MESA SPINAL SYSTEM

K052398 · K2m, LLC · MNI · Dec 7, 2005 · Orthopedic

Device Facts

• Record ID: K052398
• Device Name: MESA SPINAL SYSTEM
• Applicant: K2m, LLC
• Product Code: MNI · Orthopedic
• Decision Date: Dec 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mesa 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 degencration 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 skelctally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the attainment of a solid fusion.

Device Story

Mesa Spinal System is top-loading, posterior spinal fixation system; components include pedicle screws, rods, hooks, transverse connectors. Used as adjunct to fusion to immobilize thoracic, lumbar, sacral spinal segments. Surgeon implants hardware to stabilize spine; provides structural support during bone healing. System components available in various sizes to match patient anatomy. Device used in surgical setting by orthopedic or neurosurgeons. Clinical benefit includes stabilization of spinal segments to facilitate fusion in patients with degenerative or traumatic spinal conditions.

Clinical Evidence

Bench testing only. Biomechanical testing performed per ASTM F1717 to compare performance against predicate systems.

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. Non-sterile (implied).

Indications for Use

Indicated for non-cervical spinal fixation in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or failed fusion. Includes pedicle screw fixation for severe L5-S1 spondylolisthesis (grades 3-4) in skeletally mature patients.

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

• Denali Spine System (K2M, LLC)
• Versalok Low Back Fixation System (Wright Medical)
• Ovation Polyaxial System (Osteotech)

Submission Summary (Full Text)

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DEC 7 2005

K052398

Page lot 1

510(k) Summary

## for the

### Mesa Spinal System

s safety and effectiveness summary for the Mesa Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

#### 1. Submitter :

K2M, LLC 751 Miller Drive SE, Suite Fi Leesburg, VA 20175

August 29, 2005 Date Prepared:

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

| 2. Tradename: | Mesa 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 :

- Denali Spine System ( K2M, LLC ) .
- Versalok Low Back Fixation System ( Wright Medica! ) .
- Ovation Polyaxial System ( Osteotech ) .

#### 4. Description of the device :

The Mesa Spine System is a top-loading, multiple component, posterior spinal fixation 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 Mesa 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 degencration 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 skelctally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the attainment of a solid fusion.

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

The Mesa Spine 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 Mesa 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 Mesa 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 7 2005

Mr. Richard W. Woods Senior Vice President K2M, LLC 751 Miller Drive, S.E., Suite Fl Leesburg, Virginia 20175

Re: K052398

Trade/Device Name: Mesa Spinal System TraderDon Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWP Dated: November 16, 2005 Received: November 17, 2005

Dear Mr. Woods:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IV(x) premaince is substantialy equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have determined the actives marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally manect prodical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug, commerce prior to May 28, 1976, the enactinent use of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval or a policions of the Act. The
You may, therefore, market the device, subject to the general contracts of listing of You may, therefore, market the device, subject to the general vonmul registration, listing of
general controls provisions of the Act include requirements for annual mishrandi general controls provisions of the Act mende requirements to the more of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into entitle tass in topedia ions affecting your device can
may be subject to such additional controls. Existing major regulations a may be subject to such additional controlist Listing introl organto 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Federal Regulations, Fride 24, 11, 2017, 11:15 Pederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substance of the requirements of the Act
that FDA has made a determination that your device complies with other requirements You that FDA has made a determination hia your devres on per Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listi or any Federal statutes and regulations and limited to registration and listing (21
comply with all the Act's requirements, including, but not mements as sct comply with all the Act s requrements, mendenting practice requirements as sch
CFR Part 807); labeling (21 CFR Part 801); good manafacturing practice requirements as sc CFR Part 807); labeling (21 CFR Part of ); good manakeraning philifapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicabl forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 -- Mr. Richard W. Woods

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the first of a first of a location to be mixelers of your device to This letter will anow you to begin marksmig your antial equivalence of your device to a legally
premarket notification. The FDA finding of sybstantial equivales and thus, pe premarket notification. The FDA multing of substantal equive and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac on on on on on on on on the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulatio contact the Office of Compliance at (211) 216 other (21 CFR Part 807.97). You may obtain
"Misbranding by reference to premarket not he the of first the Division of Small "Misbranding by relefence to premation international the Act from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 638 other general information on your responsionner Assistance at its toll-free number [phone] or Manufacturers, International and Consumer Assistance at to restoration of the industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson તેમ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K052398

Device Name: Mesa Spinal System

Indications for Use:

The Mesa 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; 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 'pondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by utogenous 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.

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)

signature

(Division Sigu-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_ K 052 39 8 __