The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following indications: degenerative disc discase (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, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are 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) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicte supplemental fixation device, Intended for use in the non-cervical spine (T1 – S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor.

The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spinc in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (1.5-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 pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: ( ) are receiving fusion with autogenous graft only, (2) who are having the device attached is the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

Device Description

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with cach construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY® rods and screws: DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The purpose of this 510(k) submission is to include modified CD HORIZON® set screws to the CD HORIZON® Spinal System.

AI/ML Overview

The provided text is a 510(k) summary for the CD HORIZON® Spinal System and its components. It describes an orthopedic device intended for spinal fixation and fusion, not an AI/ML-based medical device. Therefore, the information requested about acceptance criteria, study details, expert involvement, and performance metrics for an AI/ML device is not applicable to this document.

The document focuses on demonstrating substantial equivalence to previously cleared devices. This is a regulatory pathway for devices that are similar in intended use and technological characteristics to devices already on the market.

Here's how the provided information relates to substantial equivalence, rather than detailed performance criteria for an AI device:

Acceptance Criteria & Device Performance: The "acceptance criteria" for a 510(k) for a device like this are primarily demonstrating that the modified components (set screws in this case) do not raise new questions of safety and effectiveness compared to the predicate device. The "performance" is implicitly deemed acceptable if substantial equivalence is established. No specific quantitative performance metrics are provided in the document.
Study That Proves the Device Meets Acceptance Criteria: The study mentioned is a "Documentation, including a risk analysis," which was "provided which demonstrated the subject set screws to be substantially equivalent to predicate CD HORIZON® Spinal System set screws previously cleared in K052187 (SE 08/22/05) and K042025 (SE 08/25/04)." This is not a study in the context of an AI/ML device evaluating metrics like sensitivity or specificity.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Training Set, Ground Truth: These concepts are relevant to the development and validation of AI/ML algorithms, not typically for demonstrating substantial equivalence of a mechanical spinal implant system described here. The 510(k) process for such devices relies on comparing materials, design, indications for use, and performance data (often mechanical testing, biocompatibility, sterilization, etc. - though not detailed in this summary) to a predicate device.

In summary, because this document describes a mechanical spinal implant and not an AI/ML device, the specific questions regarding AI/ML device performance and study methodology are not applicable.

Summary

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2006 JAN 6

CD HORIZON® Spinal System Summary of Safety and Effectiveness December 2005

Medtronic Sofamor Danek, Inc. USA l. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Richard W. Treharne, PhD Contact: Senior Vice President Regulatory Affairs

Proposed Proprietary Trade Name: CD HORIZON® Spinal System II.
Classification Name(s)/Product Code(s): Spinal Interlaminal Fixation and Spinal III. Intervertebral Fixation Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3050, 888.3060 and/or 888.3070) Product Codes: MNI, MNH, KWP, KWQ, NQP and NKB

IV. Product Description

The purpose of this 510(k) submission is to include modified CD HORIZON® set screws to the CD HORIZON® Spinal System.

000022

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3474

V. Indications

The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc discase (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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following indications: degenerative disc disease (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, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spinc (T1 -- S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - 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); and/or tumor.

The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are 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 pedicle screw system in skeletally mature patients. the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only, (2) who are having the device attached to the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to

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K653474

the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

Substantial Equivalence VI.

Documentation, including a risk analysis, was provided which demonstrated the subject set screws to be substantially equivalent to predicate CD HORIZON® Spinal System set screws previously clearcd in K052187 (SE 08/22/05) and K042025 (SE 08/25/04).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract shapes that resemble human profiles or birds in flight. The overall design is simple and conveys a sense of health, well-being, and service.

2006 JAN 6

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis. Tennessee 38132

Re: K053474

Trade/Device Name: CD Horizon Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, NQP, MNI, MNH, KWP, KWQ Dated: December 12, 2005 Received: December 13, 2005

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 ro(t) premained is substantially equivalent (for the indications referenced above and nave determined the arredicate devices marketed in interstate for use stated in the encrosule for tegally mancted provice Americal Device Americal Society of to commerce prior to May 28, 1970, the chaounters and of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the UMAN devices that have been reclassified in accessary val of a premarket approval applicians of the Act . The and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Act. The Act. The You may, therefore, market the device, basjoct to the most
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rice here and prohibitions against 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) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlis. Entonigations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peacharterganing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination areas not mean Picase be advised that FDA s issuated on a bevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a determination that your administered by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21 comply with an the Act s requirements, mortains.
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Dr. Treharne

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.

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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulkerson

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

Enclosure

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510(k) Number (if known): K653474

Device Name: CD HORIZON® Spinal System

Indications for Use:

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spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: ( ) are receiving fusion with autogenous graft only, (2) who are having the device attached is the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

Prescription Use X (Part 21 CFR 801 Subpart D)

...

Over-Th

Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K053474 p.2/2

page 2 of 2

Regulation Number and Section

N/A