(340 days)
Not Found
No
The description focuses on patient-matched design based on imaging data and additive manufacturing, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning.
Yes
The device is indicated for lumbar spinal fusion procedures in patients with degenerative disc disease, which is a treatment for a medical condition.
No
The device is an intervertebral cage used for spinal fusion procedures, not for diagnosing medical conditions.
No
The device description explicitly states the device is an "intervertebral lumbar device" manufactured from "titanium alloy" using an "additive manufacturing process," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The UNiD Patient-matched PLIF cage is an implantable device used in lumbar spinal fusion surgery. It is designed to be surgically placed within the body to aid in bone fusion.
- Lack of Diagnostic Testing: The description focuses on the device's physical properties, manufacturing process, and its role in a surgical procedure. There is no mention of it being used to analyze biological samples or provide diagnostic information.
- Input Imaging Modality: While it uses imaging data (X-Ray, MRI, CT), this data is used for planning and manufacturing the patient-matched implant, not for performing a diagnostic test on a biological sample.
Therefore, the UNiD Patient-matched PLIF cage falls under the category of a surgical implant or medical device used in a therapeutic procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form 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 bone graff.
UNiD Patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the anatomy of an individual patient from patient imaging data (X-Ray, MRI, CT). The implant is manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Function:
- To provide immobilization and stabilization of posterior spinal segments
- to increase 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
Major dimensions which can be adapted:
- Anterior and posterior heights
- Lordosis
- Length
- Width
- Patient-matched endplates
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray, MRI, CT
Anatomical Site
lumbar spinal segments, L2-S1
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)
Non-clinical Test Summary:
Testing was performed on the system following the protocols outlined in ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and in the ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression".
The following tests were conducted: Static Compression-shear, Dynamic Compression, Dynamic Compression-shear and Subsidence test.
Clinical Test Summary:
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medicrea International S.A. Mr. David Ryan Chief Operation Officer 5389 route de Strasbourg - Vancia Rillieux-la-Pape 69140 France
Re: K182158
Trade/Device Name: UNiD Patient-matched PLIF cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 11, 2019 Received: June 13, 2019
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.
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
July 15, 2019
1
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 (OS) 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 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,
for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182158
Device Name
UNiD Patient-matched PLIF cage
Indications for Use (Describe)
UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form 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 bone graff.
UNiD Patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
| 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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3
510(k) SUMMARY MEDICREA INTERNATIONAL's UNiD Patient-matched PLIF cage
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the UNiD Patient-matched PLIF cage:
Date Prepared: July, 30, 2018
-
- Submitter:
MEDICREA INTERNATIONAL 5389 route de Strasbourg – Vancia RILLIEUX-LA-PAPE 69140 FR
- Submitter:
Contact Person: David RYAN MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR
-
- Trade name: UNiD Patient-matched PLIF cage
Common name : UNiD patient-matched PLIF cage
- Trade name: UNiD Patient-matched PLIF cage
Regulatory Identification/ Classification
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:
-
· MEDICREA INTERNATIONAL, IMPIX 3D printed cage (K163595)
Additional predicate: -
· MEDICREA INTERNATIONAL, UNiD Patient Specific 3D Printed cage (K173782)
4. Description of the device:
The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the anatomy of an individual patient from patient imaging data (X-Ray, MRI, CT). The implant is manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Function:
The UNiD patient-matched PLIF cage is developed as an implant:
4
- To provide immobilization and stabilization of posterior spinal segments
- to increase 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
Major dimensions which can be adapted:
- Anterior and posterior heights
- Lordosis
- Length
- Width
- Patient-matched endplates
5. Indication for Use
The UNiD patient-matched PLIF cage is designed individually for each patient and indicated for intervertebral body 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.
The UNiD patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
6. Substantial equivalence claimed to predicate devices
The UNiD patient-matched PLIF cage devices are technologically similar to the already cleared MEDICREA INTERNATIONAL, IMPIX 3D printed cage (K163595) and MEDICREA INTERNATIONAL, UNiD Patient Specific 3D Printed cage (K173782) in terms of intended use, material used, mechanical safety and performances.
The table below compares the features and characteristics of the submitted UNiD patient-matched PLIF cage devices to their predicate devices.
| Device | MEDICREA INTERNATIONAL
Submit UNiD patient-
matched PLIFPLIF cage | MEDICREA INTERNATIONAL
IMPIX 3D PLIF | MEDICREA
INTERNATIONAL
UNID Patient Specific 3D
Printed cage |
|----------------|-------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------|
| 510(k) number | K182158 | K163595 | K173782 |
| Intended use | | | |
| Lumbar | Yes | Yes | Yes |
| Material | | | |
| | Titanium Alloy (Ti-6Al-
4V) according to the
ASTM F3001 | Titanium Alloy (Ti-6Al-4V)
according to the ASTM
F3001 | Titanium Alloy (Ti-6Al-
4V) according to the
ASTM F3001 |
| Caracteristics | | | |
| Shape | Rectangular anatomical
shape | Rectangular anatomical
shape | Rectangular
anatomical shape |
| | | Flat endplates | Flat endplates |
5
| Device | MEDICREA INTERNATIONAL
Submit UNiD patient-
matched PLIFPLIF cage | MEDICREA INTERNATIONAL
IMPIX 3D PLIF | MEDICREA
INTERNATIONAL
UNiD Patient Specific 3D
Printed cage |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | Patient-matched
endplates | Patient-matched
endplates | Patient-matched
endplates |
| Dimensions | Lengths: 15 to 40 mm
Heights: 6 to 20 mm
Width:
8 to 12 mm
Lordosis angles:
0° to 22°
Height strut ≤2,85mm
Width strut ≤2,5mm | Lengths: 15 to 40 mm
Heights: 6 to 20 mm
Width:
8 to 12 mm
Lordosis angles:
0° to 22°
Height strut ≤2,85mm
Width strut ≤2,5mm | Lengths: 15 to 40 mm
Heights: 6 to 20 mm
Width:
8 to 12 mm
Lordosis angles:
0° to 22°
Height strut ≤2,85mm
Width strut ≤2,5mm |
| Sterilization | Provided Sterile
(Gamma sterilized) or
non-sterile (steam
sterilization) - Single
use only | Provided Sterile (Gamma
sterilized) - Single use
only | Provided Sterile
(Gamma sterilized) or
non-sterile (steam
sterilization) - Single
use only |
7. Non-clinical Test Summary
Testing was performed on the system following the protocols outlined in ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and in the ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression".
The following tests were conducted: Static Compression-shear, Dynamic Compression, Dynamic Compression-shear and Subsidence test.
8. Clinical Test Summary
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical
MEDICREA® INTERNATIONAL UNiD patient-matched PLF cage is substantially equivalent to its predicate device in terms of indications for use, design, materials and function.