Cleared Traditional

K951303 - SFC

K951303 is an FDA 510(k) clearance for SFC, manufactured by Medpac. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K951303 · Medpac · Orthopedic device
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Jun 1995
Decision
97d
Days
Class 2
Risk

K951303 is an FDA 510(k) clearance for the SFC. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medpac (Valencia, US). The FDA issued a Cleared decision on June 27, 1995 after a review of 97 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 Medpac devices

FDA 510(k) Submission Details - K951303

510(k) Number K951303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1995
Decision Date June 27, 1995
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
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 1017
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K951303.
LMT BONE ANCHOR
K951233 · Li Medical Technologies, Inc. · Jul 1995
LMT BONE ANCHOR
K951472 · Li Medical Technologies, Inc. · Jul 1995
K4 BONE SCREW SYSTEM
K950704 · Kinetikos Medical, Inc. · Jun 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