The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis,
trauma (i.e. fractures or dislocations),
tumors, .
. deformity,
pseudarthrosis, .
. failed previous fusion,
spinal stenosis. .

Device Description

The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The ALTUM anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The ALTUM plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the ALTUM Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the ALTUM Anterior Cervical Plate System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from ASTM F1717-09)	Reported Device Performance
Mechanical Performance	Static Compression Bending (Strength)	Equal to or higher than predicate systems
Mechanical Performance	Static Torsion (Strength)	Equal to or higher than predicate systems
Mechanical Performance	Dynamic Compression Bending (Fatigue/Durability)	Equal to or higher than predicate systems

Note: The document does not specify numerical acceptance criteria from ASTM F1717-09, only that the device's performance was compared to predicate systems.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test, but standard for mechanical testing involves multiple test specimens to ensure statistical validity.
Data Provenance: The tests are non-clinical (laboratory-based mechanical tests). There is no patient data involved, so country of origin or retrospective/prospective status is not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable. For mechanical tests of spinal implants, the "ground truth" is established by the specifications and performance characteristics defined in the ASTM standard (ASTM F1717-09) and the characteristics of the predicate devices. There are no "experts" in the sense of clinical specialists establishing ground truth for individual test outcomes (e.g., diagnosing a condition). The experts involved would be those who developed the ASTM standard and those who critically evaluate the mechanical test methodologies and results.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical testing does not involve adjudication as seen in clinical studies or image review. The results are quantitative measurements against predefined standards and comparative data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."

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

This question is not applicable. The device is a physical medical implant (an anterior cervical plate), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence and meeting acceptance criteria for this medical device is based on:

Standardized Mechanical Test Protocols: Specifically, ASTM F1717-09 outlines the methods for testing spinal implant constructs.
Performance of Legally Marketed Predicate Devices: The ALTUM system's performance was compared directly to that of the Envision2 Anterior Cervical Plate System (K020649) and Spider Cervical Plating System (K052292). The "ground truth" for acceptable performance is considered to be the performance demonstrated by these existing, equivalent devices.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of device mechanical testing. The device is evaluated based on its physical properties and mechanical performance.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for this type of device evaluation.

Summary

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K103505

SpineCraft, LLC

510(k) Premarket Notification ALTUM Anterior Cervical Plate

MAR 1 5 2011

510(k) Summarv for the ALTUM Anterior Cervical Plate

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ALTUM Anterior Cervical Plate

Date Prepared: 11/24/210

Submitter: SpineCraft. LLC 2215 Enterprise Drive Westchester, IL 60154 USA Tel: 1 708-531-9700. Fax: 1708- 531-9702

Establishment Registration No: Trade name: Common Name: Classification Name:

Product Code: Classification Panel: Contact Person: Ami Akallal-Asaad Director of Regulatory Affairs. SpineCraft, LLC a.asaad@spinecraft.com

3004717358 ALTUM Anterior Cervical Plate System Anterior Cervical Plate Spinal intervertebral body fixation orthosis Per 21 CFR 88.3060 KWQ Class II 87

Predicate or legally marketed devices which are substantially equivalent:

Envision2 Anterior Cervical Plate System (K020649) / Ortho Development Spider Cervical Plating System (K052292) / X-Spine Systems

Description of the device:

Materials:

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K103505

SpineCraft, LLC

Ti-6Al-4V per ASTM F136

Function:

The ALTUM Anterior Cervical Plate system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion.

Substantial equivalence claimed to predicate devices

ALTUM Anterior Cervical Plate system is substantially equivalent to the Envision2 Anterior Cervical Plate System (K971730) and Spider Cervical Plating System (K052292) in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the ALTUM Anterior Cervical Plate system to these predicate devices.

DeviceNameItems	ALTUM AnteriorCervical Plate	Envision2 AnteriorCervical PlateSystem	Spider CervicalPlating System
Sponsor	SpineCraft	Ortho Development	X-Spine Systems
510(k)Number	Current submission	K020649	K052292
DeviceClassificationName/ProductCodes	Spinal intervertebralbody fixation orthosisper 21 CFR 88.3060KWQ	Spinal intervertebralbody fixation orthosisper 21 CFR 88.3060KWQ	Spinal intervertebralbody fixation orthosisper 21 CFR 88.3060KWQ
Classification	II	II	II
Material	Ti-6Al-4V per ASTMF136	Ti-6Al-4V per ASTMF136	Ti-6Al-4V per ASTMF136
# levels	multiple	multiple	multiple
Graft window	Yes	Yes	Yes
Variable anglescrew	Yes	Yes	Yes
Fixed screw	Yes	Yes	Yes
Screw size	Ø4.0, Ø4.5mmvariety of lengths	Ø4.0, Ø4.35mmvariety of lengths	Ø4.0, Ø4.25mmvariety of lengths
Pre-lordosed	Yes	Yes	Yes
Sterility	Non-sterile, sterilizedat hospital	Non-sterile, sterilizedat hospital	Non-sterile, sterilizedat hospital

Figure (5)

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K103505

510(k) Premarket Notification ALTUM Anterior Cervical Plate

Intended Use:

degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis, �
trauma (i.e. fractures or dislocations), �
tumors, .
. deformity,
pseudarthrosis, .
. failed previous fusion,
spinal stenosis. .

Non-clinical Test Summary:

The following tests were conducted:

ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectorny Model. Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests. The results of this testing were compared to predicate systems, with the results being equal or higher than the predicate systems.

Clinical Test Summary

No clinical studies were performed

Conclusions Nonclinical and Clinical

The ALTUM Anterior Cervical Plate System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right. The bird is drawn with simple, flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

SpineCraft, LLC % Ms. Ami Akallal-Asaad Director of Requlatory Affairs 2215 Enterprise Drive, Suite 1504 Westchester, Illinois 60154

MAR 1 5 2011

Re: K103505

Trade/Device Name: ALTUM Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: February 28, 2011 Received: March 01, 2011

Dear Ms. Akallal-Asaad:

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. Ilisting 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

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Page 2 – Ms. Akallal-Asaad

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.

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/CDRHQffices/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 (8:00) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aling B. n.t
for

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

Enclosure

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A. Indication for Use Statement

KIO3505 510(k) Number (if known): __ Device Name: ALTUM Anterior Cervical Plate System

Indication for Use:

degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
spondvlolisthesis. .
trauma (i.e. fractures or dislocations), .
tumors. .
deformity, .
pseudarthrosis.
failed previous fusion.
spinal stenosis.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KID3505 510(k) Number_

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.