(122 days)
P980048 S003, P960025, P970015 S022, P950002 S011
Not Found
No
The device description and intended use focus solely on the physical characteristics and function of an interbody fusion device made of PEEK material, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for intervertebral body fusion in patients with degenerative disc disease, which involves treating a medical condition.
No
Explanation: The device is an intervertebral body fusion device (IMPIX-C Cervical Interbody Device and IMPIX-L Lumbar Interbody Device) used for treatment by fusing vertebrae, not for diagnosis.
No
The device description clearly describes physical implants made of PEEK OPTIMA LT1, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the IMPIX devices are implants designed for surgical insertion into the spine to facilitate intervertebral body fusion. They are physical devices used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
Therefore, the IMPIX Cervical and Lumbar Interbody Devices are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
ODP, MAX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at one disc level from C3-C7, one or two contiguous levels from 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)
Tests performed according to ASTM F2077 indicate that the IMPIX Interbody Fusion devices meet required mechanical strengths.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P980048 S003, P960025, P970015 S022, P950002 S011
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.
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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 - cervical |
| intervertebral body fusion device - lumbar | |
| Class | II |
| Product Code | ODP |
| MAX | |
| 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) |
- BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025)
- LT-CAGE PEEK LUMBAR - peek-optima It1, Medtronic (P970015 S022)
- BAK INTERBODY LUMBAR FUSION - 65% peek optima/35% carbon fiber, Zimmer Spine (P950002 S011) |
| Submitter | MEDICREA™ Technologies
Z.I. Chef de Baie
17000 La Rochelle, France |
| Contact | J.D. Webb
1001 Oakwood Blvd
Round Rock, TX 78681
512-388-0199 |
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.
INTENDED USE
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.
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Page 2 of 2
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.
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 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 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.
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