Arco™-SA Lumbar Cage System

K182195 · Neurostructures, Inc. · OVD · Nov 9, 2018 · Orthopedic

Device Facts

• Record ID: K182195
• Device Name: Arco™-SA Lumbar Cage System
• Applicant: Neurostructures, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Nov 9, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arco™-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) on the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental fixation system cleared by the FDA. The Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

Device Story

Intervertebral fusion device (cage) for anterior lumbar interbody fusion (ALIF); implanted via open anterior approach; packed with autograft/allograft bone graft. Provides structural support to facilitate spinal fusion. Hyperlordotic implants (≥20°) require supplemental fixation; implants <20° with internal fixation screws do not. Used by surgeons in clinical settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by comparison of material and technological characteristics to predicate devices.

Technological Characteristics

Materials: Titanium (ASTM F136) with TECOTEX® surface or PEEK (ASTM F2026) with tantalum markers (ASTM F560). Dimensions: Heights 12-22mm, widths 28-43mm, lengths 24-32mm. Screws: 5.0-6.0mm diameter, 20-35mm length. Lordosis: 7-30°. Mechanical fixation via integrated screws.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain) at one level (L2-S1) of the non-cervical spine, with or without Grade 1 spondylolisthesis or retrolisthesis, who have failed at least 6 months of 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

• Arco™ SA Lumbar Cage System (K173082)
• PILLAR® SA PTC (K161129)

Reference Devices

• Ti-Diagon Oblique TLIF (K172064)

Submission Summary (Full Text)

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November 9, 2018

Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

NeuroStructures, Inc. % Meredith May Vice President Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918

### Re: K182195

Trade/Device Name: Arco™-SA Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: October 22, 2018 Received: October 23, 2018

### Dear Meredith May:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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

(1-800-638-2041 or 301-796-7100).

Sincerely,

# David Hwang -S

For 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

510(k) Number (if known) K182195

Device Name Arco™-SA Lumbar Cage System

#### Indications for Use (Describe)

The Arco™-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) on the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental fixation system cleared by the FDA. The Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

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

| <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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# 5.510(K) SUMMARY

| Submitter's Name | Neurostructures, Inc. |
|------------------------------|-------------------------------------------------------------------------------------------------|
| Submitter's Address | 16 Technology Drive, Suite 165<br>Irvine, CA 92618 |
| Company Contact Person | Kathleen Wong<br>[e-mail]<br>949.370.4497 |
| Contact Person | Meredith L. May MS, RAC<br>Empirical Consulting<br>719-337-7579<br>[e-mail] |
| Date Summary was<br>Prepared | 29-May-18 |
| Trade or Proprietary Name | Arco™-SA Lumbar Cage System |
| Common or Usual Name | Intervertebral Fusion Device With Integrated Fixation,<br>Lumbar |
| Classification | Class II per 21 CFR §888.3050 Device Classification |
| Product Code | OVD |
| Classification Panel | Division of Orthopedic Devices |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Arco™-SA ALIF System is an intervertebral fusion device made from titanium per ASTM F136 with TECOTEX® surface from TECOMET, Inc. or medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device implant cages are offered in a variety of footprints and sizes to accommodate various patient anatomies. The Arco™-SA ALIF System is offered in heights of 12-22mm, widths of 28-43mm, and lengths of 24-32mm. The subject device implant screws are offered in Ø5.0-6.0mm diameters and lengths ranging 20-35mm. The subject device implant is offered with a lordosis of 7- 30°. The purpose of this submission is to add larger footprint options and add the titanium implants to the previously cleared system

# INDICATIONS FOR USE

The Arco™-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or

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retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA. The Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

### TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- . Principles of Operation
- Indications for Use ●
- Implant Materials ●
- Implant Sizes
- Surgical Approach .

### Table 5-1: Predicate

| 510k<br>Number | Trade or Proprietary or Model<br>Name | Manufacturer | Predicate<br>Type |
|----------------|---------------------------------------|---------------------------|-------------------|
| K173082 | Arco™ SA Lumbar Cage System | NeuroStructures | Primary |
| K161129 | PILLAR® SA PTC | Orthofix, Inc. | Additional |
| K172064 | Ti-Diagon Oblique TLIF | Camber Spine Technologies | Reference |

# PERFORMANCE DATA

A comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing.

### CONCLUSION

The overall technology and material characteristics lead to the conclusion that the Arco™-SA Lumbar Cage System is substantially equivalent to the predicate device.