RANGE SPINAL SYSTEM, LARGE DENALI SCREWS

K081381 · K2m, Inc. · MNH · Jun 13, 2008 · Orthopedic

Device Facts

• Record ID: K081381
• Device Name: RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
• Applicant: K2m, Inc.
• Product Code: MNH · Orthopedic
• Decision Date: Jun 13, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Range Spinal System is a: Non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications; degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Mesa Spinal System is also intended for: Non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

Device Story

Range Spinal System is a top-loading, posterior spinal fixation system; components include pedicle screws, rods, hooks, and transverse connectors. Used by surgeons in clinical settings to provide immobilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Components are available in various sizes to match patient anatomy. System provides structural stabilization to the spine; helps facilitate bone fusion; potentially reduces pain and restores spinal alignment in patients with degenerative or traumatic conditions.

Clinical Evidence

Bench testing only. Biomechanical testing performed per ASTM F1717 compared the device to predicate systems; results showed performance equal to or better than predicates.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: Ti6Al-4V ELI alloy per ASTM and ISO standards. Components: pedicle screws, rods, hooks, transverse connectors. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for non-cervical spinal fixation in patients with degenerative disc disease, spondylolisthesis (including severe grades 3-4 at L5-S1 in skeletally mature patients), trauma (fracture/dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion. Requires autogenous bone graft for severe spondylolisthesis.

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

• Range Spinal System (K2M, Inc.)
• Expedium (DcPuy)

Submission Summary (Full Text)

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#### 510(k) Summary for the Range Spinal System,

This safety and effectiveness summary for the Mesa Spinal per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

1. Submitter : K2M, Inc. 751 Miller Drive SE, Suite F1

Leesburg, VA 20175

Date Prepared: May 07, 2008 Contact Person : Richard W. Woods K2M, LLC 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: [phone]

| 2. Tradename: | Range Spinal System |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Common Name: | Spine Fixation System |
| Classification Name: | Pedicle Screw Spinal System (21 CFR 888.3070(b)(1))<br>Spinal Interlaminal fixation orthosis (21 CFR 888.3050) |

#### 3. Predicate or legally marketed devices which are substantially equivalent :

- . Range Spinal System ( K2M, Inc.)
- . Expedium (DcPuy)

#### 4. Description of the device :

The Range Spinal System is a top-loading, multiple component, posterior system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards,

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.

#### 5. Intended Use:

The Range Spinal System is a:

Non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications; degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Mesa Spinal System is also intended for:

Non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

#### 6. Comparison of the technological characteristics of the device to predicate and legally marketed

## devices :

The Range Spinal System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717. The design features and sizing of the components were also compared and the Range Spinal System found to be substantially the same as these systems. It is manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems. There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 19 2009

K2M, Inc. % Ms. Nancy Giezen 751 Miller Drive, Southeast, Suite F1 Leesburg, Virginia 20175

Re: K081381

Trade/Device Name: Range Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI, KWP Dated: May 16, 2008 Received: May 16, 2008

Dear Ms. Giezen:

This letter corrects our substantially equivalent letter of June 13, 2008.

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 (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 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.

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## Page 2- Ms. Nancy Giezen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Daniel Krane

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

Enclosure

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# KOQ138 |

## Indications for Use

## 510(k) Number: 300000000

Device Name: Range Spinal System

Indications for Use:

Non-cervical spinal fixation devices intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion.

Non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1,3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

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

Over-the-counter Use (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)

Neil R. Odlum

Division of General, Restorat and Neurological Devices

510(k) Number K081391

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