Cleared Traditional

K931578 - TEXAS SCOTTISH RITE EASY/LOCK FIXATOR

K931578 is an FDA 510(k) clearance for TEXAS SCOTTISH RITE EASY/LOCK FIXATOR, manufactured by Applied Osteo Systems, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K931578 · Applied Osteo Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
329d
Days
Class 2
Risk

K931578 is an FDA 510(k) clearance for the TEXAS SCOTTISH RITE EASY/LOCK FIXATOR. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Applied Osteo Systems, Inc. devices

FDA 510(k) Submission Details - K931578

510(k) Number K931578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date February 22, 1994
Days to Decision 329 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
207d slower than avg
Panel avg: 122d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 59
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K931578.
EXTERNAL FIXATOR
K943857 · Acu Med, Inc. · Jan 1995
ACE PELVIC STABILIZER
K933968 · Ace Medical Co. · Jun 1994
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698 · Howmedica Corp. · Feb 1994
HOWMEDICA MONOTUBE T-CONNECTOR
K936124 · Howmedica, Inc. · Feb 1994
ACE OPEN-BACK HALO RING
K914858 · Ace Medical Co. · Nov 1991