Altus Spine Interbody Fusion System

K170553 · Altus Partners, LLC · MAX · Dec 1, 2017 · Orthopedic

Device Facts

• Record ID: K170553
• Device Name: Altus Spine Interbody Fusion System
• Applicant: Altus Partners, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Dec 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Interbody fusion system consisting of implants in various shapes/sizes; used to facilitate spinal fusion. Implants feature hollow chambers for autogenous bone graft packing; superior/inferior surfaces include teeth for stability/anti-migration. Tantalum wire markers provide radiographic visualization. Used by surgeons in clinical settings to treat degenerative disc disease. Implants are used in conjunction with supplemental fixation systems (e.g., pedicle screws). Benefits include stabilization of spinal segments and promotion of fusion.

Clinical Evidence

Bench testing only. Mechanical testing conducted per ASTM F2077 and ASTM F2267 for static and dynamic compression, shear compression, subsidence, and expulsion.

Technological Characteristics

Materials: PEEK (ASTM F2026), titanium alloy (ASTM F136), tantalum (ASTM F560). Features: Hollow chamber for bone graft, surface teeth for stability, tantalum wire markers for visualization. Non-active, mechanical implant.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD defined as discogenic back pain with radiographic confirmation, failing 6 months of non-operative treatment. Includes patients with prior non-fusion spinal surgery and up to Grade 1 spondylolisthesis or retrolisthesis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Altus Spine Interbody Fusion System (K160976)
• Vertebron Interbody Fusion System (K073502)

Reference Devices

• Altus Spine Pedicle Screw System

Submission Summary (Full Text)

{0}------------------------------------------------

Altus Partners, LLC Mark Melton Head Engineer 1340 Enterprise Drive West Chester, Pennsylvania 19380 December 1, 2017

Re: K170553

Trade/Device Name: Altus Spine Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 31, 2017 Received: November 1, 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 of medical device-related adverse events) (21 CFR 803); good

{1}------------------------------------------------

manufacturing practice requirements as set 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170553

Device Name Altus Spine Interbody Fusion System

#### Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 1 of 1

CONFIDENTIAL

{3}------------------------------------------------

## 8. 510(k) Summary

| | SUBMITTER: Altus Partners<br>1340 Enterprise Drive<br>West Chester, PA 19380<br>Phone: [phone]<br>Fax: [phone] |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mark Melton<br>R&D<br>[e-mail] |
| DATE PREPARED: | October 31, 2017 |
| COMMON NAME: | Interbody Fusion Device |
| PROPRIETARY NAME: | Altus Spine Interbody Fusion System |
| | PRIMARY PREDICATE DEVICES: Altus Spine Interbody Fusion System (K160976) |
| | ADDITIONAL PREDICATE DEVICES: Vertebron Interbody Fusion System (K073502) |
| | CLASSIFICATION NAME: 21 CFR §888.3080 Intervertebral Body Fusion Device |
| PRODUCT CODES: | MAX |
| DEVICE CLASS: | Class II |
| MATERIAL: | The material used is PEEK conforming to ASTM F2026, and<br>titanium alloy conforming to ASTM F136 or tantalum conforming<br>to ASTM F560. |

#### DEVICE DESCRIPTION:

The Altus Spine 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 Interbody Fusion System implants are made of Polyetheretherketone (PEEK) that conforms to ASTM F2026 (Invibio PEEK-Optima® LT1 or Solvay Specialty Polymers Zeniva™ ZA-500 PEEK), and titanium alloy conforming to ASTM F136 or tantalum conforming to ASTM F560. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Tantalum wire markers are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and poster-operatively.

The Altus Spine 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.

#### INDICATIONS FOR USE:

The Altus Spine 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

{4}------------------------------------------------

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

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The Altus Spine Interbody Fusion System and the predicate devices are substantially equivalent. The subject device is equivalent to the predicates in regards to technological characteristics, including design, intended use, material composition, and function.

#### SUMMARY OF NON-CLINAL TESTS SUBMITTED:

The substantial equivalence of the Altus Spine Interbody Fusion System devices to the predicates is shown by similarity in intended use, indications for use, materials, performance and fundamental scientific technology.

Mechanical testing was conducted in accordance to ASTM F2077 and ASTM F2267 for static and dynamic compression, shear compression, subsidence, and expulsion. The results of these tests provide justification that the new components do not introduce a new worst-case.

#### SUBSTANTIAL EQUIVALENCE CONCLUSION:

The Altus Spine Interbody Fusion System is the same as the predicate (K160976) in regards to indications for use and surgical technique.

Altus Spine has determined that the modification of the Altus Spine Interbody Fusion System do not alter the system function, strength and stability. Therefore, the Altus Spine Interbody Fusion System is substantially equivalent to the predicate devices.

#### CONFIDENTIAL