Cleared Traditional

K041617 - STALIF TT

K041617 is the FDA 510(k) clearance for STALIF TT by Surgicraft , Ltd.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K041617 · Surgicraft , Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2004
Decision
85d
Days
Class 2
Risk

K041617 is an FDA 510(k) clearance for the STALIF TT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Surgicraft , Ltd. (Chicago, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 85 days - a notably fast clearance 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: 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 Surgicraft , Ltd. devices

Submission Details

510(k) Number K041617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date September 08, 2004
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 153
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K041617.
EBI CAS SPINE SPACER SYSTEM
K042268 · Ebi, L.P. · Oct 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389 · Synthes Spine · Oct 2004
MODIFICATION TO VBR SPINAL SYSTEM
K041722 · Depuy Spine, Inc. · Sep 2004
EXPANDABLE PEEK VBR IMPLANT
K040928 · Interpore Cross Intl. · Aug 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
K041939 · Blackstone Medical, Inc. · Aug 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041197 · Medtronic Sofamor Danek · Aug 2004