Idys ALIF ZP 3DTi

K200920 · Clariance, Sas · MAX · May 29, 2020 · Orthopedic

Device Facts

Record IDK200920
Device NameIdys ALIF ZP 3DTi
ApplicantClariance, Sas
Product CodeMAX · Orthopedic
Decision DateMay 29, 2020
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3080
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided. The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion

Device Story

Intervertebral body fusion device; restores intervertebral height and lordosis; contains slots for bone graft. Used in anterior lumbar interbody fusion (ALIF) procedures; implanted by surgeons. Device consists of titanium cage and integrated fixation screws. Promotes spinal fusion in patients with degenerative disc disease. Provided sterile; single-use.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical testing per ASTM F543 for screws, and previously established biocompatibility (ISO 10993-5, -11), sterility (ISO 11737, ISO 11137), and cleaning validation.

Technological Characteristics

Material: Ti-6Al-4V ELI Titanium alloy (ASTM F3001, ASTM F136). Components: Interbody cage with integrated fixation screws. Anodized screws. Sterile, single-use. Mechanical testing standards: ASTM F543 (screws), ASTM F2077 (cages).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at 1-2 contiguous levels (L2-S1) with discogenic back pain, including up to Grade I spondylolisthesis or retrolisthesis, who failed 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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. May 29, 2020 CLARIANCE SAS % Janice M. Hogan, J.D. Regulatory Counsel Hogan Lovells US LLP 1735 Market Street. Suite 2300 Philadelphia, Pennsylvania 19103 Re: K200920 Trade/Device Name: Idys® ALIF ZP 3DTi Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: May 19, 2020 Received: May 19, 2020 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. 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 located 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/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 L. Showalter, Ph.D. Acting 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}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page 510(k) Number (if known) K200920 Device Name ldvs® ALIF ZP 3DTi Indications for Use (Describe) The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided. The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the 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 PRAStaff@fda.hhs.gov "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." FORM FDA 3881 (8/14) {3}------------------------------------------------ ### 510(k) SUMMARY CLARIANCE's Idys® ALIF ZP 3DTi Intervertebral body fusion device with bone graft ### Submitter's Name, Address, Telephone number, Contact person and Date prepared CLARIANCE SAS 18 rue Robespierre 62217 Beaurains, France Phone: + 33 (0)3 21 16 12 15 Facsimile: + 33 (0)3 21 15 50 73 Contact Person: Fadwa Bahr, Quality and Regulatory Affairs Manager Date Prepared: April 6, 2020 #### Name of Device: ldys® ALIF ZP 3DTi ### Common or Usual Name: Lumbar Intervertebral Body Fusion Device with Bone Graft #### Classification Name: Class II, 21 CFR §888.3080 - Intervertebral body fusion device, MAX #### Predicate Devices ldys® ALIF ZP 3DTi, CLARIANCE SAS (K192168): primary predicate Idys® ALIF System, CLARIANCE SAS (K172083): additional predicate (materials and instruments) SYNFIX® Evolution Secured Spacer System (K150673): cage size reference device #### Purpose of the Special 510(k) notice The Idys® ALIF ZP 3DTi device is a modification of the 510(k) cleared Idys® ALIF ZP 3DTi predicate (K192168). The modification consists of a change in the screw's design as compared to the previously cleared Idys® ALIF ZP 3DTi predicate (K192168) and the addition of cage sizes. The cages have identical design and shape as those already cleared under (K192168) for the Idys® ALIF ZP 3DTi predicate device. ### Device Description The Idys® ALIF ZP 3DTi consists of interbody fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine. The Idys® ALIF ZP 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has shape which restores the intervertebral height and lordosis. The device contains two slots to receive bone graft to {4}------------------------------------------------ promote the fusion process between the endplates. The device has to be used with bone graft. The Idys® ALIF ZP 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136. The screws are made from Ti-6AI-4V ELI per ASTM F136 and are anodized in different colors, according to their length, Idvs® ALIF ZP 3DTi cages are positioned using a set of surqical instruments common for anterior lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only. ## Intended Use/Indications for Use The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic origin back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided. The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. ## Performance Data ## Biocompatibility As there have been no changes to the manufacturing methods or patient contacting materials, no new biocompatibility testing was required to establish equivalence. Confirmatory testing per ISO 10993-5 and -11 had been performed. ## Sterility and Cleaning Repeated sterilization validation per ISO 11737 and ISO 11137 has been successfully completed. Cleaning validation has shown acceptable limits of residues. ## Mechanical Testing As the additional cage's sizes do note create a new worst case reqarding mechanical performance, no new mechanical testing according to ASTM F2077 and ASTM was required to establish equivalence to the Idys® ALIF ZP 3DTi predicate device (K192168). The screws were tested according to ASTM F543 to demonstrate and to support the decision of substantial equivalence with the primary predicate. ## Conclusions The Idys® ALIF ZP 3DTi is as safe and effective as the cleared Idys® ALIF ZP 3DTi predicate device (K192168).The Idys® ALIF ZP 3DTi has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Idys® ALIF ZP 3DTi and its predicate {5}------------------------------------------------ device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys® ALIF ZP 3DTi is as safe and effective as its predicate. Thus, the Idys® ALIF ZP 3DTi is substantially equivalent.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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