JULIET LL LATERAL LUMBAR CAGE

K133557 · Spineart · MAX · Feb 3, 2014 · Orthopedic

Device Facts

• Record ID: K133557
• Device Name: JULIET LL LATERAL LUMBAR CAGE
• Applicant: Spineart
• Product Code: MAX · Orthopedic
• Decision Date: Feb 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JULIET®LL 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®LL 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; designed to facilitate spinal fusion. Implanted via lateral approach in lumbar spine (L2-S1). System comprises PEEK Optima (ASTM F2026) body, Titanium 6Al-4V ELI (ASTM F136/ISO 5832-3) spikes, and Tantalum markers (ASTM F560). Available in various footprints/heights to accommodate patient anatomy. Used by surgeons in clinical settings; requires supplemental fixation. Provides structural support to intervertebral space during fusion process; benefits patients by stabilizing degenerated segments and alleviating discogenic back pain.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static axial compression, static shear compression (ASTM F2077), and subsidence testing (ASTM F2267). No clinical data provided.

Technological Characteristics

Intervertebral body fusion cage; PEEK Optima (ASTM F2026) body; Titanium 6Al-4V ELI (ASTM F136, ISO 5832-3) spikes; Tantalum markers (ASTM F560). Dimensions: 21mm width, 40-60mm length, 8-16mm height. Gamma sterilized. 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, 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

• Juliet®PO (K081888 and K101720)
• Coroent XL (K071795 and K081611)
• Capstone (K121760)
• Lanx Fusion System - Lateral (K103666)
• AVS PL PEEK AVS Plus -UniLIF (K090816)

Submission Summary (Full Text)

{0}------------------------------------------------

K133557 Page 1 of 2

# JULIET® LL

. .

# seneart.

FEB - 3 2014

# Lateral Lumbar Cage

## 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) |
| | [e-mail] |
| Date Prepared | November 12th 2013 |
| 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 | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed<br>predicate devices | Juliet®PO (K081888 and K101720) manufactured by Spineart |
| | Coroent XL (K071795 and K081611) manufactured by Nuvasive |
| | Capstone (K121760) manufactured by Medtronic |
| | Lanx Fusion System - Lateral (K103666) manufactured by Lanx |
| | AVS PL PEEK AVS Plus -UniLIF (K090816) manufactured by Stryker |
| Indications for use | JULIET®LL 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®LL Lumbar Interbody Device is to be used with supplemental |
| | fixation. Patients should have at least six (6) months of non-operative<br>treatment prior to treatment with an intervertebral cage |

{1}------------------------------------------------

K133557 Page 2 of 2

:

and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con

:

:

| Description of the device | The JULIET®LL 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 PEEK Optima conforming to ASTM F2026 with spikes made of Titanium 6Al-4V ELI conforming to ASTM F136 and ISO 5832-3 and Tantalum markers conforming ASTM F560. |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics | The JULIET® LL Lateral Lumbar cages are 21 mm wide and available in five lengths (from 40 to 60 mm) and five heights (from 8 to 16 mm). 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: Static axial compression, Static shear compression according to ASTM F2077 and subsidence testing according to ASTM F2267. Results demonstrate that JULIET®LL performs as safely and effectively as its predicate device JULIET®PO. |
| Conclusion | The JULIET® LL 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. Non clinical performance testing demonstrate that JULIET®LL is as safe, as effective, and performs as safely and effectively as its predicate devices. |

. . . . . .

.

. :

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

February 3, 2014

Spineart Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de pré-bois CP 1813 1215 Geneva 15 SWITZERLAND

Re: K133557

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 15, 2013 Received: November 19, 2013

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 or any I octar other of 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

{3}------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Page 2 - Mr. Franck Pennesi

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Vincent Jincent Javlin -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K133557

#### Device Name

#### JULIET® LL Lateral Lumbar Cage

#### Indications for Use (Describe)

JULIET®LL 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®LL 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)

[x] 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 FOR FOR FOR FOR USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

{5}------------------------------------------------

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.*

·············································································································································································· 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 [e-mail]

"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."