Arco™-SA Lumbar Cage System

K173082 · Neurostructures, Inc. · OVD · Mar 29, 2018 · Orthopedic

Device Facts

• Record ID: K173082
• Device Name: Arco™-SA Lumbar Cage System
• Applicant: Neurostructures, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Mar 29, 2018
• Decision: SESE
• Submission Type: Traditional
• 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) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with 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 or 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.

Device Story

Arco™-SA Lumbar Cage System is an intervertebral fusion device for ALIF procedures. Device consists of PEEK cages, titanium screws, and tantalum markers. Cages are implanted via open anterior approach and packed with bone graft to facilitate spinal fusion. Hyperlordotic implants (≥20°) require supplemental fixation; implants <20° may be used with integrated fixation screws alone. Device provides structural support to the intervertebral space to promote fusion in patients with degenerative disc disease. Used by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Testing included static axial compression, static compressive shear, dynamic axial compression, dynamic compressive shear, static subsidence, and static expulsion per ASTM F2077-11, ASTM F2267-04, and ASTM DRAFT F-04.25.02.02.

Technological Characteristics

Materials: PEEK (ASTM F2026), titanium (ASTM F136), tantalum markers (ASTM F560). Dimensions: Heights 12-22mm, widths 28-38mm, lengths 24-29mm. Screws: 5.0-6.0mm diameter, 20-35mm length. Lordosis: 7-30°. Mechanical testing per ASTM F2077, F2267.

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, including those with up to 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

• Lumbar Interbody Implants (K161230)
• SYNFIX Lateral/SynFix-LR System (K131276)
• IBFD (K133967)
• Implant Systems (K132421)
• Stand-Alone ALIF System (K131122)
• MIDLINE IITM (K150643)
• Lumbar System (K120966)

Reference Devices

• Cortina™ Lumbar Cage System (K171914)

Submission Summary (Full Text)

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March 29, 2018

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

Re: K173082

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: February 21, 2018 Received: February 22, 2018

Dear Ms. 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. 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 (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or 301-796-7100).

Sincerely,

# Vincent J. Devlin -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) K173082

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) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with 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 or 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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| 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 | 15 February 2018 |
| 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 §888.3080 Device Classification |
| Product Code | OVD |
| Classification Panel | Division of Orthopedic Devices |

### 510(K) SUMMARY

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Arco™-SA Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F136, and 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 Lumbar Cage System is offered in heights of 12-22mm, widths of 28- 38mm, and lengths of 24-29mm. 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°.

### 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 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 or 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.

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The indications for use for the Arco™-SA Lumbar Cage System is similar to that of the Table 5-1: Predicate Devices.

### 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 ●

| 510k<br>Number | Trade or Proprietary or Model<br>Name | Manufacturer | Predicate Type |
|----------------|---------------------------------------|-----------------|----------------|
| K161230 | Lumbar Interbody Implants | NuVasive® | Primary |
| K131276 | SYNFIX Lateral/SynFix-LR System | Synthes | Additional |
| K133967 | IBFD | Aurora Spine | Additional |
| K132421 | Implant Systems | Aesculap® | Additional |
| K131122 | Stand-Alone ALIF System | Renovis | Additional |
| K150643 | MIDLINE IITM | Centinel Spine | Additional |
| K120966 | Lumbar System | Depuy | Additional |
| K171914 | Cortina™ Lumbar Cage System | NeuroStructures | Reference |

#### Table 5-1: Predicate Devices

## PERFORMANCE DATA

The Arco™-SA Lumbar Cage System has been tested in the following test modes:

- Static axial compression per ASTM F2077-11 ●
- Static compressive shear per ASTM F2077-11 ●
- Dynamic axial compression per ASTM F2077-11 ●
- Dynamic compressive shear per ASTM F2077-11 o
- Static subsidence per ASTM F2267-04 o
- Static expulsion per ASTM DRAFT F-04.25.02.02 ●

The results of this non-clinical testing show that the strength of the Arco™-SA Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

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## CONCLUSION

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