(7 days)
Not Found
No
The 510(k) summary describes a physical implant (cervical interbody fusion device) and associated instruments. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making components. The performance studies focus on mechanical testing of the screws.
Yes
The device is indicated for cervical interbody fusion procedures to treat cervical disc disease, aiming to alleviate symptoms like radiculopathy and myelopathy and promote bone fusion, which are therapeutic actions.
No
The device is an intervertebral body fusion system used for cervical spine surgery, not for diagnosing medical conditions. It is used in patients already diagnosed with cervical disc disease.
No
The device description explicitly states it is a cervical intervertebral body fusion system manufactured from Titanium alloy, consisting of cages, screws, and surgical instruments. This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (a cervical interbody fusion system) made of titanium alloy, designed to be surgically placed in the spine to promote bone fusion.
- Intended Use: The intended use is for a surgical procedure (cervical interbody fusion) to treat a specific medical condition (cervical disc disease) by physically stabilizing the spine.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys®-C ZP 3DTi device must be filled with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The Idys® C ZP 3DTi device consists of a cervical intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy and is to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The device has a shape which restores the intervertebral height and lordosis. The device contains one (1) slot to receive the bone graft to promote the fusion process between the endplates. The Idys® C ZP 3DTi is a standalone system intended to be used with two (2) bone screws, bone graft and requires no supplementary fixation. The Idys® C ZP 3DTi cages are made of compliant ASTM F3001 and ASTM F136 Titanium alloy and screws are made of ASTM F136 Titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose.
The Idys® C ZP 3DTi device consists of cages and screws, as well as associated surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical, C2-C3 disc to the C7-T1 disc
Indicated Patient Age Range
Skeletally mature patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject Idys® C ZP 3DTi screws have been tested in the following test:
- . Axial pullout load (ASTM F543)
The results of this non-clinical testing show that the subject Idys® C ZP 3DTi is substantially equivalent to legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 the FDA logo, which 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.
March 22, 2024
Clariance Magalie Hennequin Clinical & Quality & Regulatory Affairs Director 18, rue Robespierre Beaurains, 62217 France
Re: K240715
Trade/Device Name: Idys® C ZP 3DTi Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: March 13, 2024 Received: March 15, 2024
Dear Magalie Hennequin:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
K240715
Device Name
IDYS® C ZP 3DTi
Indications for Use (Describe)
The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys®-C ZP 3DTi device must be filled with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY CLARIANCE's Modified IDYS® C ZP 3DTi
Submitter
CLARIANCE 18 rue Robespierre 62217 Beaurains, France
Phone: +33(0)3 21 16 12 15 Facsimile: + 33(0)3 21 15 50 73
Contact Person: Magalie HENNEQUIN, Clinical & Quality & Regulatory Affairs Director Date Prepared: March 13th, 2024
Name of Device: Idys®C ZP 3DTi
Common or Usual Name: Intervertebral Fusion Device with Integrated Fixation, Cervical
Classification Name: Intervertebral Body Fusion Device, 21 CFR 888.3080
Regulatory Class: Class II
Product Code: OVE
Primary Predicate: IDYS® C ZP 3DTi, CLARIANCE (K212562)
Additional Predicate: Vault C Standalone Cervical Interbody Fusion System (K132029)
Device Description
The Idys® C ZP 3DTi device consists of a cervical intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy and is to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The device has a shape which restores the intervertebral height and lordosis. The device contains one (1) slot to receive the bone graft to promote the fusion process between the endplates. The Idys® C ZP 3DTi is a standalone system intended to be used with two (2) bone screws, bone graft and requires no supplementary fixation. The Idys® C ZP 3DTi cages are made of compliant ASTM F3001 and ASTM F136 Titanium alloy and screws are made of ASTM F136 Titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose.
The Idys® C ZP 3DTi device consists of cages and screws, as well as associated surgical instruments.
4
Intended Use / Indications for Use
The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys®-C ZP 3DTi device must be filled with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.
Summary of Technological Characteristics
and predicate The (K212562) devices have subject nearly identical technological characteristics and the minor differences in screw geometry do not any new issues of safety and effectiveness. Specifically, the following raise characteristics are identical between the subject and predicate:
- Same material (ASTM F136 Titanium alloy)
- Same diameters (3.5mm and 4.0mm) ●
- Same manufacturing process. ●
Performance Data
The subject Idys® C ZP 3DTi screws have been tested in the following test:
- . Axial pullout load (ASTM F543)
The results of this non-clinical testing show that the subject Idys® C ZP 3DTi is substantially equivalent to legally marketed predicate device.
Conclusions
The modified Idys® C ZP 3DTi has the same intended use and indications, principles of operation and similar technological characteristics as the cleared Idys® C ZP 3DTi (K212562). In addition, the minor technological differences between the modified Idvs® C ZP 3DTi and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the modified Idys® C ZP 3DTi is as safe and effective as the cleared Idys® C ZP 3DTi (K212562). Thus, the subject Idys® C ZP 3DTi is substantially equivalent to the cleared Idys® C ZP 3DTi (K212562).