JULIET LL

K141135 · Spineart · MAX · Dec 1, 2014 · Orthopedic

Device Facts

• Record ID: K141135
• Device Name: JULIET LL
• Applicant: Spineart
• Product Code: MAX · Orthopedic
• Decision Date: Dec 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JULIET® Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) 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). This device is to be used with autogenous bone graft. JULIET® Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage

Device Story

JULIET® LL Lateral Lumbar Cage is a rectangle-shaped intervertebral body fusion device featuring a central cavity for autogenous bone graft. Implanted during spinal fusion surgery to facilitate stabilization and fusion at L2-S1 levels. Used in conjunction with supplemental fixation. Available in various sizes, footprints, and lordotic angles to accommodate patient anatomy. Surgeon-operated in clinical/OR settings. Provides mechanical support to the intervertebral space; promotes fusion through bone graft containment. Benefits patients by addressing discogenic back pain associated with DDD.

Clinical Evidence

Bench testing only. Testing included static axial compression, static shear compression (ASTM F2077), and subsidence testing (ASTM F2267). Finite Element Analysis was also provided.

Technological Characteristics

Material: Titanium Ti 6Al-4V ELI (ASTM F136, ISO 5832-3). Form factor: Rectangle-shaped cage with central cavity. Dimensions: 25-60mm length, 8-16mm height, three widths, 0° or 6° lordosis. Sterilization: Gamma radiation. Supplied with reusable, non-sterile surgical instruments.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis. Requires at least 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

• Juliet® (K133557)
• Dynamik® (K081888)
• Nuvasive Coroent Titanium System (K120918)
• Lanx Fusion System – Lateral (K103666)
• Endoskeleton TO (K102067)
• Lucent (K071724)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of four stylized human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2014

SPINEART Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20 route de pré-bois CP1813 1215 Geneva Switzerland

Re: K141135

Trade/Device Name: JULIET® LL Lateral Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 5, 2014 Received: November 6, 2014

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

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Page 2 - Mr. Franck Pennesi

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/Resourcesfor You/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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

### Indications for Use

510(k) Number (if known)

K141135

Device Name

JULIET® LL Lateral Lumbar Cage

#### Indications for Use (Describe)

JULIET® Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) 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). This device is to be used with autogenous bone graft. JULIET® Lumbar Interbody Device is to be used with 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017

See PRA Statement below.

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

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Traditional 510k JULIET® LL Titanium Lateral Lumbar Cage

# 510(k) SUMMARY

| Submitted by | SPINEART<br>International Center Cointrin<br>20 route de pré-bois<br>CP1813<br>1215 GENEVA 15<br>SWITZERLAND |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PENNESI Director of Industry & Quality<br>Phone : [phone] Fax : [phone]<br>Mail : [e-mail]<br>Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)<br>[e-mail] |
| Date Prepared | November 26th 2014 |
| Common Name | Intervertebral body fusion device |
| Trade Name | JULIET® LL Lateral Lumbar Cage |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 21CFR 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed<br>predicate devices | Primary predicate device: Juliet® (K133557) manufactured by Spineart<br>Additional predicates include: Dynamik® (K081888) manufactured by<br>Spineart; Nuvasive Coroent Titanium System (K120918) manufactured<br>by Nuvasive; Lanx Fusion System – Lateral (K103666) manufactured by<br>Lanx; Endoskeleton TO (K102067) manufactured by Titan Spine and<br>Lucent (K071724) manufactured by Spinal Elements. |
| Indications for use | JULIET®LL Lumbar Interbody Device is indicated for intervertebral body<br>fusion procedures in skeletally mature patients with degenerative disc<br>disease (DDD) at one or two contiguous levels from L2-S1. DDD is<br>defined as discogenic back pain with degeneration of the disc confirmed<br>by patient history and radiographic studies. These DDD patients may<br>also have up to Grade 1 spondylolisthesis or retrolisthesis at the<br>involved level(s). This device is to be used with autogenous bone graft.<br>JULIET®LL Lumbar Interbody Device is to be used with supplemental<br>fixation. Patients should have at least six (6) months of non-operative<br>treatment prior to treatment with an intervertebral cage |
| Description of the device | The JULIET®LL Titanium Lateral Lumbar cages are rectangle-shaped intervertebral body fusion devices with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. The JULIET®LL intervertebral body fusion spacer comes in various sizes and footprints in order to fulfill surgeons' needs and accommodate different patient anatomies. The JULIET®LL system is made of Titanium Ti 6Al-4V ELI conforming to ASTM F136 and ISO 5832-3. |
| Technological Characteristics | The JULIET® LL Titanium Lateral Lumbar cages are available in eight lengths (from 25 to 60 mm) and six heights (from 8 to 16 mm). The JULIET® LL Titanium Lateral Lumbar cages are available in three widths and two lordosis (17mm lordosis 0°; 21mm lordosis 6° and 25mm lordosis 6°). The JULIET® LL range of lumbar implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non sterile). |
| Discussion of Testing | The following non-clinical tests were conducted on JULIET®LL Titanium Lateral Lumbar cages: Static axial compression, Static shear compression according to ASTM F2077 and subsidence testing according to ASTM F2267. A Finite Element Analysis was submitted to support substantial equivalence. The non-clinical performance testing demonstrates that JULIET®LL Titanium Lateral Lumber cage is substantially equivalent to predicate devices. |
| Conclusion | The JULIET® LL Titanium Lateral Lumbar cage is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. The results demonstrate that JULIET®LL performs as safely and effectively as its predicate devices. |

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