Juliet® Ti

K153621 · Spineart · MAX · Jul 15, 2016 · Orthopedic

Device Facts

• Record ID: K153621
• Device Name: Juliet® Ti
• Applicant: Spineart
• Product Code: MAX · Orthopedic
• Decision Date: Jul 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Juliet® Ti PO, OL & TL lumbar interbody devices are 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 L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Juliet® Ti is a range of intervertebral body spacers designed for lumbar fusion procedures via open posterior or transforaminal approaches. Implants are additively manufactured from titanium alloy, featuring both solid and porous structures to facilitate bone ingrowth. The device is used by surgeons in an operating room setting to restore disc height and provide stability in conjunction with supplemental fixation and bone graft (autogenous or allogenic). The variety of lengths, widths, heights, and lordotic angles allows for anatomical adaptation to individual patient conditions. The device is supplied sterile for single use, while associated surgical instruments are reusable and provided non-sterile. Clinical benefit is derived from the stabilization of the spinal segment to promote fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical performance validated via static and dynamic axial compression (ASTM F2077), static and dynamic shear compression (ASTM F2077), and subsidence (ASTM F2267). Porous structure characterization performed via static shear strength (ASTM F1044), fatigue shear strength (ASTM F1160), static tensile strength (ASTM F1147), and abrasion resistance (ASTM F1978). Material properties characterized per ASTM F3001 and ASTM E8/E8M.

Technological Characteristics

Intervertebral body fusion device made of Ti6Al4V ELI titanium alloy (ASTM F136). Additively manufactured with solid and porous structures. Dimensions vary by length, height, width, and lordotic angle. Gamma sterilization. Standalone implant used with supplemental fixation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine (L2-S1) at one or two contiguous levels, 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

• Cascadia Interbody System (K150481)
• Dynamik intervertebral body fusion device (renamed Juliet) (K081888)
• JULIET PO (K142277)
• Capstone Control Spinal System (K120368)
• Capstone Spinal System (K133650)
• LUCENT (K071724)

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

July 15, 2016

SPINEART Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20, route de Pré-Bois - CP1813 1215 Geneva. SWITZERLAND

Re: K153621

Trade/Device Name: Juliet® Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 13, 2016 Received: June 15, 2016

Dear Mr. Pennesi:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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" (21CFR 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 yours,

# 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.

K153621

Page 1 of 1

510(k) Number (if known) K153621

Device Name Juliet® Ti

#### Indications for Use (Describe)

Juliet® Ti PO, OL & TL lumbar interbody devices are indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Zane W. Wyatt Division of Orthopedic Devices

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."

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Traditional 510k JULIET * Ti

Image /page/3/Picture/1 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a butterfly above the word. The butterfly is purple, and the word "spineart" is in a dark color, with the "a" and "r" in a lighter shade of purple.

### 510(k) SUMMARY

| Submitted by | SPINEART |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | International Center Cointrin |
| | 20 route de pré-bois |
| | CP1813 |
| | 1215 GENEVA 15 |
| | SWITZERLAND |
| Contacts | Franck PENNESI Director of Industry & Quality |
| | Phone : [phone] Fax : [phone] |
| | Mail : [e-mail] |
| | Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) |
| | Mail : [e-mail] |
| Date Prepared | June 13, 2016 |
| Common Name | Intervertebral body fusion device |
| Trade Name | JULIET ® Ti |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Primary predicate: Cascadia Interbody System (K150481) manufactured by K2M, |
| | Inc |
| | Additional predicates: Dynamik intervertebral body fusion device (renamed |
| | Juliet) (K081888) manufactured by Spineart; JULIET PO (K142277) manufactured |
| | by Spineart; Capstone Control Spinal System (K120368) manufactured by |
| | Medtronic Sofamor Danek Usa, In; Capstone Spinal System (K133650) |
| | manufactured by Medtronic Sofamor Danek Usa, In; LUCENT (K071724) |
| | manufactured by Spinal Elements, Inc |
| Indications for use | Juliet® Ti PO, OL & TL lumbar interbody devices are indicated for intervertebral<br>body fusion procedures in skeletally mature patients with degenerative disc<br>disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1.<br>DDD is defined as discogenic back pain with degeneration of the disc confirmed<br>by patient history and radiographic studies. These DDD patients may also have up<br>to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal<br>implants are to be used with autogenous bone graft and/or allogenic bone graft<br>comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar<br>interbody devices are to be used with supplemental fixation that has been<br>cleared for use in the lumbosacral spine. Patients should have at least six (6)<br>months of non-operative treatment prior to treatment with an intervertebral<br>cage. |
| Description of the device | Spineart Juliet® Ti PO, OL & TL spinal implants consist of a range of intervertebral<br>body spacers with various shapes and designs so as to be implanted via an open<br>posterior or transforaminal approach and to adapt different patient's conditions.<br>Spineart JULIET® Ti cage is offered in a variety of lengths, heights, widths and<br>lordotic angles to adapt to a variety of patient anatomies.<br>Juliet® Ti PO, OL & TL spinal implants are made of Titanium alloy Ti6Al4V ELI<br>conforming to ASTM F136. Juliet® Ti PO, OL & TL spinal implants are additively<br>manufactured and present both solid and porous structures.<br>The Juliet Ti cages are delivered sterile (gamma sterilization) and supplied with<br>surgical instruments (reusable - provided non-sterile). |
| of<br>Summary<br>Technological<br>Characteristics | The subject JULIET Ti device is identical in indications for use, surgical technique,<br>manufacturing method and raw material to the predicate device cleared in<br>K150481. The subject JULIET Ti device shares similar design features, comparable<br>heights, widths, depths, lordotic angles and surgical instrumentation as the<br>predicate devices (K081888, K142277, K120368, K133650, K071724). |
| Discussion of Testing | Testing in compliance with: FDA's "Class II Special Controls Guidance Document:<br>Intervertebral Body Fusion Device" was performed for the JULIETⓇ Ti Cages and<br>demonstrated substantially equivalent performance to the identified predicate<br>devices. The following mechanical tests were performed: Static and dynamic axial<br>compression (per ASTM F2077), Static and dynamic Shear compression (per<br>ASTM F2077), Subsidence (per ASTM F2267)<br>The characterization of the chemical, physical and mechanical properties of the<br>material was performed in accordance with ASTM F3001 and ASTM E8/E8M.<br>The porous structure featured on titanium alloy implants additively<br>manufactured was performed based on the FDA's Guidance for industry on the<br>testing of metallic plasma sprayed coatings on orthopedic implants to support<br>reconsideration of postmarket surveillance requirements. The following tests<br>were performed: Static shear strength (per ASTM F1044), Fatigue shear strength<br>(per ASTM F1160) Static tensile strength (per ASTM F1147) and abrasion<br>resistance (per ASTM F1978). |
| Conclusion | Based on the design features, the use of established well known materials,<br>feature comparisons, indications for use, and results of the mechanical testing,<br>the JULIET Ti has demonstrated substantial equivalence to the identified<br>predicate devices. |

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