(139 days)
P980048 S003, P960025
Not Found
No
The document describes a physical interbody fusion device made of PEEK, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated for degenerative disc disease to facilitate intervertebral body fusion and provides mechanical and biological functions to restore disc height, provide stability, and facilitate fusion.
No
This device is an implant designed to facilitate intervertebral body fusion; it is not used to diagnose a condition.
No
The device description clearly indicates that the device is a physical implant made of PEEK Optima®, designed for intervertebral body fusion. It is a hardware device, 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 devices 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 Foundation™ Cervical and Lumbar Interbody Devices are implants designed to be surgically placed in 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 testing of biological samples, analysis of bodily fluids, or diagnostic procedures performed on specimens.
Therefore, the Foundation™ Cervical and Lumbar Interbody Devices are medical devices, specifically implants, and do not fall under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Foundation Cervical implants are 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.
The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenc ne inn with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Fourdation™ Lumbar implants are to be used with autogenous bone graft and implanted via an open anterior or posterior approach. Foundation™ Lumbar implants are 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, ODP
Device Description
The interbody fusion with autogenous bone graft solves and provides a logical solution for discal diseases once the movement of the vertebral segment is eliminated. The theoretical principles of the interbody cages are based on the following foundations:
- Mechanical function, allows restoration of the intervertebral disc height and immediate 1. stability of the mobile segments.
- Biological function, related to the autogenous bone graft introduction into and around 2. the cage, facilitates the interbody fusion.
The posterior Foundation Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF).
The anterior Foundation Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Anterior Lumbar Interbody Fusion (ALIF),
The Foundation Cervical cage is a trapezoidal shape footprint for central placement in the vertebral body from an anterior approach.
Materials: PEEK Optima® conforming to ASTM F2026
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to C7 disc levels, lumbar spine, 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
Tests performed according to ASTM F2077 indicate that the Foundation Interbody Devices meet required mechanical strengths.
Key Metrics
Not Found
Predicate Device(s)
BAK/C Vista Interbody Fusion (P980048 S003), BRANTIGEN I/F CAGE (P960025)
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
510(k) Summary for the Foundation Interbody Devices
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Foundation Interbody Devices.
Date Prepared: February 4, 2008
-
- Submitter: Contact Person: Corelink LLC J.D. Webb 1547 Fencorp Dr. The OrthoMedix Group, Inc. Fenton, MO 62206 1001 Oakwood Blvd Round Rock, TX 78681
-
- Trade name: Foundation Interbody Devices Common Name: intervertebral body fusion device Classification Name: intervertebral body fusion device - cervical intervertebral body fusion device - lumbar 21 CFR 888.3080 Class II ODP MAX
-
- Predicate or legally marketed devices which are substantially equivalent: BAK/C Vista Interbody Fusion (P980048 S003) BRANTIGEN I/F CAGE (P960025)
4. Description of the device:
The interbody fusion with autogenous bone graft solves and provides a logical solution for discal diseases once the movement of the vertebral segment is eliminated. The theoretical principles of the interbody cages are based on the following foundations:
-
Mechanical function, allows restoration of the intervertebral disc height and immediate 1. stability of the mobile segments.
Telephone: 512-388-0199 -
Biological function, related to the autogenous bone graft introduction into and around 2. the cage, facilitates the interbody fusion.
The posterior Foundation Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF).
The anterior Foundation Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Anterior Lumbar Interbody Fusion (ALIF),
The Foundation Cervical cage is a trapezoidal shape footprint for central placement in the vertebral body from an anterior approach.
Materials:
PEEK Optima® conforming to ASTM F2026
5. Intended Use:
Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Foundation Cervical implants are to be used with
iv
APR 2 4 2008
1
Image /page/1/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K073440". The characters are written in a simple, clear style, with consistent stroke thickness. The background is plain white.
supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenc ne inn with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Fourdation™ Lumbar implants are to be used with autogenous bone graft and implanted via an open anterior or posterior approach. Foundation™ Lumbar implants are 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.
Comparison of the technological characteristics of the device to predicate and legally marketed 6. devices:
The Foundation Interbody Devices are similar in design, material, and intended use to their predicate devices that have been cleared by FDA for intervertebral body fusion.
7. Summary of Nonclincal Tests
Tests performed according to ASTM F2077 indicate that the Foundation Interbody Devices meet required mechanical strengths.
pg 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, TX 78681
APR 2 4 2008
Re: K073440
Trade/Device Name: Foundation™ Interbody Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: April 9, 2008 Received: April 21, 2008
Dear Mr. 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.
3
Page 2 - Mr. 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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millikan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073490
Device Name: Foundation™ Interbody Devices
Indications for Use:
Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Foundation Cervical implants are 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.
The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants are to be used with autogenous bone graft and implanted via an open anterior or posterior approach..Foundation™ Lumbar implants are 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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Gyl for nan
and Neurological Devices
510(k) Number K073440
$$\pi$$
1 of 1