Cleared Traditional

K965221 - RANSFORD CERVICAL FIXATION SYSTEM

K965221 is the FDA 510(k) clearance for RANSFORD CERVICAL FIXATION SYSTEM by Surgicraft , Ltd.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K965221 · Surgicraft , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
219d
Days
Class 2
Risk

K965221 is an FDA 510(k) clearance for the RANSFORD CERVICAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Surgicraft , Ltd. (Redditch, Worcestershire, GB). The FDA issued a Cleared decision on August 7, 1997 after a review of 219 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Surgicraft , Ltd. devices

Submission Details

510(k) Number K965221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1996
Decision Date August 07, 1997
Days to Decision 219 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
97d slower than avg
Panel avg: 122d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 260
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K965221.
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358 · Synthes (Usa) · Apr 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K974573 · Depuy, Inc. · Feb 1998
CD SPINAL SYSTEM
K964159 · Sofamor Danek USA,Inc. · Oct 1997
EMPOWER ANTERIOR DIRECT SCREWS
K965224 · Smith & Nephew Richards, Inc. · May 1997
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
K964254 · Sofamor Danek USA,Inc. · Apr 1997
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024 · Depuy, Inc. · Mar 1997