Cleared Traditional

K950704 - K4 BONE SCREW SYSTEM

K950704 is an FDA 510(k) clearance for K4 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 135-day FDA review.

K950704 · Kinetikos Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
135d
Days
Class 2
Risk

K950704 is an FDA 510(k) clearance for the K4 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 June 30, 1995 after a review of 135 days - within the typical 510(k) review window.

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 - K950704

510(k) Number K950704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1995
Decision Date June 30, 1995
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 K950704.
DEPUY SET SCREW
K950833 · Depuy, Inc. · Jul 1995
ORTHOPEDIC SCREW FIXATION
K932350 · Osteomed Corp. · Jul 1995
HARPOON SUTURE ANCHORS
K943806 · Biomet, Inc. · Jul 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652 · Osteotech, Inc. · Jun 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · Synthes (Usa) · Jun 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · Smith & Nephew Richards, Inc. · Jun 1995