SPINAL EDGE TITAN PEDICLE SCREW SYSTEM

K091110 · Spinal Edge, LLC · MNH · Jul 24, 2009 · Orthopedic

Device Facts

• Record ID: K091110
• Device Name: SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
• Applicant: Spinal Edge, LLC
• Product Code: MNH · Orthopedic
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Device Story

TITAN Pedicle Screw System is a spinal fixation implant consisting of longitudinal rods, polyaxial screws, and transverse connectors. Used by surgeons in clinical settings to provide stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The system is implanted posteriorly in the noncervical spine (T8-S1) to treat conditions such as spondylolisthesis, trauma, stenosis, curvatures, tumor, pseudoarthrosis, and failed fusion. The device provides mechanical support to the spinal column to facilitate fusion.

Clinical Evidence

Bench testing only. Mechanical testing was performed in accordance with ASTM F1717 'Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model' using the longest pedicle screw (55mm) to evaluate bending stress.

Technological Characteristics

Constructed of titanium alloy conforming to ASTM F-136. System components include longitudinal rods, polyaxial screws, and transverse connectors. Mechanical testing conducted per ASTM F1717.

Indications for Use

Indicated for skeletally mature patients requiring posterior, noncervical pedicle fixation (T8-S1) for spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis/lordosis), tumor, pseudoarthrosis, or failed previous fusion. Used for stabilization and immobilization as an adjunct to bone graft fusion.

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

• DePuy 5.5 Moss Miami Ti (K030383)
• DePuy AcroMed MONARCH Spine System (K024348, K023438, K021335)

Submission Summary (Full Text)

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

K091110

#### 10.0 510(k) Summary

JUL 2 4 2009

- 1. Sponsor
Spinal Edge LLC 2275 Research Blvd. Suite 527 Rockville, MD 20805

| Primary Contact: | Ravi Sharma PhD |
|------------------|-----------------|
| Telephone: | 1- 866-915-9468 |

March 20, 2009 Date Prepared:

## 2. TITAN Pedicle Screw System:

| Proprietary Name: | TITAN Pedicle Screw System |
|----------------------|-----------------------------------------------------------------------------------|
| Common/Usual Name: | Pedicle Screw Spinal System |
| Classification Name: | Pedicle Screw Spinal System<br>(21 CFR 888.3070), Class II Product Codes MNH, MNI |

## 3. Predicate Devices

K030383 - DePuy 5.5 Moss Miami Ti K024348, K023438, K021335 - DePuy AcroMed MONARCH Spine System

## 4. Device Description

The Spinal Edge TITAN Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. The Spinal Edge TITAN Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.

## 5. Intended Use

The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

plotz

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

## 6. Technological Characteristics and Substantial Equivalent

The Spinal Edge TITAN Pedicle Screw System and its predicate device(s) have the same indications for use, operating principles and are made of the same materials.

Representative samples of the device underwent testing to demonstrate comparable function and performance characteristics to the predicate device.

### 7. Performance Testing

The testing method for the TITAN Pedicle Screw System was completed in accordance with ASTM F1717 "Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model". Part number SE-112-CA-5.75 55mm length screw was used for testing. The longest pedicle screw was tested to provide greatest potential for bending stress.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 4 2009

Spinal Edge LLC % Ms. Christina Vacca President 33650 Reserve Way Avon. Ohio 44011

Re: K091110

Trade/Device Name: Titan Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw system Regulatory Class: Class II Product Code: MNH, MNI Dated: June 30, 2009 Received: July 7, 2009

Dear Ms. Vacca:

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 enactment 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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Ms. Christina Vacca

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm.for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Barbara Bush

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

Enclosure

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

#### 9.0 Indications for Use Statement

510(k) Number (if Known): K091110

Indications for Use:

The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Prescription Use: _ X AND/OR Over-The-Counter Use: (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

E Z (EXT for MYM)

Jivision Sign-Off) Jivision of Surgical, Orthopedic, and Restorative Devices

Number K 09110