Cleared Traditional

K050461 - XIA 4.5 SPINAL SYSTEM

K050461 is an FDA 510(k) clearance for XIA 4.5 SPINAL SYSTEM, manufactured by Stryker Spine. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K050461 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
154d
Days
Class 2
Risk

K050461 is an FDA 510(k) clearance for the XIA 4.5 SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on July 27, 2005 after a review of 154 days - an extended review 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: 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 Stryker Spine devices

FDA 510(k) Submission Details - K050461

510(k) Number K050461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2005
Decision Date July 27, 2005
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 280
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K050461.
NV CORMED SOLAS SPINAL SYSTEM
K051959 · Nv Cormed · Oct 2005
ARCTEC SEMIRIGID PLATING SYSTEM
K051044 · Altiva Corp. · Oct 2005
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
K051697 · Medical Device Advisory Development Group · Sep 2005
HYDRALOK SYSTEM
K051216 · Altiva Corp. · Jul 2005
ZODIAC SPINAL FIXATION SYSTEM
K051286 · Alphatec/Nexmed · Jun 2005
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471 · Solco Biomedical Co., Ltd. · May 2005