SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT

K130302 · Spinevision S.A. · MNI · Jul 30, 2013 · Orthopedic

Device Facts

• Record ID: K130302
• Device Name: SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
• Applicant: Spinevision S.A.
• Product Code: MNI · Orthopedic
• Decision Date: Jul 30, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the U.L.I.S. ™ and LUMIS™ systems are indicated for: · degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - · spondylolisthesis - fracture - · spinal stenosis - · tumors - · failed previous fusion (pseudoarthrosis) The U.L.I.S. ™ and LUMIS™ systems are pedicie screw systems indicated for skeletally mature patients who: - · have severe spondvlolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - · receive fusions using autogenous bone graft only; - have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and - · have the device removed after the development of a solid fusion. In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1): • degenerative spondylolisthesis with objective evidence of neurologic impairment - fracture - spinal tumor - · failed previous fusion (pseudoarthrosis)

Device Story

SpineVision LUMIS and U.L.I.S. systems are pedicle screw fixation systems consisting of cannulated/non-cannulated screws and rods. Used by surgeons in spinal fusion procedures to provide rigid immobilization and stabilization of spinal segments. Components are assembled into constructs tailored to patient anatomy using specialized manual instruments. The device is implanted during surgery to support the spine during the development of solid bone fusion. Once fusion is achieved, the device may be removed. Benefits include correction of spinal deformities and stabilization of unstable segments in the thoracic, lumbar, and sacral spine.

Clinical Evidence

No clinical data presented. Bench testing only.

Technological Characteristics

Pedicle screw spinal system. Materials: Titanium Ti-6Al-4V ELI (ASTM F136/ISO 5832-3). Components: Cannulated and non-cannulated polyaxial screws, fixation rods, and manual surgical instruments. Non-sterile supply. Mechanical stabilization principle.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for degenerative disc disease, spondylolisthesis (including severe L5-S1 grades 3-4), fractures, spinal stenosis, tumors, or pseudoarthrosis in the thoracic, lumbar, and sacral spine (T10-S1). Requires autogenous bone graft.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• SpineVision LUMIS™ Cannulated Polyaxial Pedicle Screw Fixation System and SpineVision U.L.I.S.™ Polyaxial Pedicle Screw Fixation System (K112607)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUL 3 0 2013

| Submitter | SpineVision, S.A.<br>Antony parc II<br>10 place du Général de gaulle<br>CS70001<br>Antony Cedex 92184, France<br>Tel: [phone]<br>Fax: + 33 1 53 33 25 39 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Helene PLAS, QA&RA Manager<br>Tel: [phone]<br>Fax: + 33 1 53 33 25 39<br>[e-mail] |
| Date | June 13, 2013 |
| Trade Name | SpineVision LUMIS™ Cannulated Polyaxial Pedicle Screw<br>Fixation System<br>SpineVision U.L.I.S.™ Polyaxial Pedicle Screw Fixation<br>System |
| Common Name<br>Classification Name | Pedicle Screw Spinal System |
| Product code | MNI, MNH, KWQ, KWP |
| CFR section | 888.3070 |
| Legally marketed<br>predicate device | SpineVision LUMIS™ Cannulated Polyaxial Pedicle Screw<br>Fixation System and SpineVision U.L.I.S.™ Polyaxial Pedicle<br>Screw Fixation System - K112607 manufactured by<br>SPINEVISION S.A. |
| SPECIAL 510k | Modification to K112607 (Extension of range of products) |

# 510(k) SUMMARY

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ Description System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) instrumentations are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods (SpineVision UNI-Thread™ rods or LUMIS™ percutaneous rods). Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied nonsterile.

> These constructs are assembled using specific instruments. The components of the U.L.I.S.™ and LUMIS™ systems are made of Titanium Ti-6Al-4V ELI complying with ASTM F136 (ISO 5832-3).

The components added within this submission include:

- New reference of LUMIS™ rods (Straight and pre-bent)

- 12 new instruments for LUMIS™ system (MS1-A214 Enlarged screw extender, MS1-A274 Rod Introducer, MS1-A275 Reversed rod introducer, MS1-A276 Rotating rod introducer,

{1}------------------------------------------------

MS1-A235 T10 screwdriver for rod introducer, MS1-A331 Compressor-Distractor, MS1-A332 Extender plug for distractor-Screw fixation for distractor-MS1-A333 compressor, compressor, MS1-A334 Fulcrum connector for distractorcompressor, MS1-A335 Multiple connector for distractorcompressor, MS1-A112 Expander 2, MS1-A113: Expander 3) - 4 new instruments for U.L.I.S.™ system (IS1-A312 Rocker, IS1-A222 Sleeve for screwdriver, IS1-A225 Sleeve for U.L.I.S.TM screw Ø5,5 mm, IS1-A226 Sleeve for U.L.I.S.TM screw Ø6,5 mm – Ø7,5 mm).

When used for anterior screw fixation or as a posterior, non-Intended use pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMIS™ systems are indicated for:

> · Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

- · Spondylolisthesis
- Fracture
- Spinal stenosis
- Tumors
- · failed previous fusion (pseudoarthrosis)

The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who:

· have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;

· receive fusions using autogenous bone graft only;

· have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and

· have the device removed after the development of a solid fusion.

In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1):

· Degenerative spondylolisthesis with objective evidence of neurologic impairment

- · Fracture
- · Spinal tumor
- · failed previous fusion (pseudoarthrosis)

Summary of Technological Characteristics The SpineVision Universal Lumbar Intuitive System (U.L.I.S. ™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) instrumentations are manufactured in made in Titanium Ti-6Al-4V ELI complying with ASTM F136. The LUMIS™ Pedicle screw system is Page 2 / 3

{2}------------------------------------------------

The devices provide correction and rigid cannulated. stabilization of the spine during development of solid bone fusion following corrective spine surgery for a number of indications (listed above).

Universal Lumbar Intuitive System Performance data The SpineVision® (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) conform to special control established for Pedicle Screw Spinal System and to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004.

> No additional testing has been performed for the added components.

No clinical data has been presented.

SpineVision Universal Lumbar Intuitive System (U.L.I.S.™ Substantial equivalence System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are substantially equivalent to their predicate devices Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) in terms of intended use, indications for use, material, design, mechanical properties and function.

Engineering analysis and design validation/verification were Conclusion used to support substantial equivalence. SpineVision Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are as safe, as effective, and performs as safety and effectively as their predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular seal containing the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

SpineVision S.A. % Ms. Helene Plas Quality Affairs & Regulatory Affairs Manager Antony Parc II, 10 Place du Général de Gaulle CS 70001. Antony Cedex, 92184 FRANCE

Rc: K130302

Trade/Device Name: Spine Vision LUMIS™ Cannulated and U.L.I.S. TM Polyaxial Pedicle Screw Fixation Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI. MNH. KWQ. KWP Dated: June 13, 2013 Received: July 1, 2013

July 30, 2013

Dear Ms. Plas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{4}------------------------------------------------

#### Page 2 - Ms. Helene Plas

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

### Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### INDICATIONS FOR USE

510(k) Number: K130302

Device Name:

SpineVision LUMIS™ Cannulated Polyaxial Pedicle Screw Fixation System

### SpineVision U.L.I.S.™ Polyaxial Pedicle Screw Fixation System

Indications for Use:

When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the U.L.I.S. ™ and LUMIS™ systems are indicated for:

· degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

- · spondylolisthesis
- fracture
- · spinal stenosis
- · tumors
- · failed previous fusion (pseudoarthrosis)

The U.L.I.S. ™ and LUMIS™ systems are pedicie screw systems indicated for skeletally mature patients who:

- · have severe spondvlolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- · receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- · have the device removed after the development of a solid fusion.

In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1):

• degenerative spondylolisthesis with objective evidence of neurologic

- impairment
- fracture
- spinal tumor
- · failed previous fusion (pseudoarthrosis)

Prescription Use | | (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130302