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Viper Spine System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071860

by Depuy Spine, Inc.

Identifiers

510(k) Number
K071860 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Viper Spine System is a spinal fixation device classified as a spinal fixation device under the FDA’s product code NKB. It is designed to provide immobilization and stabilization of spinal segments, facilitating surgical interventions for degenerative conditions, spinal deformities, and complex cases requiring fusion. Constructed from ASTM F-136 implant-grade titanium alloy, the system includes cannulated polyaxial screws and instrumentation tailored for minimally invasive procedures (MIS). Its modular design supports treatment of spinal stenosis, scoliosis, kyphosis, lordosis, tumors, pseudoarthrosis, and failed prior fusions in skeletally mature patients.

The Viper Spine System is supplied as a sterile, single-use surgical implant intended for orthopedic use under sterile conditions. It is approved for use in the United States via an FDA 510(k) clearance (K071860) under a Special Review classification, with a decision date of August 1, 2007. The system is not MRI-safe and requires proper handling, storage, and disposal in accordance with surgical protocols. Sizes and configurations are specified in the accompanying technical documentation, ensuring compatibility with minimally invasive surgical techniques.

Frequently asked questions

What types of spinal conditions is the Viper Spine System designed to address in patients?

The Viper Spine System is specifically designed to stabilize and immobilize spinal segments for surgical interventions in skeletally mature patients with degenerative conditions, spinal deformities, or complex cases requiring spinal fusion. This includes conditions like spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumors, pseudoarthrosis, and revisions of failed prior fusions. Its modular design and minimally invasive instrumentation are tailored to support these procedures.

Is the Viper Spine System intended for reuse, or is it meant to be used only once per patient?

The Viper Spine System is explicitly labeled as a sterile, single-use surgical implant. This means it is intended for one-time use in a single patient to maintain sterility and reduce infection risks, aligning with standard orthopedic surgical protocols.

What materials is the Viper Spine System made from, and why does this matter?

The system is constructed from ASTM F-136 implant-grade titanium alloy, a material chosen for its biocompatibility, strength, and corrosion resistance in the body. This ensures long-term stability and reduces the risk of adverse reactions during spinal fixation procedures.

How does the Viper Spine System accommodate minimally invasive surgery (MIS), and what does that mean for surgeons?

The Viper Spine System includes cannulated polyaxial screws and instrumentation specifically designed for minimally invasive procedures (MIS). This allows surgeons to perform spinal fixation through smaller incisions, reducing tissue trauma, lowering postoperative pain, and accelerating recovery compared to traditional open surgeries.

What storage and handling precautions should be taken with the Viper Spine System before use?

Since the Viper Spine System is sterile and single-use, it must be stored in its original packaging until ready for use to preserve sterility. Proper handling includes avoiding contamination, adhering to surgical protocols for unpacking, and following disposal guidelines to prevent cross-contamination. The system is not MRI-safe, so additional precautions are required if patients may undergo MRI scans post-surgery.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VIPER 2 MIS Spine System | Products | DePuy Synthes, PDF JJUN 2 3 2006K Modification to VIPERTM MIS System, VIPER SPINE SYSTEM by DEPUY SPINE, INC. | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Depuy Spine, Inc.

Sources (1)

  • FDA 510(k) K071860 24 fields · synced Sep 20, 2026