IMPIX-C Cervical Interbody Device is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft.

IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

IMPIX-L Lumbar Interbody Device is 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-L Lumbar Interbody Device 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.

Device Description

The IMPIX Cervical Interbody devices consist of implants with a convexity on the upper surface with anti-migration upper ridging and lower pins. The IMPIX Cervical Interbody device has a D-forro with two openings that allow the surgeon to fill it with bone graft. In order to adapt to the warying morphology of patients, both IMPIX Cervical Interbody devices are available in various sizes. The IMPIX Cervical Interbody device is machined from PEEK OPTIMA LT1.

The IMPIX Lumbar Interbody device is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the MPIX-L are open, to allow the surgently pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to adapt to the varying morphology of patients, the IMPIX Lumbar Interbody devices are available in various sizes. The IMPIX Lumbar Interbody device is machined from PEEK OPTIMA LT1.

AI/ML Overview

The IMPIX Interbody Device is a medical device and not an AI or software device. Therefore, the traditional metrics of acceptance criteria, sample size for test/training sets, ground truth establishment, expert qualifications, and MRMC studies that apply to AI/ML devices are not relevant here.

Instead, its "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices and meeting established mechanical strength standards for intervertebral body fusion devices.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Substantial Equivalence | Device must be similar in: - Design - Material - Intended Use to legally marketed predicate devices cleared by FDA for intervertebral body fusion. | The IMPIX Interbody Fusion devices are stated to be "similar in design, material, and intended use to its predicate devices that have been cleared by FDA for intervertebral body fusion." This statement directly addresses the criteria for substantial equivalence. |
| Mechanical Strength | Device must meet "required mechanical strengths" for intervertebral body fusion devices. | "Tests performed according to ASTM F2077 indicate that the IMPIX Interbody Fusion devices meet required mechanical strengths." |
| Indications for Use | The device's indications for use (Cervical and Lumbar) must align with safe and effective applications for intervertebral body fusion as defined by current medical standards and established for predicate devices. | IMPIX-C Cervical Interbody Device: Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7, used with autogenous bone graft and supplemental fixation after at least six weeks of non-operative treatment.IMPIX-L Lumbar Interbody Device: Indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, possibly with up to Grade I spondylolisthesis or retrolisthesis, used with autogenous bone graft and supplemental fixation after at least six months of non-operative treatment. |
| Material Composition | Material should be biocompatible and suitable for long-term implantation in the spine. | Both the IMPIX Cervical and Lumbar Interbody devices are machined from PEEK OPTIMA LT1. This material is widely accepted in spinal implants. An explicit performance metric is not stated beyond its use. |

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not applicable in the context of an AI/ML test set. The performance data refers to mechanical tests. The number of devices tested for mechanical strength is not specified.
Data Provenance: The mechanical tests were performed internally or by a testing laboratory according to the ASTM F2077 standard, which is an international standard for spinal implant testing. The country of origin of this specific test data is not mentioned, but the submitter is from France. The nature of these tests is prospective (performed for this submission) rather than retrospective clinical data.

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

This is not applicable as there is no "ground truth" to be established by clinical experts in the context of a mechanical performance study or substantial equivalence review. The "truth" for mechanical testing is adherence to the ASTM F2077 standard. The FDA reviewers are experts in regulatory compliance and medical device safety.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical "test set" requiring adjudication. Mechanical test results are objective measurements against a standard.

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

No. This device is not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant. The effectiveness is determined by its mechanical properties and long-term clinical outcomes (which are typically post-market surveillance for 510(k) devices, not pre-market studies).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical intervertebral body fusion device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission relies on:
- Mechanical Engineering Standards: Specifically, ASTM F2077 for intervertebral body fusion devices.
- Regulatory Precedent: The FDA's existing clearances for predicate devices, establishing what is considered safe and effective in terms of design, materials, and intended use.
- Material Science: The properties of PEEK OPTIMA LT1 as a biocompatible and structurally sound material for implantation.

8. Sample Size for the Training Set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

Summary

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K072226

510(k) SUMMARY

Page 1 of 2

GENERAL INFORMATION

DEC 1 0 2007

Trade Name	IMPIX Interbody Device
Common Name	intervertebral body fusion device
Classification Name	intervertebral body fusion device - cervicalintervertebral body fusion device - lumbar
Class	II
Product Code	ODPMAX
21 CFR section	888.3080
Device panel	Orthopedic
Legally marketed predicate devices	1. BAK/C Vista Interbody Fusion - peek-optima It1, Zimmer Spine, Inc (P980048 S003)2. BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025)3. LT-CAGE PEEK LUMBAR - peek-optima It1, Medtronic (P970015 S022)4. BAK INTERBODY LUMBAR FUSION - 65% peek optima/35% carbon fiber, Zimmer Spine (P950002 S011)
Submitter	MEDICREA™ TechnologiesZ.I. Chef de Baie17000 La Rochelle, France
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199

DEVICE DESCRIPTION

INTENDED USE

IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

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Page 2 of 2

IMPIX-L Lumbar Interbody Device 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.

PERFORMANCE DATA

Tests performed according to ASTM F2077 indicate that the IMPIX Interbody Fusion devices meet required mechanical strengths.

SUBSTANTIAL EQUIVALENCE

The IMPIX Interbody Fusion devices are similar in design, material, and intended use to its predicate devices that have been cleared by FDA for intervertebral body fusion.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol is a graphic representation of a human figure, with three lines forming the body and head, and a flowing cape-like element behind it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

DEC 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicrea Technologies % The Orthomedix Group, Inc. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K072226

Trade/Device Name: IMPIX Interbody Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: November 28, 2007 Received: December 3, 2007

Dear J.D. Webb:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K072226

Device Name: IMPIX Interbody Devices

Indications for Use:

IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

IMPIX-L Lumbar Interbody Device 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Narbare Buem

Division of General. Restorative. and Neurological Devices

510(k) Number_k072226

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.