Cleared Special

K031757 - PEEK TETRIS SPINAL IMPLANT

K031757 is an FDA 510(k) clearance for PEEK TETRIS SPINAL IMPLANT, manufactured by Signus Medical, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 54-day FDA review.

K031757 · Signus Medical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
54d
Days
Class 2
Risk

K031757 is an FDA 510(k) clearance for the PEEK TETRIS SPINAL IMPLANT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Signus Medical, LLC (Minneapolis, US). The FDA issued a Cleared decision on July 30, 2003 after a review of 54 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. 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.

FDA 510(k) Submission Details - K031757

510(k) Number K031757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2003
Decision Date July 30, 2003
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K031757.
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527 · Implex Corp. · Oct 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700 · Blackstone Medical, Inc. · Oct 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · Spinal Concepts, Inc. · Aug 2003
VERTE-STACK SPINAL SYSTEM
K031780 · Medtronic Sofamor Danek · Jul 2003
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
K031914 · Spinal Concepts, Inc. · Jul 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K031823 · Implex Corp. · Jul 2003
K031757 · PEEK TETRIS SPINAL IMPLANT
Download PDF FDA Summary Signus Medical, LLC