Cleared Special

K051063 - POLYAXIAL HEMISPHERICAL SPINAL SCREWS

K051063 is an FDA 510(k) clearance for POLYAXIAL HEMISPHERICAL SPINAL SCREWS, manufactured by Scient'X. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 27-day FDA review.

K051063 · Scient'X · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
27d
Days
Class 2
Risk

K051063 is an FDA 510(k) clearance for the POLYAXIAL HEMISPHERICAL SPINAL SCREWS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Scient'X (Round Rock, US). The FDA issued a Cleared decision on May 23, 2005 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scient'X devices

FDA 510(k) Submission Details - K051063

510(k) Number K051063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date May 23, 2005
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 206
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K051063.
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
K052761 · Stryker Spine · Oct 2005
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
K052317 · Stryker Spine · Sep 2005
S4 SPINAL SYSTEM
K050979 · Aesculap, Inc. · Jul 2005
CD HORIZON SPINAL SYSTEM
K050981 · Medtronic Sofamor Danek USA, Inc. · May 2005
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
K050675 · Depuy Spine, Inc. · Apr 2005
EASYSPINE SYSTEM
K043094 · Ldr Spine USA · Feb 2005