LOWTOP PEDICLE SCREW SYSTEM

K070933 · Sanacor · MNH · Jun 13, 2007 · Orthopedic

Device Facts

• Record ID: K070933
• Device Name: LOWTOP PEDICLE SCREW SYSTEM
• Applicant: Sanacor
• Product Code: MNH · Orthopedic
• Decision Date: Jun 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LowTop Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) with removal of the implants after the attainment of a solid fusion.

Device Story

LowTop Pedicle Screw System is a spinal fixation device consisting of screws, rods, and connectors. Used by surgeons via posterior approach to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments. Acts as an adjunct to fusion. Benefits patients by stabilizing spinal segments in cases of acute instability or deformity. System components are implanted into the vertebral body to facilitate fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F1717, including static compression bending, static torsion, and dynamic compression bending. Results demonstrated the device performed as designed and met or exceeded all product specifications.

Technological Characteristics

Pedicle screw spinal system consisting of screws, rods, and connectors. Mechanical testing conducted per ASTM F1717. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring posterior, non-cervical pedicle fixation for spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion. Also indicated for severe spondylolisthesis (Grade 3-4) of L5-S1 with autogenous bone graft fusion (L3-S1).

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

• ConKlusion Pedicle Screw System (K031455)
• Optima Pedicle Screw System (K020279)
• OvalTwist Pedicle Screw System (K061577)

Submission Summary (Full Text)

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K070933

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## 510(k) Summary

:

and the comments of the

| Submitter: | Sanacor LLC<br>JUN 1 3 2007 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. David Hawkes, President<br>Sanacor LLC<br>765 E 340 S Suite 204<br>American Fork, UT 84003<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | March 27, 2007 |
| Trade Name: | LowTop Pedicle Screw System |
| Classification, Name<br>and Number: | Class II<br>Pedicle Screw System<br>21 CFR 888.3070 |
| Product Code: | MNI and MNH |
| Predicate Device(s): | The subject device is substantially equivalent to the following<br>devices: |
| | ConKlusion Pedicle Screw System (K031455)<br>Marketed and distributed by Signus Medical LLC |
| | Optima Pedicle Screw System (K020279)<br>Marketed and distributed by Zimmer Spine |
| | OvalTwist Pedicle Screw System (K061577)<br>Marketed and distributed by Signus Medical LLC |
| Device Description: | The LowTop Pedicle Screw System is a spinal system that consists<br>of screws, rods, connectors and associated instruments. Fixation is<br>provided by bone (pedicular) screws inserted into the vertebral<br>body of the spine using a posterior approach. |
| Intended Use: | The LowTop Pedicle Screw System is intended to provide<br>immobilization and stabilization of spinal segments in skeletally<br>mature patients as an adjunct to fusion in the treatment of the<br>following acute instabilities or deformities of the thoracic, lumbar,<br>and sacral spine: degenerative spondylolisthesis with objective<br>evidence of neurological impairment, fracture, dislocation,<br>scoliosis, kyphosis, spinal tumor, and failed previous fusion<br>(Pseudoarthrosis). |

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K070933

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In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) with removal of the implants after the attainment of a solid fusion.

Mechanical testing of the subject device consisted of static compression bending, static torsion and dynamic compression bending. All testing was conducted in accordance with ASTM F1717. The device performed as designed and met, or exceeded, all product specifications.

Sanacor LLC considers the LowTop Pedicle Screw System to be equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in functional design

Safety Testing:

Functional and

Conclusion:

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sanacor LLC c/o Mr. Michael Ensign Director of Engineering 765 East 340 South, Suite 204 American Fork, Utah 84003

JUN 1 3 2007

Re: K070933

Trade/Device Name: LowTop Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: March 30, 2007 Received: April 6, 2007

Dear Mr. Ensign:

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 such 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); 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 - Mr. Michael Ensign

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jarbare Buelm

Mark N. Melkerson 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): __ NA- K 070933

Device Name: LowTop Pedicle Screw System

Indications for Use:

The LowTop System is intended for posterior, non-cervical pedicle fixation for the following indications:

· Spondylolisthesis

· Trauma (i.e., fracture or dislocation)

· Spinal stenosis

· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

• Tumor

• Pseudoarthrosis

· Failed previous fusion

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) 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)

Olubare Buens

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

**510(k) Number** K070933