Altus Spine Cervical Interbody Fusion System

K172253 · Altus Partners, LLC · ODP · Nov 21, 2017 · Orthopedic

Device Facts

• Record ID: K172253
• Device Name: Altus Spine Cervical Interbody Fusion System
• Applicant: Altus Partners, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Altus Spine Cervical 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 C3-C7. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks 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 I spondylolisthesis at the involved level(s). The Altus Spine Cervical Interbody Fusion is to be combined with cleared supplemental fixation systems, such as the Altus Cervical Plate System.

Device Story

Interbody fusion device; implanted in cervical spine (C3-C7) to facilitate fusion; hollow chamber for autogenous bone graft; superior/inferior surfaces feature teeth for stability/anti-migration. Used by surgeons in clinical settings; combined with supplemental fixation (e.g., cervical plate system). Provides structural support to spinal segment; promotes bone growth; stabilizes disc space; benefits patients with discogenic pain.

Clinical Evidence

Bench testing only. Performance evaluated via static/dynamic compression, static/dynamic compression shear, static/dynamic torsion, subsidence, and expulsion testing per ASTM F2077-14 and ASTM F2267-04 standards.

Technological Characteristics

Materials: PEEK (ASTM F2026), Tantalum (ASTM F560), Titanium alloy Ti-6Al-4V (ASTM F136). Design: Hollow chamber for bone graft; serrated superior/inferior surfaces. Mechanical testing per ASTM F2077-14 and ASTM F2267-04.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from C3-C7. DDD defined as discogenic back pain with radiographic confirmation. Requires six weeks of prior non-operative treatment. Patients may have prior non-fusion spinal surgery at involved levels and up to Grade I 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

• Alphatec Spine Novel Cervical Spinal Spacer System (K081730)
• Vertebron Interbody Fusion System (K073502)
• Altus Spine Titanium Interbody Fusion System (K170512)

Submission Summary (Full Text)

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November 21, 2017

Altus Partners, LLC Mark Melton, RA&QA 1340 Enterprise Drive West Chester, Pennsylvania 19380

Re: K172253

Trade/Device Name: Altus Spine Cervical Interbody Fusion System Regulation Number: 21 CFR 888,3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 28, 2017 Received: August 29, 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 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.

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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

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K172253

Device Name Altus Spine Cervical Interbody Fusion System

### Indications for Use (Describe)

The Altus Spine Cervical Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from C3-C7. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks 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 I spondylolisthesis at the involved level(s).

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

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 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>RA&QA<br>[e-mail] |
| DATE PREPARED: | November 20, 2017 |
| COMMON NAME: | Interbody Fusion Device |
| PROPRIETARY NAME: | Altus Spine Cervical Interbody Fusion System |
| PRIMARY PREDICATE DEVICES: | Alphatec Spine Novel Cervical Spinal Spacer System (K081730) |
| ADDITIONAL PREDICATE DEVICES: | Vertebron Interbody Fusion System (K073502) |
| | Altus Spine Titanium Interbody Fusion System (K170512) |
| | CLASSIFICATION NAME: 21 CFR §888.3080 Intervertebral Body Fusion Device |
| PRODUCT CODES: | ODP |
| DEVICE CLASS: | Class II |
| MATERIAL: | PEEK that conforms to ASTM F2026, Tantalum that conforms to<br>ASTM F560 and Titanium Alloy that conforms to ASTM F136. |

# DEVICE DESCRIPTION:

The Altus Spine Cervical 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 Cervical Interbody Fusion System implants are made of PEEK with Tantalum conforming to ASTM F2026 and ASTM F560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The Altus Spine Cervical 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 Cervical 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 C3-C7. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks 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

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retrolisthesis at the involved level(s).

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

### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of the Altus Spine Interbody Fusion System is equivalent to the predicate device (K081730). The design is essentially the same fundamental technology with minor dimensional changer that those currently FDA 510(k) approved.

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

Testing in accordance with ASTM F2077-14 and ASTM F2267-04 was preformed and demonstrated that the Altus Spine Interbody Fusion System is substantially equivalent to the predicate device.

8 different tests were conducted, which include static compression, static compression shear, static torsion, subsidence, expulsion, dynamic compression, dynamic compression shear, and dynamic torsion.

### SUBSTANTIAL EQUIVALENCE CONCLUSION:

The Altus Spine Cervical Interbody Fusion System is the predicate (K081730) in regards to indications for use and surgical technique.

Altus Spine has determined that the modification of the Altus Spine Cervical 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 device.