LDR SPINE USA SPINETUNE TL SPINAL SYSTEM

K102331 · Ldr Spine USA · MNI · Oct 15, 2010 · Orthopedic

Device Facts

• Record ID: K102331
• Device Name: LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
• Applicant: Ldr Spine USA
• Product Code: MNI · Orthopedic
• Decision Date: Oct 15, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpineTune™ TL Spinal System is a posterior, noncervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: Spondylolisthesis (Grade 3 and 4) . Degenerative spondylolisthesis with objective evidence of neurological . impairment Trauma (i.e., fracture or dislocation) . Spinal stenosis . Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) . . Tumor . Pseudoarthrosis Failed previous fusion .

Device Story

SpineTune™ TL Spinal System is a top-loading posterior spinal fixation system; consists of cannulated polyaxial pedicle screws, straight rods, curved rods, connectors, and set screws. Used by surgeons in clinical settings to provide spinal immobilization and stabilization. Device components are implanted to facilitate fusion via autogenous bone graft. System is an expansion of previously cleared SpineTune™ TL Spinal System (K100575) to include cannulated screw designs and additional rod sizes. Provides mechanical support to spinal segments; aids in correction of deformities and stabilization of instabilities.

Clinical Evidence

Bench testing only. Static compression bending, static torsion, and axial compression fatigue testing performed according to ASTM 1717 standards to validate the mechanical integrity of the cannulated polyaxial screw addition.

Technological Characteristics

Top-loading posterior spinal fixation system. Components: cannulated polyaxial pedicle screws, straight/curved rods, connectors, set screws. Mechanical testing performed per ASTM 1717. No software or electronic components.

Indications for Use

Indicated for skeletally-mature patients requiring immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion by autogenous bone graft. Conditions include Grade 3/4 spondylolisthesis, degenerative spondylolisthesis with neurological impairment, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous 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

• SpineTune™ Spinal System (K100575)
• OPTIMA™ Spinal System (K024096)

Submission Summary (Full Text)

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102.331

### 510(k) Summary

OCT 1 5 2010

LDR Spine SpineTune™ TL Spinal System Addition of Cannulated Pedicle Screws and Additional Size Rods

#### 1. Owner's Name & Address

#### LDR Spine USA

4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: [phone] Fax: [phone]

#### 2. Contact Person

#### Beckinam Nowatzke, MSRS

Quality Engineering and Regulatory Affairs Project Manager LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

[phone] Phone: [phone] Fax: [e-mail] Email:

- 3. Date 510(k) Summary Prepared: September 16, 2010
- LDR Spine SpineTune™ Spinal System 4. Trade Name: Spinal Fixation System (MNH, MNI, KWP) Common Name: MNH 888.3070 - Orthosis, Spondilolisthesis Spinal Fixation Classification: MNI 888.3070 - Orthosis, Spinal Pedicle Fixation KWP 888.3050 - Orthosis, Spinal Interlaminal Fixation

# 5. Legally Marketed Equivalent Predicate Device: SpineTune™ Spinal System (K100575)

OPTIMA™ Spinal System (K024096)

#### 6. Device Description

The SpineTune™ TL Spinal System is a top-loading multiple fixation system which consists of pedicle screws, straight rods, curved cods, connectors and set which of polyaxial pedicle screw design and additional sizes of the straight and curved rods are an addition to the previously cleared SpineTune™ TL Spinal System (K100575).

LDR Spine USA

Phone : [phone]
Fax: [phone]

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## 7. Intended Use of the Device

The SpineTune™ TL Spinal System is a posterior, noncervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

- Spondylolisthesis (Grade 3 and 4) .
- Degenerative spondylolisthesis with objective evidence of neurological . impairment
- Trauma (i.e., fracture or dislocation) .
- Spinal stenosis .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- . Tumor
- . Pseudoarthrosis
- Failed previous fusion .

### 8. Non-Clinical Performance Data

The outcomes of non-clinical testing performed (static compression bending, static torsion, and axial compression fatigue testing) according to ASTM 1717 indicate that the cannulated polyaxial screw addition to the SpineTune™ Spinal System is substantially equivalent to the predicate device.

4030 W. Braker Lane, Suite 360 Austin, Texas 78759

LDR Spine USA

page 2 of 2

Phone : [phone] Fax: [phone]

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

LDR Spine USA % Beckinam Nowatzke, MSRS Quality Engineering and Regulatory Affairs Project Manager 4030 West Braker Lane, Suite 360 Austin, Texas 78759

Re: K102331

Trade/Device Name: SpineTune" TL Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: September 17, 2010 Received: September 20, 2010

Dear Ms. Nowatzke:

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. Please note: CDRH does not evaluate information related to contract liability warranties. 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.

OCT 1 5 2010

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Page 2 - Beckinam Nowatzke, MSRS

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 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/ucm115809.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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours

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

Enclosure

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K102331

#### INDICATIONS FOR USE

OCT 1 5 2010

510(k) Number (if known):

Device Name:

LDR Spine USA SpineTune™ TL Spinal System

#### Indications for Use:

The SpineTune™ TL Spinal System is a posterior, noncervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

- · Spondylolisthesis (Grade 3 and 4)
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- · Pseudoarthrosis
- · Failed previous fusion

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richards/Shapiro

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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