Cleared Traditional

K960539 - DIAO HAND SURGERY SET

K960539 is an FDA 510(k) clearance for DIAO HAND SURGERY SET, manufactured by Kinetikos Medical, Inc.. The device is a Class 1 Orthopedic device with product code HXB cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K960539 · Kinetikos Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
167d
Days
Class 1
Risk

K960539 is an FDA 510(k) clearance for the DIAO HAND SURGERY SET. Classified as Probe (product code HXB), Class I - General Controls.

Submitted by Kinetikos Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on July 23, 1996 after a review of 167 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 - K960539

510(k) Number K960539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1996
Decision Date July 23, 1996
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

HXB Device Classification - Class 1, General Controls

Product Code HXB Probe
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HXB Probe

All 10
Devices cleared under the same product code (HXB) and FDA review panel - the closest regulatory comparables to K960539.
FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
K912843 · Flexmedics · Sep 1991
SURGICAL PROBE
K890227 · Kinetic Medical Products · Jan 1989
BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375
K873651 · Arthropedics, Inc. · Nov 1987
HOOK PROBE #TM-1376
K873652 · Arthropedics, Inc. · Nov 1987
2.5MM & 4MM PROBE K841969-LABELING
K841971 · Stainless Mfg., Inc. · Jun 1984
SHUTT PRECISION PROBES
K840558 · Concept, Inc. · Apr 1984