When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks

The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

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.

Multi-axial Screws

The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Connectors

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

Device Description

The VERTEX® Reconstruction System is a posterior svstem, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.

The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi), Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.

To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopaedic and neurosuraical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

AI/ML Overview

The provided document describes a 510(k) summary for the VERTEX® Reconstruction System, which is a spinal interlaminal fixation orthosis. The purpose of this 510(k) is to add additional components to the existing system. The document does not describe a study involving device performance metrics such as sensitivity, specificity, accuracy, or any form of clinical trial with human subjects where these metrics would be relevant.

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing (mechanical testing) and by showing that the new components are identical in terms of material, indications for use, and intended use, and that performance specifications are met. Therefore, many of the requested elements about clinical study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new components are based on demonstrating mechanical equivalence to existing predicate devices under specific ASTM standards.

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Conclusion
Mechanical Performance	Compression Fatigue (ASTM 1717-12)	Performed on subject tapered rods. The submission concludes that the subject devices demonstrated substantial equivalence to the previously listed predicate devices based on the results of the risk analysis and supporting documentation.
	Static Compression (ASTM 1717-12)	Performed on subject tapered rods. Results contribute to the conclusion of substantial equivalence.
	Static Torsion (ASTM 1717-12)	Performed on subject tapered rods. Results contribute to the conclusion of substantial equivalence.
Design Differences	New components (lengths, diameters, overall design profile) do not present a worst-case scenario compared to predicates with respect to mechanical performance.	Mechanical testing was not required for pre-cut/pre-bent rods, threaded rods, dominoes, crosslinks, or plates, because the differences were limited to additional lengths and diameters, which were determined not to present a worst-case scenario. This implies these design variations met the inherent safety/performance of the predicates.
Material Equivalence	Identical medical grade materials as predicate devices.	The document states, "The subject and predicate parts are identical in terms of material..." The system is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium.
Indications for Use	Identical indications for use as predicate devices.	The document states, "...indications for use... are substantially equivalent to predicate VERTEX® Reconstruction System devices..." and "The subject and predicate parts are identical in terms of material, indications for use, intended use..."
Intended Use	Identical intended use as predicate devices.	The document states, "The subject and predicate parts are identical in terms of material, indications for use, intended use..."
Labeling	Identical labeling as cleared predicate.	The labeling is identical to that cleared in K121191 (S.E. 06/29/12).

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the exact number of test samples (e.g., number of tapered rods) used for the mechanical tests. However, ASTM standards typically outline the minimum number of samples required for such testing.
Data Provenance: The tests were performed by Medtronic, likely in a laboratory setting, in accordance with ASTM (American Society for Testing and Materials) standards. This is a non-clinical, in-vitro study. Country of origin for data is not explicitly stated but Medtronic Sofamor Danek is based in Memphis, TN, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This submission is based on mechanical performance testing against established engineering standards (ASTM 1717-12) and comparison to predicate devices, not on clinical outcomes or expert interpretation of patient data. Therefore, no "experts" in the sense of clinical reviewers or diagnosticians were used to establish ground truth for a test set.

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

Not Applicable. As this is non-clinical mechanical testing, there is no need for adjudication as typically understood in clinical or imaging studies. Mechanical test results are objective measurements.

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

Not Applicable. This is not a study of AI or a diagnostic device involving human readers or cases. It is a 510(k) for a spinal implant system based on substantial equivalence through mechanical testing and comparison to predicate devices.

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

Not Applicable. This is not an algorithm or AI device. It's a medical implant system.

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

For the mechanical testing, the "ground truth" is defined by the performance specifications and criteria outlined in the ASTM 1717-12 standard for spinal implant assemblies. The device's performance is compared against these engineering benchmarks. For demonstrating substantial equivalence for other components, the "ground truth" is the established safety and performance of the predicate devices.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI models.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary

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VERTEX® Reconstruction System 510(k) Summary January 29, 2013

FEB 2 5 2013

l. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis. TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738

Claire Evans Contact: Senior Requlatory Affairs Specialist

Proprietary Trade Name: VERTEX® Reconstruction System II.
III. Classification Name: Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050
IV. Classification: Class II
V. Product Codes: KWP
VI. Product Description: The VERTEX® Reconstruction System is a posterior svstem, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.

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none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

VII. Indications: When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

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.

Multi-axial Screws

The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Connectors

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Summary of Technological Characteristics: The purpose of this 510(k) is VIII. to add additional components to the VERTEX® Reconstruction System. The subject and predicate parts are identical in terms of material, indications for use, intended use, and performance specifications. The key differences between the subject and predicate devices are additional lengths, diameters and overall design profile.
K123656
IX. Identification of Legally Marketed Devices: The design features, materials and indications for use of the subject devices are substantially equivalent to predicate VERTEX® Reconstruction System devices for pre-cut/pre-bent (K070742, S.E. 09/14/2007 and K080805, S.E. 04/18/2008), tapered rods (K042789, S.E. 12/21/2004, K070742, S.E. 09/14/2007 and K090714, S.E. 04/17/2009), threaded rods (K090714, S.E. 04/17/2009), dominoes (K090714, S.E. 04/17/2009), crosslinks (K082728, S.E. 01/16/2009) and OC plates (K091365, S.E. 08/06/2009).
The labeling is identical to that cleared in K121191 (S.E. 06/29/12).
Discussion of the Non-Clinical Testing: Medtronic performed compression X. fatique, static compression and static torsion on the subject tapered rods in accordance with ASTM 1717-12.
Mechanical testing was not required for the subject pre-cut/pre-bent rods, threaded rods, dominoes, crosslinks or plates since the difference between them and the predicate devices were additional lengths and diameters which do not present a worst-case scenario.

Non-clinical testing in the form of design verification and validation activities was performed on the subject devices to show equivalence to the previously listed predicate devices.

XI. Conclusions: A risk analysis was completed for the changes incorporated into the subject devices. Based on the results and additional supporting documentation provided in this submission, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Letter dated: February 25, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek USA, Incorporated % Ms. Claire Evans Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K123656

Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: K WP Dated: November 27, 2012 Received: November 28, 2012

Dear Ms. Evans:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Claire Evans

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N.Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K123656

510(k) Number (if known):

Device Name: VERTEX® Reconstruction System

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

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.

Multi-axial Screws

The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Connectors

Prescription Use × (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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123656

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.