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 SELECT® Reconstruction System is a posterior system, 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 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 neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

AI/ML Overview

Here's an analysis of the provided text regarding the VERTEX® Reconstruction System's acceptance criteria and study information:

Acceptance Criteria and Device Performance

This 510(k) submission for the VERTEX® Reconstruction System is for the addition of new components to an already cleared device. Therefore, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to the existing predicate devices rather than establishing novel performance metrics against a clinical standard.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Material Equivalence	Identical materials to predicate device.	The subject and predicate parts are identical in terms of material.	The system is fabricated from medical grade titanium, titanium alloy, and cobalt chromium. The retaining ring uses Shape Memory Alloy (Nitinol - NiTi), and some components have silicone adhesive elastomeric stakes.
Indications for Use Equivalence	Identical indications for use to predicate device.	The subject and predicate parts are identical in terms of... indications for use.	The indications for use are clearly stated for the occipitocervical, cervical, and thoracic spine (Occiput-T3) for conditions like DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors.
Intended Use Equivalence	Identical intended use to predicate device.	The subject and predicate parts are identical in terms of... intended use.	The system is a posterior system providing stabilization to promote fusion.
Performance Specifications Equivalence	Identical performance specifications to predicate device.	The subject and predicate parts are identical in terms of... performance specifications.	This implies the new components maintain the same mechanical performance characteristics as the existing system.
Mechanical Performance (New Components)	Withstand expected physiological loads; meet ASTM F1717-12 standards for compression fatigue, static compression, and static torsion.	Medtronic performed compression fatigue, static compression, and static torsion on the subject connectors in accordance with ASTM 1717-12. Non-clinical testing... demonstrated substantial equivalence of the subject devices to the predicate devices.	The study confirms the new connectors meet the relevant ASTM standards, thereby maintaining mechanical performance equivalence.
Design Features	Differences (length, angled open connection) do not negatively impact substantial equivalence.	Key differences: length and the addition of an angled open connection option. These differences were evaluated through non-clinical testing to show equivalence.	The design changes were assessed to ensure they did not introduce new safety or effectiveness concerns.

Summary of the Study:

The study conducted was a non-clinical design verification and validation activity specifically aimed at demonstrating substantial equivalence of the new components (lengths and an angled open connection option) to the previously cleared predicate devices.

Specific Information Requested:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in the provided text. The text mentions "non-clinical testing" was performed on "the subject connectors." For mechanical tests like those mentioned (compression fatigue, static compression, static torsion), specific sample sizes would typically be defined per test in the ASTM standard (ASTM F1717-12). However, the exact number of components tested is not provided.
- Data Provenance: Not applicable in the context of this 510(k). This was a non-clinical, bench-top mechanical testing study, not a clinical trial involving human patient data. Therefore, there's no country of origin or retrospective/prospective distinction for data collection in the sense of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical, mechanical testing submission. "Ground truth" in this context refers to the defined mechanical properties and performance standards (e.g., tensile strength, fatigue life) which are established by engineering specifications and industry standards (like ASTM F1717-12), not by expert medical opinion on a dataset.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical outcomes by multiple experts. This 510(k) describes mechanical bench testing, where performance is measured objectively against predefined engineering specifications.
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:
- No. This device is a surgical implant (spinal reconstruction system), not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is entirely irrelevant and was not conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is not an algorithm. It is a physical medical implant. Therefore, standalone algorithm performance is not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this submission's non-clinical testing was based on engineering specifications and compliance with recognized industry standards (ASTM F1717-12). The goal was to show that the new components met the same mechanical performance requirements as the predicate devices.
The sample size for the training set:
- Not applicable. This submission describes mechanical testing for a physical implant, not a machine learning model. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary

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APR 0 1 2013

VERTEX® Reconstruction System 510(k) Summary February 25, 2013

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

Claire Evans Contact: Senior Regulatory Affairs Specialist

Proprietary Trade Name: VERTEX® Reconstruction System II.
Classification Name: Spinal Interlaminal Fixation Orthosis, 21 CFR III. 888.3050
IV. Classification: Class II
Product Codes: KWP V.
Product Description: The VERTEX SELECT® Reconstruction System is a VI. posterior system, 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 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 neurosurgical implants,

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

Indications: When intended as an adjunct to fusion of the occipitocervical VII. 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.

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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 length and the addition of an angled open connection option.
Identification of Legally Marketed Devices: The design features, materials IX. and indications for use of the subject devices are substantially equivalent to predicate VERTEX® Reconstruction System devices cleared in K083071 (S.E. 11/14/2008) and K121191 (S.E. 06/29/12).

The labeling is identical to that cleared in K121191 (S.E. 06/29/12).

Discussion of the Non-Clinical Testing: Medtronic performed compression X. fatigue, static compression and static torsion on the subject connectors in accordance with ASTM 1717-12.
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.
Conclusions: A risk analysis and non-clinical testing was completed for the XI. changes incorporated into the subject devices. The test results and additional supporting documentation provided in this submission demonstrated substantial equivalence of the subject devices to the predicate devices cleared in K083071 (S.E. 11/14/2008).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Public Health Service

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

Letter dated: April 1, 2013

Re: K123906

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: February 25, 2013 Received: February 26, 2013

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 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 - Ms. Claire Evans

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/ReportalProblem/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/Resourcesfor You/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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K123906 510{k} Number (if known):

Device Name: VERTEX® Reconstruction System

DDD (neck pain of discogenic ongin 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

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: K123906

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.