SIRION Lateral Lumbar Interbody System

K223335 · Astura Medical · MAX · May 9, 2023 · Orthopedic

Device Facts

• Record ID: K223335
• Device Name: SIRION Lateral Lumbar Interbody System
• Applicant: Astura Medical
• Product Code: MAX · Orthopedic
• Decision Date: May 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, 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). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior System. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the greatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation. SIRION X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.

Device Story

SIRION Lateral Lumbar Interbody System consists of interbody spacers and plates for spinal fusion; implants replace autogenous bone graft blocks to avoid donor site complications. Spacers feature hollow centers for autogenous bone graft; superior/inferior surfaces open to facilitate arthrodesis. Used in OR by surgeons; requires supplemental fixation (e.g., posterior system). Plates stabilize interbody spacers; 1-hole configuration acts as buttress. Hyperlordotic devices (>20°) require plate fixation. Implants available in various footprints/heights to match patient anatomy. Benefits include reduced donor site morbidity and stabilization of spinal segments to promote fusion.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing including static and dynamic compression, static and dynamic shear, subsidence, and expulsion testing per ASTM standards.

Technological Characteristics

Materials: Tantalum (ASTM F560), Titanium Alloy Ti6-AL4-V ELI (ASTM F136), Nitinol (ASTM E2063). Mechanical principle: Intervertebral body fusion via spacer and plate fixation. Form factor: Various footprints and heights. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine (L1-S1) at one or two contiguous levels, including those with up to Grade I spondylolisthesis or retrolisthesis. Also indicated for spine instability (T1-S1) due to fracture, tumor, scoliosis, lordosis, spinal stenosis, or failed previous surgery. Requires 6 months of prior non-operative treatment.

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

• SIRION Lateral Lumbar Interbody Fusion System (K192006)
• Half Dome (K182877, K152512)
• Spinal Elements Lucent Spacer (K071724, K081968)
• Globus Medical Rise® Intervertebral Body Fusion Device (K113447)
• Life Spine ProLift HELO (K210061)
• Amplify Surgical Dual-X (K211740)

Submission Summary (Full Text)

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May 9, 2023

Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063

Re: K223335

Trade/Device Name: SIRION Lateral Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, KWQ, OVD Dated: March 30, 2023 Received: March 30, 2023

Dear Parker 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/cfpmn/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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K223335

#### Device Name

SIRION Lateral Lumbar Interbody Fusion System

#### Indications for Use (Describe)

The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, 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). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior System. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the greatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications

Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

SIRION X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.

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

| <span></span> <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------|
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary: SIRION Lateral Lumbar Interbody Fusion

| Date Prepared | October 31st, 2022 |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Astura Medical |
| | 4949 W Royal Ln |
| | Irving, TX 75063 |
| | Phone: [phone] |
| Contact | Parker Kelch |
| | 4949 W Royal Ln |
| | Irving, TX 75063 |
| | Phone: [phone] |
| | Email: [e-mail] |
| Trade Name | SIRION Lateral Lumbar Interbody Fusion |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device – lumbar |
| Class | II |
| Product Code | MAX, OVD, KWQ |
| CFR Section | 21 CFR section 888.3080 |
| | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate Device | SIRION Lateral Lumbar Interbody Fusion System (K192006) |
| Additional Predicate<br>Device(s) | Half Dome (K182877, K152512) |
| | Spinal Elements Lucent Spacer (K071724, K081968) |
| | Globus Medical Rise® Intervertebral Body Fusion Device (K113447) |
| | Life Spine ProLift HELO (K210061) |
| | Amplify Surgical Dual-X (K211740) |
| Device Description | The Sirion Lateral 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,<br>hernias by the incision). They are available in a range of footprints and |
| | heights to suit the individual pathology and anatomical conditions of the…