The Altus Spine Titanium Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Altus Spine Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

Device Description

The Altus Spine Titanium Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Titanium Interbody Fusion System implants are made of titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The Altus Spine Titanium Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

AI/ML Overview

This document is a 510(k) summary for the Altus Spine Titanium Interbody Fusion System (K171329). It describes the device, its intended use, and its substantial equivalence to previously cleared devices.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" (engineering analysis) that supports the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No new worst-case performance compared to the predicate device.	The engineering analysis demonstrated that the Altus Spine Titanium Interbody Fusion System does not present a new worst case in performance compared to the predicates.
Substantial equivalence to predicate devices (K170512 and K160976) in terms of function, strength, and stability.	The system is considered substantially equivalent to the predicate devices, and no new questions of safety or effectiveness are raised. This is based on the determination that the modifications (larger graft windows and an additional implant footprint) do not alter the system function, strength, and stability.
Conformance to ASTM F136 (for titanium alloy material).	The Altus Spine Titanium Interbody Fusion System implants are made of titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

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

The document mentions "Engineering analysis," not a clinical study involving human patients or a specific test set of data in the typical sense for AI/software devices. Therefore, the questions about sample size and data provenance are not applicable in the context of this device and submission. This is a medical device clearance for an implant, not an AI/diagnostic software.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the clearance is for a physical medical implant, not an AI or diagnostic device requiring expert interpretation of data to establish ground truth. The "ground truth" here is the engineering and material properties of the device itself.

4. Adjudication Method

This information is not applicable as there is no independent review of "cases" or interpretations in this type of submission.

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. This type of study is relevant for diagnostic devices where human readers interpret patient data, and AI assistance is being evaluated. This submission is for a physical orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This submission is for a physical orthopedic implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering principles and analysis: Demonstrating that changes to the device (larger graft windows, additional implant footprint) do not negatively impact its performance, strength, or stability compared to the predicate.
Material specifications: Conformance to ASTM F136 for the titanium alloy.
Established predicate device performance: The predicate devices (K170512, K160976) have already been deemed safe and effective, and the current device is shown to be substantially equivalent.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this engineering analysis for a physical medical implant.

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

This is not applicable for the same reasons as #8.

Summary

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Public Health Service

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

Altus Partners, LLC Mark Melton Senior Engineer 1340 Enterprise Drive

West Chester, Pennsylvania 19380

August 29, 2017

Re: K171329

Trade/Device Name: Altus Spine Titanium Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 12, 2017 Received: August 4, 2017

Dear Mr. Melton:

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

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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 contact the Division of Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) 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,

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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Indications for Use

510(k) Number (if known)

K171329

Device Name Altus Spine Titanium Interbody Fusion System

Indications for Use (Describe)

The Altus Spine Titanium Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).

The Altus Spine Titanium Interbody Fusion is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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8. 510(k) Summary

SUBMITTER:	Altus Partners, LLC1340 Enterprise DriveWest Chester, PA 19380Phone: 610-355-4156Fax: 610-300-3049
CONTACT PERSON:	Mark Meltonmmelton@altus-spine.com
DATE PREPARED:	August 28, 2017
COMMON NAME:	Interbody Fusion Device
PROPRIETARY NAME:	Altus Spine Titanium Interbody Fusion System
PRIMARY PREDICATE DEVICES:	Altus Spine Titanium Interbody Fusion System (K170512)
ADDITIONAL PREDICATE DEVICES:	Altus Spine Interbody Fusion System (K160976)
CLASSIFICATION NAME:	21 CFR §888.3080 Intervertebral Body Fusion Device
PRODUCT CODES:	MAX
DEVICE CLASS:	Class II
MATERIAL:	Titanium Alloy that conforms to ASTM F136

DEVICE DESCRIPTION:

The Altus Spine Titanium Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Titanium Interbody Fusion System implants are made of titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

INDICATIONS FOR USE:

The Altus Spine Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

K171329 Page 2 of 2

The Altus Spine Titanium Interbody Fusion System is a modification to the predicate (K170512). The modification includes larger graft windows and an additional implant footprint The Altus Spine Interbody Fusion System and the predicate (K073502) share the same indications for use and surgical technique. The design is essentially the same fundamental technology with minor dimensional changes.

SUMMARY OF NON-CLINAL TESTS SUBMITTED:

Engineering analysis was presented to demonstrate that the Altus Spine Titanium Interbody Fusion System does not present a new worst case in performance and is substantially equivalent to the predicates.

SUBSTANTIAL EQUIVALENCE CONCLUSION:

The Altus Spine Titanium Interbody Fusion System is the predicate (K170512) in regards to indications for use and surgical technique.

Altus Spine has determined that the modification of the Altus Spine Titanium Interbody Fusion System do not alter the system function, strength and stability. Therefore, the Altus Spine Titanium Interbody Fusion System is substantially equivalent to the predicate devices, and raises no new questions of safety or effectiveness.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.