Cleared Traditional

K050997 - EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE

K050997 is an FDA 510(k) clearance for EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE, manufactured by Flexuspine, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K050997 · Flexuspine, Inc. · Orthopedic device
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Oct 2005
Decision
170d
Days
Class 2
Risk

K050997 is an FDA 510(k) clearance for the EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Flexuspine, Inc. (Tyler, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 170 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Flexuspine, Inc. devices

FDA 510(k) Submission Details - K050997

510(k) Number K050997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2005
Decision Date October 07, 2005
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 218
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K050997.
STRYKER SPINE AVS ASL PEEK SPACER
K051205 · Stryker Spine · Nov 2005
KIMBA SPINAL IMPLANT
K052533 · Signus Medizintechnik GmbH · Nov 2005
CONCORDE VBR SPINAL SYSTEM
K052746 · Depuy Spine, Inc. · Oct 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · Implex Corp. · Sep 2005
SEMIAL SPINAL IMPLANT
K051659 · Signus Medizintechnik GmbH · Jul 2005