Who is the manufacturer of HALF DOME Posterior Lumbar Interbody System?

Astura Medical, LLC filed the 510(k) submission for HALF DOME Posterior Lumbar Interbody System (K182877).

What is the FDA product code for HALF DOME Posterior Lumbar Interbody System?

MAX. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for HALF DOME Posterior Lumbar Interbody System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HALF DOME Posterior Lumbar Interbody System?

Globus Medical Rise® Intervertebral Body Fusion Device (K113447); Spinal Elements Lucent Spacer (K071724, K081968); Globus Medical Caliber® Spacers (K102293, K123231); Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947).

Who can help prepare an FDA 510(k) submission like HALF DOME Posterior Lumbar Interbody System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HALF DOME Posterior Lumbar Interbody System

K182877 · Astura Medical, LLC · MAX · May 3, 2019 · Orthopedic

Device Facts

Record ID	K182877
Device Name	HALF DOME Posterior Lumbar Interbody System
Applicant	Astura Medical, LLC
Product Code	MAX · Orthopedic
Decision Date	May 3, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3080
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The HALF DOME POSTERIOR LUMBAR INTERBODY SYSTEM is indicated for intervertebral body fusion procedures in skeletally 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 discogenc 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 SYSTEM 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

Half Dome Posterior Lumbar Interbody System; intervertebral body fusion implants; replaces autogenous bone graft blocks; hollow center for autogenous bone graft placement; superior/inferior surfaces open for endplate contact; promotes arthrodesis; used in conjunction with supplemental spinal fixation instrumentation; available in various footprints/heights; surgical implantation by physician; benefits include avoidance of bone graft donor site complications (e.g., chronic pain, hematoma, infection).

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic compression (ASTM F2077), static and dynamic shear (ASTM F2077), and subsidence testing (ASTM F2267).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136, Nitinol #1 per ASTM F2063. Design: Hollow intervertebral cage with open superior/inferior surfaces for bone graft containment and endplate contact. 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. 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

Globus Medical Rise® Intervertebral Body Fusion Device (K113447)
Spinal Elements Lucent Spacer (K071724, K081968)
Globus Medical Caliber® Spacers (K102293, K123231)
Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947)

Related Devices

K172947 — HALF DOME Posterior Lumbar Interbody System · Astura Medical · Apr 18, 2018
K150847 — Foundation Interbody Devices · Corelink, LLC · Aug 13, 2015
K152512 — Half Dome Posterior Lumbar Interbody System · Astura Medical · Jan 28, 2016
K163481 — HALF DOME Posterior Lumbar Interbody System · Astura Medical · May 3, 2017
K192006 — SIRION Lateral Lumbar Interbody System · Astura Medical, LLC · Apr 2, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ May 3, 2019 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. Astura Medical, LLC Parker Kelch Quality Manager 3186 Lionshead Ave, Suite 100 Carlsbad, California 92010 Re: K182877 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 8, 2019 Received: April 9, 2019 Dear Mr. Kelch: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182877 Device Name HALF DOME POSTERIOR LUMBAR INTERBODY SYSTEM Indications for Use (Describe) The HALF DOME POSTERIOR LUMBAR INTERBODY SYSTEM is indicated for intervertebral body fusion procedures in skeletally 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 discogenc 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 SYSTEM 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. | 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. 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." {3}------------------------------------------------ ## 510(k) Summary | Date Prepared | October 12, 2018 | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By | Astura Medical 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 Phone: 760-814-8047 | | Contact | Parker Kelch Email: quality@asturamedical.com | | 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 Device | Globus Medical Rise® Intervertebral Body Fusion Device (K113447) | | Secondary Predicate Device | Spinal Elements Lucent Spacer (K071724, K081968) Globus Medical Caliber® Spacers (K102293, K123231) Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947) | | Device Description | The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation. | | Materials | Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Nitinol #1 per ASTM F2063 | | Substantial Equivalence Claimed to Predicate Devices | The Half Dome Posterior Lumbar Interbody System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances. | | Indications for Use | The Half Dome Posterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally 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 or retrolisthesis 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. | | Non-clinical Test Summary | The following analyses were conducted: • Static and dynamic compression per ASTM F2077 • Static and dynamic shear testing per ASTM F2077 • Subsidence per ASTM F2267 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 | | Conclusion | Astura Medical considers the Half Dome expandable 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. | {4}------------------------------------------------