The Preference Pedicle Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Preference Pedicle Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis) and/or spinal deformities such as scoliosis, kyphosis or excessive lordosis.

In addition, when used as a pedicle screw fixation system, the Preference Pedicle Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Preference Pedicle Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Device Description

The Preference Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, hooks, connectors and rods. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-Eli) or Cobalt Chrome.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study that demonstrates the device meets these criteria.

The document is a 510(k) summary for the "Preference Pedicle Screw System," indicating it's a submission to the FDA for market clearance. It details:

Contact Information: Trace Cawley, US Spinal Technologies.
Trade Name: Preference Pedicle Screw System.
Classification: Pedicle screw spinal system (21 CFR §888.3070), Spinal intervertebral body fixation orthosis (§888.3060), Spinal interlaminal fixation orthosis (§888.3050).
Class: II.
Product Codes: KWO, KWP, MNH, MNI.
Indications for Use: Detailed descriptions for both pedicle screw fixation and posterior, non-cervical, non-pedicle screw fixation systems in the lumbar and/or sacral spine.
Device Description: Comprised of monoaxial and polyaxial pedicle screws, hooks, connectors, and rods, manufactured from medical grade titanium alloy or Cobalt Chrome.
Predicate Device(s): US Spinal Technologies Preference Pedicle Screw System (K081296), DePuy Expedium Spine System (K073364, K041119 and K033901), and Stryker Xia Spinal System (K080928 and K060361).
Substantial Equivalence: The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

Missing Information:

The document focuses on establishing substantial equivalence to previously cleared devices based on similar indications for use, design, function, and materials. It does not describe a study involving specific acceptance criteria and performance metrics in the way requested for medical device software or AI systems.

Therefore, I cannot provide the requested table or answer any of the questions (1-9) regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text. This device is a physical implant, and its clearance relies on established equivalence to existing devices, not typically on performance metrics derived from clinical studies with ground truth in the same way an AI diagnostic tool would.

Summary

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4. 510(k) Summary according to 807.92(c)

Contact:	Trace CawleyUS Spinal Technologies3600 FAU Blvd., Suite 101Boca Raton, FL 33431561-367-7463
Trade Name:	Preference Pedicle Screw System
Classification:	21 CFR §888.3070 Pedicle screw spinal system§888.3060 Spinal intervertebral body fixationorthosis§888.3050 Spinal interlaminal fixation orthosis
Class:	II
Product Codes:	KWO, KWP, MNH, MNI

Indications for Use:

Page 1 of 2

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Device Description:

Predicate Device(s):

The Preference Pedicle Screw System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These devices include the US Spinal Technologies Preference Pedicle Screw System (K081296), DePuy Expedium Spine System (K073364, K041119 and K033901) and the Stryker Xia Spinal System (K080928 and K060361).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus, a symbol associated with medicine and healthcare.

Public Health Service

SEP 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

US Spine % Silver Pine Consulting Mr. Richard Jansen 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K081883

Tradc/Device Name: Preference Pedicle Fixation System Regulation Number: 21 CFR 888.3070 Regulation Namc: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI, KWP, KWP, KWO Dated: July 01, 2008 Received: July 07, 2008

Dear Mr. Jansen:

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. Richard Jansen

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark H. Miller

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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3. Indications for Use

510(k) Number (if known): _ K o8 188 3

Indications for Use:

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

510(k) Number	K081883
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6/27/2008

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.