Cleared Special

K052971 - STRYKER SPINE TRIO SPINAL FIXATION SYSTEM

K052971 is the FDA 510(k) clearance for STRYKER SPINE TRIO SPINAL FIXATION SYSTEM by Stryker Spine. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 23-day FDA review.

K052971 · Stryker Spine · Orthopedic device
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Nov 2005
Decision
23d
Days
Class 2
Risk

K052971 is an FDA 510(k) clearance for the STRYKER SPINE TRIO SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on November 16, 2005 after a review of 23 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 Stryker Spine devices

Submission Details

510(k) Number K052971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2005
Decision Date November 16, 2005
Days to Decision 23 days
Submission Type Special
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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 K052971.
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483 · Medtronic Sofamor Danek · Jan 2006
CAPLESS PEDICLE SCREW SYSTEM
K052847 · X-Spine Systems, Inc. · Dec 2005
XIA SPINAL SYSTEM
K053115 · Stryker Spine · Dec 2005
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