(123 days)
No
The 510(k) summary describes a lumbar intervertebral body fusion device made of titanium alloy using additive manufacturing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical testing of the implant itself.
Yes
The device is described as an intervertebral body fusion device used to promote fusion in patients with degenerative disc disease, which is a therapeutic intervention.
No
The provided text describes a medical implant (cages for spinal fusion) used for treatment, not for diagnosing conditions.
No
The device description clearly describes a physical implant (cages made of titanium alloy) used in spinal fusion surgery, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Idys™ TLIF 3DTi cages are described as implants used in spinal fusion surgery. They are surgically inserted into the body to promote bone fusion.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any specimens taken from the body. The device itself is the therapeutic intervention.
Therefore, the Idys™ TLIF 3DTi cages fall under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Idys™ TLIF 3DTi cages are indicated for use with autogenous 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 implants may be implanted via a posterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Product codes
MAX
Device Description
The Idys™ TLIF 3DTi cages, which have various widths and heights, are designed for use as a lumbar intervertebral body fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains a slot to receive the autologous bone graft to promote the fusion process between the endplates. The Idys™ TLIF 3DTi cages are made of compliant ASTM F136 Titanium alloy. The device is manufactured using an additive manufacturing process to result in a porous material with tightly defined structure. It is essential to insert implants with instrumentation specifically designed for this purpose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance testing was conducted according to ASTM F2077 and ASTM F2267. Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing, and wear testing. The results of these studies were determined to be substantially equivalent to legally marketed devices.
Key Metrics
Not Found
Predicate Device(s)
CLARIANCE, Idys TLIF Cage, K131178, K2M, CASCADIA TL, K150481
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2017
CLARIANCE, SAS % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K172465
Trade/Device Name: Idys™ TLIF 3DTi cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 17, 2017 Received: November 17, 2017
Dear Ms. 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 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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Page 2 - Ms. Janice Hogan
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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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510(k) Number (if known)
Device Name
ldys™ TLIF 3DTi
Indications for Use (Describe)
The Idys™ TLIF 3DTi cages are indicated for use with autogenous 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 implanted via a posterior and/or transforminal approach. These devices are intended to be used with supplementation, which has been cleared for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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K172465 Page 1 of 3
510(k) SUMMARY
CLARIANCE's Idys™ TLIF 3DTi
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
CLARIANCE, SAS 18 Rue Robespierre F-62217 Beaurains, FRANCE Phone: +33 (0)3 21 16 12 15 Facsimile: +33 (0)3 21 15 50 73 Contact Person: Pascal Rokegem, Chief Technology Officer
Date: December 6, 2017
Name of Device and Name
ldys™ TLIF 3DTi
Common or Usual Name
Lumbar Intervertebral Body Fusion Device
Classification Name
888.3080 - Intervertebral body fusion
Product Code
MAX
Predicate Devices
CLARIANCE, Idys TLIF Cage, K131178 (primary)
K2M, CASCADIA TL, K150481 (additional)
Intended Use / Indications for Use
The Idys™ TLIF 3DTi cages are indicated for use with autogenous 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 implants may be implanted via a posterior and/or
4
transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Device Description
The Idys™ TLIF 3DTi cages, which have various widths and heights, are designed for use as a lumbar intervertebral body fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains a slot to receive the autologous bone graft to promote the fusion process between the endblates. The Idvs™ TLIF 3DTi cages are made of compliant ASTM F136 Titanium alloy. The device is manufactured using an additive manufacturing process to result in a porous material with tightly defined structure. It is essential to insert implants with instrumentation specifically designed for this purpose.
Comparison of Technological Characteristics
The Idys™ TLIF 3DTi cages and the predicate Idys™ TLIF (K131178) are designed for use as lumbar intervertebral body fusion devices. All devices are composed of cages or "interbody spacers" available with various configurations to accommodate patient's anatomy.
The Idys™ TLIF 3DTi and the Idys™ TLIF (K131178) cages feature a similar outer shape and design. Both devices are banana-shaped with a convex design and a bulleted nose. The shape is also similar to the CASCADIA™ TL (K150481). The design features slots to allow the incorporation of bone graft which is essential to promoting the fusion process. The difference in the number of slots for autograft between the Idys™ TLIF 3DTi and Idys™ TLIF predicate (K131178) do not raise new or different issues of safety and effectiveness since the volume available for autograft is equivalent. Unlike the Idys™ TLIF cages (K131178), each of the superior and inferior surfaces of the Idys™ TLIF 3DTi cages devices do not have teeth since the roughness of the porous structure is sufficient to grip the surface of the vertebral endplates and help resist expulsion. Although there are no teeth on the superior and inferior surfaces, the expulsion testing has demonstrated adequate resistance to expulsion.
In terms of configurations, the Idys™ TLIF 3DTi cages are similar to those of the cleared ldys™ predicate (K131178). The Idys™ TLIF 3DTi cages are available with two footprints with different heights ranges and no lordotic angles.
The structure of both Idys™ TLIF 3DTi and CASCADIA™ TL (K150481) is made of porous titanium with rough surfaces in order to achieve biological fixation. Mechanical testing has shown that this structure does not have an adverse impact on the mechanical performance of the the Idys™ TLIF 3DTi cages.
Performance Data
Performance testing was conducted according to ASTM F2077 and ASTM F2267. Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing, and wear testing. The results of these studies were determined to be substantially equivalent to legally marketed devices.
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Conclusion
The Idys™ TLIF 3DTi is as safe and effective as the Idys™ TLIF (K131178) and CASCADIA™ TL (K150481). The Idys™ TLIF 3DTi has the same intended use, similar indications, principles of operation, and technological characteristics as the Idys™ TLIF (K131178) and the CASCADIA™ TL (K150481). Bench testing has shown equivalent performance. Thus, the Idys™ TLIF 3DTi is substantially equivalent.