Cleared Traditional

K960537 - K2 BONE SCREW SYSTEM

K960537 is an FDA 510(k) clearance for K2 BONE SCREW 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 47-day FDA review.

K960537 · Kinetikos Medical, Inc. · Orthopedic device
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Mar 1996
Decision
47d
Days
Class 2
Risk

K960537 is an FDA 510(k) clearance for the K2 BONE SCREW 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 March 25, 1996 after a review of 47 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K960537

510(k) Number K960537 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 07, 1996
Decision Date March 25, 1996
Days to Decision 47 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 122d · This submission: 47d
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 1054
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K960537.
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704 · Depuy, Inc. · Jun 1996
WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW
K961157 · Whiteside Biomechanics, Inc. · May 1996
K3 BONE SCREW SYSTEM
K960533 · Kinetikos Medical, Inc. · Mar 1996
NORTHO BONE SCREW
K925872 · Northo Orthopedics · Mar 1996
J.B.S. T.T.A SCREW
K955710 · J.B.S. (Usa), Inc. · Mar 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837 · Wrightmedicaltechnologyinc · Mar 1996
K960537 · K2 BONE SCREW SYSTEM
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