IDYS LIF CAGES

K131178 · Clariance · MAX · Oct 10, 2013 · Orthopedic

Device Facts

• Record ID: K131178
• Device Name: IDYS LIF CAGES
• Applicant: Clariance
• Product Code: MAX · Orthopedic
• Decision Date: Oct 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by FDA for use in the lumbar spine.

Device Story

Idys™ LIF Cages are PEEK lumbar interbody fusion implants designed for surgical support and correction in the lumbar spine. Implants feature hollow geometry for autologous bone graft packing and Tantalum markers for radiographic visualization. Available in various anatomic shapes for PLIF, TLIF, and PTLIF surgical approaches. Used by orthopedic or neurosurgeons in clinical settings during intervertebral body fusion procedures. TLIF variants include a bullet tip and axle for rotational introduction via specialized instrumentation. Implants are used in conjunction with FDA-cleared supplemental fixation systems to stabilize the spine, promote fusion, and alleviate discogenic back pain.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F2077 and ASTM F2267, including static and dynamic axial compression, compression shear, subsidence, expulsion, and wear testing. Results demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Materials: INVIBIO PEEK OPTIMA LT1; Tantalum markers (ASTM F560); Titanium alloy axle (ASTM F136). Principle: Intervertebral body spacer for fusion. Form factor: Hollow cage with various widths/heights for PLIF, TLIF, PTLIF. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two levels from L2 to S1, including those with up to Grade 1 Spondylolisthesis or retrolisthesis, who have failed six 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

• Eisertech, LLC's PLIF Cage (K113478)
• K2M, Inc.'s Aleutian IBF System (K082698)
• Synthes Spine's OPAL Spacer (K072791)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

#### CLARIANCE's Idys™ LIF Cages

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

> CLARIANCE 17 rue James WATT - 2A F-62000 Dainville, FRANCE

Phone: [phone] Facsimile: [phone]

Contact Person: Pascal Rokegem, Chief Technology Officer

Date Prepared: October 9, 2013

#### Name of Device and Name/Address of Sponsor

CLARIANCE - Idys™ LIF Cages

#### Common or Usual Name

Lumbar Intervertebral Body Fusion Device

#### Classification Name

21 C.F.R. 888.3080 - Intervertebral body fusion device

#### Product Code

MAX

### Predicate Devices

Eisertech, LLC's PLIF Cage

K2M, Inc.'s Aleutian IBF System

Synthes Spine's OPAL Spacer

#### Intended Use / Indications for Use

The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by FDA for use in the lumbar spine.

OCT 10 2013

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# Device Description

:

The Idys™ LIF Cages consist of PEEK lumbar cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Idys™ LIF Cages also feature markers made of Tantalum according to ASTM F560.

The Idys™ LIF Cages have different anatomic shapes and dimensions based on the surgical approach: PLIF (posterior lumbar interbody fusion); TLIF (transforaminal lumbar interbody fusion); and PTLIF (posterior approach and oblique-TLIF approach).

The Idys™ PLIF Cage is a hollow spacer with openings for autograft on the top, bottom, and sides of the device.

the Idys™ TLIF Cage has a bullet tip to facilitate introduction. The TLIF Cage Holder instrument has a clamp that affixes to the axle to enable rotation of the device during its introduction in situ.

The Idys™ PTLIF Cage is inserted in an oblique position. It can be introduced with a PLIF approach or a TLIF approach to the convenience of the surgeon and with taking into account the profile of the patient.

The Idys™ LIF Cage procedures are performed using a set of surgical instruments common for PLIF and TLIF approaches. Most of the instruments provided are common surgical tools used in these types of interbody fusion procedures. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21 CFR 888.4540.

| | CLARIANCE's<br>Idys™ LIF, Cages | Eisertech, LLC's<br>PLIF Cage<br>(K113478) | K2M, Inc.'s<br>Aleutian IBF System<br>(K082698) | Synthes Spine's<br>Synthes OPAL<br>Spacer<br>(K072791) |
|--------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------|
| Anatomical<br>sites | L2 to S1 | L2 to S1 | L2 to S1 | L2 to S1 |
| Material | INVIBIO PEEK<br>OPTIMA LT1 | INVIBIO PEEK<br>OPTIMA or Zeniva<br>PEEK | INVIBIO PEEK<br>OPTIMA LT1 | PEEK |
| Radiographic<br>Marker<br>Components | Tantalum markers;<br>ASTM F136 Titanium<br>alloy cage axle (TLIF<br>Cage only) | Commercially pure<br>titanium markers grade<br>2, per ASTM F67 | Tantalum markers | N/A |
| Surgical<br>Approaches | PLIF, TLIF, PTLIF | PLIF | PLIF, TLIF, PTLIF | PTLIF |
| PLIF<br>Dimensions | Length: 20, 25 mm<br>Height: 8-14 mm<br>Width: 11 mm | Length: 20-30 mm<br>Height: 7-16 mm<br>Width:8-12 mm | Length: 22, 26 mm<br>Height: 7-17 mm<br>Width: 10 mm | N/A |
| TLIF<br>Dimensions | Length: 29 mm<br>Height: 7-14 mm<br>Width: 11 mm | N/A | Length: 27 mm<br>Height: 7-17 mm<br>Width: 10 mm | N/A |
| PTLIF<br>Dimensions | Length: 28, 32 mm<br>Height: 8-14 mm<br>Width: 11 mm | N/A | Length: 28, 32, 36 mm<br>Height: 7-15 mm<br>Width: 10, 12 mm | Length: 28, 32 mm<br>Height: 7-17 mm<br>Width: 10 mm |

# Comparison of Technical Characteristics

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# Performance Data

Performance testing was conducted per ASTM F2077 and ASTM F2267. Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, and wear testing. The results of these studies were determined to be substantially equivalent to legally marketed devices.

# Substantial Equivalence

The Idys™ LIF Cages are substantially equivalent to Eisertech, LLC's PLIF Cage (K113478), K2M, Inc.'s Aleutian IBF System (K082698), and Synthes Spine's OPAL Spacer (K072791). The Idys™ LIF Cages have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the Idys™ LIF Cages and its predicate devices raise no new issues. Performance data demonstrate that the Idys™ LIF Cages are substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public I lealth Service

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

October 10, 2013

CLARIANCE % Janice M. Hogan, Esq. Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K131178

Trade/Device Name: Idys™ LIF Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 30. 2013 Received: August 30, 2013

Dear Esquire Hogan:

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 docs 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

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Page 2 - Janice Hogan, Esq.

device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Safetv/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/ResourcesforYou/Industry/default.htm.

Sincercly yours.

# Erin I. Keith

for

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

Enclosure

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# Indications for Use Statement

510(k) Number (if known): ____K131178

Device Name: Idys™ LIF Cages

Indications for Use:

The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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