HALF DOME Posterior Lumbar Interbody System

K163481 · Astura Medical · MAX · May 3, 2017 · Orthopedic

Device Facts

• Record ID: K163481
• Device Name: HALF DOME Posterior Lumbar Interbody System
• Applicant: Astura Medical
• Product Code: MAX · Orthopedic
• Decision Date: May 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Half Dome Posterior Lumbar Intervertebral body fusion body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Intervertebral body fusion device; used in lumbar spine surgery. Implants feature hollow center for autogenous bone graft placement; available in various footprints/heights to match patient anatomy. Designed for use with supplemental spinal fixation instrumentation. Implanted by surgeons in clinical/OR settings to facilitate fusion in patients with degenerative disc disease. Provides structural support to disc space; promotes bone growth through graft containment. Benefits patients by stabilizing spinal segments and reducing discogenic pain.

Clinical Evidence

No clinical studies were performed. Equivalence established via non-clinical bench testing including static/dynamic compression (ASTM F2077), subsidence (ASTM F2267), and push-out testing.

Technological Characteristics

Materials: Vestakeep i4R PEEK (ASTM F2026), Tantalum (ASTM F560), Titanium alloy Ti-6Al-4V ELI (ASTM F136). Form factor: Intervertebral cage with hollow center for bone graft. Mechanical testing per ASTM F2077 and F2267.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with lumbar degenerative disc disease (DDD) at 1-2 contiguous levels (L1-S1). Includes patients with up to Grade I spondylolisthesis or retrolisthesis. Requires 6 months prior non-operative treatment; must be used with autogenous bone graft and supplemental fixation.

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

• Half Dome Posterior Lumbar Interbody System (K152512)
• ALTA Cervical Interbody Spacer (K160154)
• Next OrthoSurgical InterForm Interbody Cage System (K131082)
• Titan Spine Endoskeleton TT IBD (K083714)
• Titan Spine Endoskeleton TO Interbody Fusion Device (K102067)

Submission Summary (Full Text)

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

May 3, 2017

Astura Medical Troy Taylor Manager of Quality and Regulatory Affairs 5670 El Camino Real, Suite B Carlsbad, California 92008

Re: K163481

Trade/Device Name: Half Dome Posterior Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 5, 2017 Received: April 6, 2017

Dear Mr. Taylor:

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 devicerelated 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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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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] 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

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

510(k) Number (if known)

K163481 Page 1 of 1

Device Name

Half Dome Posterior Lumbar Interbody System

#### Indications for Use (Describe)

The Half Dome Posterior Lumbar Intervertebral body fusion body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(k) Summary

| Date Prepared | 12/06/2016 |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Astura Medical |
| | 5670 El Camino Real, Suite B |
| | Carlsbad, CA 92008 |
| | Phone: [phone] |
| Contact | Troy Taylor |
| | Email: [e-mail] |
| Trade Name | Half Dome Posterior Lumbar Interbody System |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | Half Dome Posterior Lumbar Interbody System (K152512) |
| Secondary Predicate<br>Device | ALTA Cervical Interbody Spacer (K160154) |
| | Next OrthoSurgical InterForm Interbody Cage System (K131082) |
| | Titan Spine Endoskeleton TT IBD (K083714) |
| | Titan Spine Endoskeleton TO Interbody Fusion Device (K102067) |
| Device Description | The Half Dome Posterior Lumbar Interbody devices are implants developed for<br>the substitution of the classical autogenous bone graft blocks They are<br>available in a range of footprints and heights to suit the individual pathology<br>and anatomical conditions of the patient. The implants have a hollow center to<br>allow placement of autogenous bone graft. The Half Dome cages are designed<br>to be used in conjunction with supplemental spinal fixation instrumentation. |
| Materials | Vestakeep®i4R PEEK per ASTM F2026 |
| | Tantalum per ASTM F560 |
| | Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The Titanium Half Dome Posterior Lumbar Interbody System is substantially<br>equivalent to the predicate devices in terms of intended use, design, materials<br>used, mechanical safety and performances. |
| Indications for Use | The Half Dome Posterior Lumbar Interbody System is indicated for<br>intervertebral body fusion procedures in skeletally mature patients with<br>degenerative disc disease (DDD) of the lumbar spine at one or two contiguous<br>levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with<br>degeneration of the disc confirmed by history and radiographic studies. These<br>DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at<br>the involved level(s). Half Dome implants are to be used with autogenous bone<br>graft and supplemental fixation. Patients should have at least six (6) months of<br>non-operative treatment prior to treatment with an intervertebral cage. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>● Static and dynamic compression per ASTM F2077<br>● Subsidence per ASTM F2267<br>● Push Out per ASTM F-04.25.02.02 DRAFT |
| | The results of these evaluations indicate that the Titanium Half Dome implants are equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical and Clinical | Astura Medical considers the Half Dome Posterior Lumbar Interbody System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. |

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