LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

K100575 · Ldr Spine USA · MNI · Mar 31, 2010 · Orthopedic

Device Facts

• Record ID: K100575
• Device Name: LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
• Applicant: Ldr Spine USA
• Product Code: MNI · Orthopedic
• Decision Date: Mar 31, 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 posterior, top-loading spinal fixation system. Components include pedicle screws, rods, set screws, transverse connectors, and lateral, axial, and domino connectors. Used by surgeons in clinical settings to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments. Device acts as an adjunct to fusion using autogenous bone graft. System provides mechanical support to treat acute and chronic spinal instabilities or deformities. Benefits include stabilization of spinal segments to facilitate fusion and address conditions like trauma, stenosis, and deformity.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Posterior, top-loading spinal fixation system. Components: pedicle screws, rods, set screws, transverse connectors, lateral/axial/domino connectors. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for skeletally-mature patients requiring immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. 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

• Perfix Spinal System (K091725)

Submission Summary (Full Text)

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

# 510(k) Summary LDR Spine SpineTune™ TL Spinal System

MAR 3 1 2010

# 1. Owner's Name & Address

LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: [phone] Fax: [phone]

#### 2. Contact Person

# Noah Bartsch, MS, RAC

Manager, Clinical, Requlatory & Quality Affairs LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

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

- 3. Date 510(k) Summary Prepared: February 26, 2010
- 4. Trade Name: LDR Spine SpineTune™ TL Spinal System Common Name: Spinal Fixation System (MNH, MNI, KWP) Classification: MNH 888.3070 - Orthosis, Spondilolisthesis SpinalFixation MNI 888.3070 - Orthosis, Spinal Pedicle Fixation KWP 888.3050 - Orthosis, Spinal Interlaminal Fixation
- 5. Legally Marketed Equivalent Predicate Device: Perfix Spinal System (K091725)

# 6. Device Description

The Spinetune TL Spinal System is a top-loading posterior spinal fixation system consisting of pedicle screws, rods, set screws, transverse connectors and lateral, axial and domino type connectors.

# 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

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

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

Non Clinical testing was not required.

The outcomes of verification and validation activities indicate that the propose SpineTune™ TL Spinal System is substantially equivalent to the predicate device.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling the image of an abstract caduceus. The caduceus is a symbol often associated with healthcare and medicine. The text is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 3 1 2010

LDR Spine USA % Mr. Noah Bartsch, MS, RAC Manager, Clinical, Regulatory and Quality Affairs 4030 West Braker Lane, Suite 360 Austin, Texas 78759

Re: K100575

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: February 26, 2010 Received: March 01, 2010

Dear Mr. Bartsch:

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.

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

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

Page 2 - Mr. Noah Bartsch, MS, RAC

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Barbere Boucher

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

Enclosure

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

# INDICATIONS FOR USE

510(k) Number (if known):

LDR Spine SpineTune™ TL Spinal System Device Name:

#### 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)

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

KI00575 510(k) Number_

4