Cleared Traditional

K052847 - CAPLESS PEDICLE SCREW SYSTEM

K052847 is the FDA 510(k) clearance for CAPLESS PEDICLE SCREW SYSTEM by X-Spine Systems, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K052847 · X-Spine Systems, Inc. · Orthopedic device
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Dec 2005
Decision
66d
Days
Class 2
Risk

K052847 is an FDA 510(k) clearance for the CAPLESS PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on December 12, 2005 after a review of 66 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. 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.

View all X-Spine Systems, Inc. devices

Submission Details

510(k) Number K052847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2005
Decision Date December 12, 2005
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K052847.
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
K061978 · Ebi, L.P. · Aug 2006
MODIFICATION TO S4 SPINAL SYSTEM
K060152 · Aesculap, Inc. · Feb 2006
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483 · Medtronic Sofamor Danek · Jan 2006
XIA SPINAL SYSTEM
K053115 · Stryker Spine · Dec 2005
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
K052971 · Stryker Spine · Nov 2005
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
K052761 · Stryker Spine · Oct 2005