LOWTOP PEDICLE SCREW SYSTEM by SANACOR

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.

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

Device Description

The LowTop Pedicle Screw System is a spinal system that consists of screws, rods, connectors and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using a posterior approach.

AI/ML Overview

The LowTop Pedicle Screw System is a spinal implant system. The provided text describes the device's mechanical testing, which served as the study to demonstrate it met the acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria (Standard)	Reported Device Performance
Static Compression Bending	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"
Static Torsion	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"
Dynamic Compression Bending	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"

Sample Size and Data Provenance:
- The document does not specify the exact sample sizes used for each mechanical test.
- The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. This was a laboratory study of a medical device, not a clinical trial with patient data.
Number of Experts and their Qualifications (for ground truth):
- Not applicable. This device is hardware that underwent mechanical testing against engineering standards, not an AI or diagnostic device that requires expert-established ground truth from clinical data.
Adjudication Method (for ground truth):
- Not applicable, as this was a mechanical testing study against established engineering standards rather than a clinical study requiring consensus among experts.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This is a mechanical device, and such studies are typically for AI-powered diagnostic or interpretive tools.
Standalone Performance Study:
- Yes, the "standalone" performance in this context refers to the device's mechanical integrity as an independent unit. The mechanical testing itself, conducted on the device, represents its standalone performance.
Type of Ground Truth Used:
- The "ground truth" for this device's performance was the specifications and requirements outlined in the ASTM F1717 standard for spinal implant constructs.
Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an algorithm that requires a training set.
How the Ground Truth for the Training Set was Established:
- Not applicable. There was no training set for this type of device.

Summary

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K070933

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510(k) Summary

and the comments of the

Submitter:	Sanacor LLCJUN 1 3 2007
Contact Person:	Mr. David Hawkes, PresidentSanacor LLC765 E 340 S Suite 204American Fork, UT 84003Telephone: (801) 756-8255Fax: (801) 756-8286
Date Prepared:	March 27, 2007
Trade Name:	LowTop Pedicle Screw System
Classification, Nameand Number:	Class IIPedicle Screw System21 CFR 888.3070
Product Code:	MNI and MNH
Predicate Device(s):	The subject device is substantially equivalent to the followingdevices:
	ConKlusion Pedicle Screw System (K031455)Marketed and distributed by Signus Medical LLC
	Optima Pedicle Screw System (K020279)Marketed and distributed by Zimmer Spine
	OvalTwist Pedicle Screw System (K061577)Marketed and distributed by Signus Medical LLC
Device Description:	The LowTop Pedicle Screw System is a spinal system that consistsof screws, rods, connectors and associated instruments. Fixation isprovided by bone (pedicular) screws inserted into the vertebralbody of the spine using a posterior approach.
Intended Use:	The LowTop Pedicle Screw System is intended to provideimmobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion in the treatment of thefollowing acute instabilities or deformities of the thoracic, lumbar,and sacral spine: degenerative spondylolisthesis with objectiveevidence of neurological impairment, fracture, dislocation,scoliosis, kyphosis, spinal tumor, and failed previous fusion(Pseudoarthrosis).

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K070933

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
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.
(b)
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.