The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:

Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with t degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis .
Spinal Stenosis .
Fracture/Dislocation .
Tumors .
Pseudoarthrosis .
Revision of previous cervical and upper thoracic spine surgery .

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine,

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

Device Description

The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient pathology. The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6A1-4V (ELI) per ASTM F136 and ISO 5832-3. To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer. The purpose of this submission is the addition of a head to head cross connector.

AI/ML Overview

This is a 510(k) summary for a medical device called the Atoll™ Cervico-Thoracic System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's clinical performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a table of acceptance criteria or reported device performance in the sense of clinical effectiveness or accuracy studies. This 510(k) submission is primarily focused on demonstrating substantial equivalence based on similarities in intended use, design, and physical characteristics to previously cleared predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The submission focuses on device characteristics, not clinical study data for a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. There is no mention of a "test set" or ground truth establishment by experts in the context of clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided for the reason mentioned above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is a spinal fixation system, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided and is not applicable as the device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided, as the submission does not detail a clinical study with "ground truth."

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not a machine learning device.

9. How the ground truth for the training set was established

This information is not provided for the reason mentioned above.

Summary of available information relevant to acceptance criteria (interpreted as basis for clearance):

The "acceptance criteria" in the context of this 510(k) submission are the demonstrations that the device is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria (for 510(k) clearance): The Atoll™ Cervico-Thoracic System must demonstrate substantial equivalence to predicate devices in terms of:
- Intended Use
- Design
- Physical Characteristics
- Material Composition
Study/Evidence that proves the device meets perceived "acceptance criteria":

The submission asserts that the "Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices."
- Intended Use: The provided "Indications for Use" for the Atoll™ Cervico-Thoracic System (C1-T3 fusion for various conditions like DDD, Spondylolisthesis, Spinal Stenosis, Fracture/Dislocation, Tumors, Pseudoarthrosis, Revision surgery) are implicitly considered substantially equivalent to the indications of the predicate devices.
- Design: The device is described as "consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes." The specific modification in this submission is "the addition of a head to head cross connector." The design is deemed similar to the predicates.
- Physical Characteristics: Not explicitly detailed in comparative tables, but implied by the device description and comparison to predicates.
- Material Composition: "Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3" which is a common and accepted material for such implants, likely matching or being equivalent to the predicate devices.
The study itself is the 510(k) submission process, where the sponsor provides documentation and justifications for these similarities to the FDA. The FDA's review and subsequent clearance (as indicated by the letter from MAR 13 2009) signify that the agency accepted the sponsor's demonstration of substantial equivalence. No specific clinical trial, as would be conducted for a novel device or one requiring PMA, is described or referenced.

Summary

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K083073

Image /page/0/Picture/1 description: The image shows a logo with the word "Theken" in a stylized font. The "T" is large and has a curved line above it. The rest of the letters are in a sans-serif font. There is a line underneath the word with some additional text, but it is difficult to read.

mar 1 3 2009

510(k) Summary (21 CFR Part 807.92)

A. Submitter Information

Submitter's Name:Establishment Registration #:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:	Theken Spine, LLC15309011800 Triplett Blvd.Akron, Ohio 44306330-475-8600330-773-7697Dale Davison10/15/08
Device InformationB.
Trade Name:	Atoll™ Cervico-Thoracic System
Common Name:	Posterior Cervical Instrumentation
Classification:	Class II System with the corresponding product codes:KWP 888.3050 - Spinal Interlaminal Fixation OrthosisMNI 888.3070(b) (1) - Pedicle Screw Spinal System
Predicate Devices:	Theken -- Atoll Cervico-Thoracic System (K070638, K080790)
Comparable Device:	DePuy Spine (USA) - Mountaineer OCT Spinal System (K080828)
Material Composition:	Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3
Subject Device Description:	The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. Itconsists of screws, hooks, rods, and connectors. These components are available in avariety of sizes to allow for a variety of configurations to better fit each individualpatient pathology.The Atoll Cervico-Thoracic System components are manufactured from medicalimplant grade titanium alloy Ti-6A1-4V (ELI) per ASTM F136 and ISO 5832-3.To achieve the best results, unless otherwise specifically described in anotherTheken Spine document, do not use Atoll Cervico-Thoracic System components inconjunction with components for any other system or manufacturer.The purpose of this submission is the addition of a head to head cross connector.

pg 1 of 2
F-2

Headquarters: 1800 Triplett Blvd. ‫(1800 Thine: 330.475.8600 · Fax: 330.73.7697 · www.thekenspine.com

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K083073

Image /page/1/Picture/1 description: The image shows a logo with the word "Theken" in a stylized font. The "T" is large and has a curved top, while the rest of the letters are in a sans-serif font. Below the word, there is a horizontal line with some text that is difficult to read due to the image quality.

Intended Use:

The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:

· Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Spondylolisthesis
· Spinal Stenosis
· Fracture/Dislocation
· Tumors
· Pseudoarthrosis
· Revision of previous cervical and upper thoracic spine surgery

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.

The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors

C. Substantial Equivalence

The characteristics of the Atoll Cervico-Thoracic System are similar to the following predicate devices:

1 . Atoll Cervico-Thoracic System (K070638, K080790) manufactured by Theken Spine.
1. Mountaineer OCT Spinal System (K042508) manufactured by DePuy Spine.

Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices. Therefore, Theken Spine believes that there is sufficient evidence to conclude that the Atoll Cervico-Thoracic System is substantially equivalent to existing legally marketed devices.

Headquarters: 1800 Triplett Blvd. a Akron, Ohio 44306 = Phone: 330.773.7697 = www.thekenspine.com

pg 2 of 2
F-3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized eagle emblem with three wing-like shapes.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Theken Spine, LLC % Mr. Dale Davison 1800 Triplett Boulevard Akron, Ohio 44306

MAR 1 3 2009

Re: K083073

Trade/Device Name: Atoll™ Cervico-Thoracic System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI. KWP Dated: February 20, 2009 Received: February 23, 2009

Dear Mr. Davison:

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. Dale Davison

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 the reporting 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,

Aloha

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):

Device Name: Atoll'in Cervico-Thoracic System

Indications For Use:

The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:

Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with t degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis .
Spinal Stenosis .
Fracture/Dislocation .
Tumors .
Pseudoarthrosis .
Revision of previous cervical and upper thoracic spine surgery .

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine,

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

Prescription Use X_ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

Page 1 of 1

E-2

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.