Cleared Traditional

K960307 - INDEX SHOE

K960307 is an FDA 510(k) clearance for INDEX SHOE, manufactured by Orthopedic Technology Research, Inc.. The device is a Class 2 Physical Medicine device with product code IRN cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K960307 · Orthopedic Technology Research, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
157d
Days
Class 2
Risk

K960307 is an FDA 510(k) clearance for the INDEX SHOE. Classified as Device, Warning, Overload, External Limb, Powered (product code IRN), Class II - Special Controls.

Submitted by Orthopedic Technology Research, Inc. (Sacramento, US). The FDA issued a Cleared decision on June 27, 1996 after a review of 157 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5575 - the FDA physical medicine device 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K960307

510(k) Number K960307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date June 27, 1996
Days to Decision 157 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 116d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRN Device Classification - Class 2, Special Controls

Product Code IRN Device, Warning, Overload, External Limb, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5575
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IRN Device, Warning, Overload, External Limb, Powered

All 9
Devices cleared under the same product code (IRN) and FDA review panel - the closest regulatory comparables to K960307.
SMARTSTEP SYSTEM
K023161 · Andante Medical Device, Ltd. · Dec 2002
ACCUTRED SHOE
K991313 · Orthopedic Technology Research, Inc. · Jun 1999
FOOT WEIGHT ALARM
K962591 · Cleveland Medical Devices, Inc. · Dec 1996
FORCEGUARD
K955034 · Impact Monitors, Inc. · Apr 1996
PED ALERT
K950656 · Orbitec Technologies Corp. · Oct 1995
SAFE-STEP
K931517 · Lenjoy Engineering, Inc. · Mar 1995
K960307 · INDEX SHOE
Download PDF FDA Summary Orthopedic Technology…