UNiD IB3D ALIF

K200316 · Medicrea International SA · MAX · Oct 30, 2020 · Orthopedic

Device Facts

• Record ID: K200316
• Device Name: UNiD IB3D ALIF
• Applicant: Medicrea International SA
• Product Code: MAX · Orthopedic
• Decision Date: Oct 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal 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 I Spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNID® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Device Story

Patient-matched intervertebral body fusion device; designed individually for each patient; used for anterior lumbar spinal fusion. Implant provides immobilization, stabilization, and mechanical support to facilitate fusion of spinal segments. Device is inserted between adjacent vertebrae by surgeon. Manufactured from titanium alloy; patient-specific geometry includes height, footprint, lordosis, and coronal angle; patient-matched endplates may be added. Benefits include stabilization of spinal segments and augmentation of solid fusion in DDD patients. Used in clinical settings by surgeons.

Clinical Evidence

No clinical data. Evidence consists of bench testing and Finite Element Analysis (FEA). Biocompatibility is supported by the use of identical materials and manufacturing processes as predicate devices.

Technological Characteristics

Intervertebral body fusion device; titanium alloy (Ti-6Al-4V ELI) per ASTM F3001; patient-specific geometry (height, footprint, lordosis, coronal angle); anterior approach; requires supplemental fixation and autogenous bone graft.

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 I Spondylolisthesis. Requires autogenous bone graft and supplemental fixation. Patients must have failed at least 6 months of nonoperative 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

• IB3D ALIF (K191134)

Reference Devices

• UNiD® Patient matched PLIF cage (K182158)
• UNiD® Patient Specific 3D printed cage (K173782)
• IMPIX® 3D printed cages (K163595)

Submission Summary (Full Text)

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October 30, 2020

Medicrea International S.A. David Ryan Chief Operating Officer 5389, route de Strasbourg Rillieux-la-Pape, 69140 France

Re: K200316

Trade/Device Name: UNiD® IB3D ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 30, 2020 Received: October 2, 2020

Dear Mr. Ryan:

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K200316

Device Name

UNiD® IB3D ALIF

MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal 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 I Spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

UNID® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative 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)

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# 510(k) SUMMARY MEDICREA® INTERNATIONAL's UNiD® IB3D ALIF

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the UNiD® IB3D ALIF:

Date Prepared: February 3, 2020

- 1. Submitter:
MEDIČREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR Phone: [phone] Fax: [phone]

Contact Person: David RYAN MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR

- 2. Trade name: UNiD® IB3D ALIF
# Requlatory Identification/ Classification

FDA classification name: Intervertebral Body Fusion Device with Bone Graft, lumbar Regulation Number : 21CFR 888.3080 Product Code: MAX Class II

#### 3. Predicate or legally marketed devices which are substantially equivalent:

### Primary predicate device:

- IB3D ALIF, (MEDICREA® INTERNATIONAL, K191134) .
### Reference Devices:

- o UNiD® Patient matched PLIF cage, (MEDICREA® INTERNATIONAL, K182158)
- UNiD® Patient Specific 3D printed cage (MEDICREA® INTERNATIONAL. K173782) ●
- IMPIX® 3D printed cages (MEDICREA® INTERNATIONAL, K163595) ●

Those three devices have not been subject to a design-related recall.

### 4. Description of the device:

The MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device consists of one single implant with specific heights, footprint, lordosis and coronal angle. Patient matched endplates can be added to the implant. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following ASTM F3001 standard, a radio opaque material. As any orthopaedic implants should not be reused. For a complete quide of the system, please refer to the surgical technique manual for specific instructions.

The UNiD® IB3D ALIF cage is designed for a specific patient, it must not be used for another patient.

MATERIALS: Components are manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

### Function:

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The UNiD® IB3D ALIF was developed as an implant:

- to provide immobilization and stabilization of posterior spinal segments .
- to augment the development of a solid spinal fusion ●
- . to provide stability to ease fusion
- to be mechanically resistant to allow the fusion of the operated level

# 5. Indication for Use

MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal 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 I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNiD® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

# 6. Substantial equivalence claimed to predicate devices

The UNiD® IB3D ALIF are technologically similar to the already cleared MEDICREA® INTERNATIONAL IB3D ALIF in terms of intended use, material used, mechanical safety and performances.

The table below compares the features and characteristics of the submitted UNiD® IB3D ALIF to its predicate device.

| Device | MEDICREA® INTERNATIONAL<br>UNID® IB3D ALIF | MEDICREA®<br>INTERNATIONAL<br>IB3D ALIF |
|---------------|--------------------------------------------|-----------------------------------------|
| 510(k) number | K200316 | K191134 |
| Intended use | | |
| | Lumbar | Yes |
| Approach | Anterior | Anterior |
| Material | | |
| | Raw material | Titanium Ti6Al4V ELI |
| Sterilization | | |
| | Sterilization | Provided sterile or non-sterile |

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# 7. Non-clinical Test Summary:

The following performance data was provided in support of the substantial equivalence determination.

#### Biocompatibility Testing

The UNiD® IB3D ALIF are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.

#### Mechanical testing

Finite Element Analysis (FEA) was conducted and it was determined that no new worst-case implant was created. Therefore additional testing per ASTM F2077 "Standard Test Methods for Intervertebral of Intervertebral Body Fusion Device under Static Axial Compression" was not conducted.

### 8. Conclusions

UNiD® IB3D ALIF devices are substantially equivalent to legally marketed predicate device