IMPIX 3D Print cages are 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.

IMPIX 3D Print cages are 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 Description

The IMPIX 3D Print PLIF, IMPIX 3D Print TLIF, and IMPIX 3D Print TLIF-S are intervertebral lumbar devices, which consists of a variety of shapes and sizes. The implants are 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 3D printed Lumbar cage was developed as an implant:

· To provide immobilization and stabilization of anterior 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

AI/ML Overview

The provided text is a 510(k) summary for the IMPIX 3D Print Cages, an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving performance against defined acceptance criteria in the context of an AI/software device.

Therefore, many of the requested elements regarding acceptance criteria and a study proving device performance (especially for AI/software) are not applicable or cannot be extracted from this document, as it describes a physical medical device.

However, I can extract information related to the device's characteristics and the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of numerical acceptance criteria for a specific performance metric, as might be seen for a software device. Instead, it references adherence to ASTM standards for mechanical testing.

Acceptance Criterion Type	Specific Criteria (from ASTM standards) / Goal	Reported Device Performance	Comments
Mechanical Performance	Adherence to ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression".	Testing was performed following the protocols outlined in ASTM F2077 and ASTM F2267. Specific tests conducted include: Static Compression, Static Compression-shear, Dynamic Compression, Dynamic Compression-shear, Subsidence test, and Expulsion test.	The document states that testing was "performed... following the protocols," which implies the device met the requirements of these standards for the specified tests. However, it does not provide specific numerical outcomes or thresholds met for each test, only that the tests were conducted. The goal is to demonstrate "mechanical safety and performances" and that the device is "mechanically resistant to allow the fusion of the operated level."
Material Conformance	Titanium Alloy (Ti-6Al-4V) conforming to ASTM F3001 specifications.	Manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications).	The device meets the specified material standard.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated for each mechanical test. The ASTM standards would define the number of samples required for each test.
Data Provenance: The tests are non-clinical (mechanical bench testing) performed on the physical device. The country of origin for the data (where the tests were conducted) is not specified in the document, but the manufacturer is based in France. The data is prospective in the sense that these tests were conducted as part of the 510(k) submission for this specific device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This is a physical device undergoing mechanical testing, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This is mechanical testing against defined ASTM standards, not a diagnostic test requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a physical medical device, not an AI/software diagnostic tool. No MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device.

7. Type of Ground Truth Used:

For the mechanical tests, the "ground truth" is defined by the protocols and acceptance criteria within the ASTM standards (F2077 and F2267). This involves precise measurements of load, displacement, and material properties, rather than an "expert consensus" or "pathology" as would be seen for diagnostic imaging.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2017

Medicrea International S.A. Mr. David Ryan VP Product Development and Marketing 5389 route de Strasbourg 69140 Rillieux-la-Pape FRANCE

Re: K163595

Trade/Device Name: IMPIX 3D Print Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 10, 2017 Received: October 13, 2017

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163595

Device Name IMPIX 3D Print cages

Indications for Use (Describe)

IMPIX 3D Print cages are to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

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 IMPIX 3D PRINT CAGES

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Posterior Lumbar 3D Print spinal system:

Date Prepared: 09 November 2017

69140 Rillieux-La-Pape

1. Submitter:
  MEDICREA INTERNATIONAL

5389 route de Strasbourq - Vancia

Contact Person:

David RYAN MEDICREA INTERNATIONAL 5389 route de Strasbourq - Vancia 69140 Rillieux-La-Pape FR

1. Trade name: IMPIX 3D Print Cages

Regulatory Identification/ Classification

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

1. Predicate or leqally marketed devices which are substantially equivalent:

Primary predicate:

K2M Cascadia Interbody System (K150481)

Additional predicate:

MEDICREA INTERNATIONAL IMPIX-L (K072226) ●
CAPSTONE® Spinal System (K121760) o
MEDICREA IMPIX ALIF (K083798) ●
NUVASIVE INTERFIXED SYSTEM (K151214) ●

No reference devices were used in this submission

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Description of the device: 4.

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

Function: The 3D printed Lumbar cage was developed as an implant:

· To provide immobilization and stabilization of anterior 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

IMPIX 3D Print cages are 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 IMPIX 3D Print cages are technologically similar to the already cleared Lumbar Interbody Device in terms of intended use, materials used, mechanical safety and performances

K2M Cascadia Interbody System (K150481) ●
MEDICREA INTERNATIONAL IMPIX-L (K072226) ●
MEDICREA INTERNATIONAL IMPIX-L (K072226) ●
CAPSTONE® Spinal System (K121760) ●
MEDICREA IMPIX ALIF (K083798) ●
NUVASIVE INTERFIXED SYSTEM (K151214) ●

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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, Static Compression-shear, Dynamic Compression, Dynamic Compression-shear, Subsidence test, and Expulsion test

8. Clinical Test Summary 0

No clinical studies were performed. Published literature was used to demonstrate substantial equivalence.

9. Conclusions Non clinical and Clinical

MEDICREA® INTERNATIONAL IMPIX 3D Print Cages are substantially equivalent to its predicate devices in terms of indications for use, design, material and function.

Regulation Number and Section

§ 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.