Cleared Traditional

TEXAS SCOTTISH RITE EASY/LOCK FIXATOR (K931578) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931578 · Applied Osteo Systems, Inc. · Orthopedic device
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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

Submission Details

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.

Device Classification

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 29
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K931578.
MONOTUBE TUBE-TO-TUBE CLAMP
K954667 · Howmedica Corp. · Jan 1996
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · Howmedica Corp. · Sep 1995
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698 · Howmedica Corp. · Feb 1994
SYNTHES EXTERNAL FIXATION BONE CLIP
K894098 · Synthes (Usa) · Apr 1990
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397 · Howmedica Corp. · Aug 1985