(135 days)
Not Found
No
The 510(k) summary describes a physical interbody fusion device and does not mention any software, algorithms, or AI/ML capabilities. The changes described are related to physical dimensions and surgical approaches.
Yes
The device is an implant designed to facilitate intervertebral body fusion and is used in patients with degenerative disc disease, aiming to alleviate pain and restore function, which are therapeutic goals.
No
Explanation: The provided text describes intervertebral body fusion devices (implants) used for treatment, not for diagnosing conditions. Their purpose is to facilitate fusion by replacing bone graft blocks and providing support for bone growth.
No
The device description clearly states it is an "implant" and describes physical characteristics and materials, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Foundation™ Interbody Devices are implants developed for the substitution of bone graft blocks in spinal fusion procedures. They are physically placed within the patient's body.
- Intended Use: The intended use describes a surgical procedure to facilitate intervertebral body fusion in the spine. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
Therefore, the Foundation™ Interbody Devices are medical devices used in surgical procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Foundation™ Interbody Devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the graft donation site. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).
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 one disc level (C2-T1) 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 supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The Foundation™ Interbody Devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the graft donation site. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).
The changes to the Foundation™ Interbody Devices cleared in K0733440 and included in this Special 510(k) are:
• Removal of specific surgical approaches for the lumbar devices
• Addition of additional sizes and configurations
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1), 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Summary: The following analyses were conducted: Finite Element Analysis Bone graft area in contact with endplates and graft volume Cross sectional area The results of these evaluations indicate that the Foundation™ Interbody Devices are equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K073440, K081614, K081917, K094025, K133216, K073144, K090064, K130573
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a way that suggests unity and connection. The profiles are black and are set against a white background. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
CoreLink, LLC % Mr. J.D. Webb Official Correspondent The Orthomedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K150847
Trade/Device Name: Foundation™ Interbody Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: June 22, 2015 Received: July 27, 2015
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. J.D. Webb
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name
Foundation™ Interbody Devices
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical some with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by pairent history and radies. Foundation™ Cervical implants are used to facilitate interverebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) 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 supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Summary: Foundation™ Interbody Devices
| Date Prepared | March 26, 2015 |
|---|---|
| Submitted By | Corelink, LLC |
| 7606 Forsyth Blvd | |
| Clayton, MO 63105 | |
| 888-349-7808 Tele | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Foundation™ Interbody Devices |
| Common Name | intervertebral body fusion device |
| Classification Name | intervertebral body fusion device - cervical |
| intervertebral body fusion device - lumbar | |
| Class | II |
| Product Code | ODP |
| MAX | |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Foundation™ Interbody Devices - K073440 |
| Secondary Predicate | |
| Devices | Amendia (Verticor) Zeus Cage - K081614 |
| DePuy Bengal - K081917 | |
| Medtronic Verte-Stack Crescent - K094025, K133216 | |
| Lanx Timberline - K073144 | |
| Eminent Spine Cottonmouth - K090064 | |
| Tyber Medical PLIF - K130573 | |
| Device Description | The Foundation™ Interbody Devices are implants developed for the substitution |
| of the classical autogenous bone graft blocks. The cages assist to avoid | |
| complications related to the graft donation site. They are available in a range of | |
| footprints and heights to suit the individual pathology and anatomical conditions | |
| of the patient. The implants have a hollow center to allow placement of | |
| autogenous bone graft. The superior and inferior surfaces are open to promote | |
| contact of the bone graft with the vertebral end plates, allowing bone growth | |
| (arthrodesis). | |
| The changes to the Foundation™ Interbody Devices cleared in K0733440 and | |
| included in this Special 510(k) are: | |
| • Removal of specific surgical approaches for the lumbar devices | |
| • Addition of additional sizes and configurations |
4
| Materials | Invibio® PEEK Optima LT1 (ASTM F2026)
Tantalum (ASTM F560). |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence Claimed
to Predicate Devices | The Foundation™ Interbody Devices are substantially equivalent to the predicate
devices in terms of intended use, design, materials used, mechanical safety and
performances. |
| 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 one disc level (C2-T1) 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 supplemental fixation.
Patients should have at least six (6) months of non-operative treatment prior to
treatment with an intervertebral cage. |
| Non-clinical Test
Summary | The following analyses were conducted:
Finite Element Analysis Bone graft area in contact with endplates and graft volume Cross sectional area The results of these evaluations indicate that the Foundation™ Interbody Devices
are equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-
clinical and Clinical | Corelink, LLC considers the Foundation™ Interbody Devices to be equivalent to
the predicate devices listed above. This conclusion is based upon the devices'
similarities in principles of operation, technology, materials and indications for
use |