Cleared Traditional

K960692 - SUBTALAR MBA SYSTEM

K960692 is an FDA 510(k) clearance for SUBTALAR MBA SYSTEM, manufactured by Kinetikos Medical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K960692 · Kinetikos Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
154d
Days
Class 2
Risk

K960692 is an FDA 510(k) clearance for the SUBTALAR MBA SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Kinetikos Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on July 23, 1996 after a review of 154 days - an extended review cycle.

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. Standard predicate reliance. 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 Kinetikos Medical, Inc. devices

FDA 510(k) Submission Details - K960692

510(k) Number K960692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date July 23, 1996
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 741
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K960692.
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960940 · Linvatec Corp. · Aug 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
K961413 · Synthes (Usa) · Aug 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
K962011 · Synthes (Usa) · Aug 1996
ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
K961649 · Smith & Nephew Endoscopy, Inc. · Jul 1996
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
K961234 · Depuy, Inc. · Jun 1996
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704 · Depuy, Inc. · Jun 1996