Danek Mfg., Inc. · Oct 1993
SELBY INSTRUMENTATION
K924474 · Advanced Spine Fixation Systems, Inc. · Sep 1993
COTREL - DUBOUSSET SPINE IMPLANTS
K921056 · Buckman Co., Inc. · Jun 1993