(183 days)
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
This device is intended to treat degenerative disc disease and facilitate intervertebral body fusion, which are therapeutic applications.
No
The device description clearly states it is an implantable medical device used for intervertebral body fusion, not for diagnosing conditions. Its function is to provide structural support and facilitate bone growth, not to identify or assess a medical condition.
No
The device description clearly states it is a suite of "generally box shaped devices" manufactured from PEEK and containing radiographic markers, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to facilitate spinal fusion in patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant made of PEEK material, designed to be placed in the disc space. This is consistent with a surgical device, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical properties and safety of the implant (compression, expulsion, subsidence, bacterial testing), which are relevant to a surgical device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VertebraLINK Fusion Platform does not fit this description.
N/A
Intended Use / Indications for Use
The VertebraLINK Fusion Platform is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via posterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The VertebraLINK Fusion Platform is a comprehensive suite of generally box shaped devices which can be implanted into the prepared disc space when performing an intervertebral body fusion. The devices are manufactured from Invibio's PEEK Optima LT1 or PEEK Optima HA Enhanced per ASTM F2026. The devices contain a central axial opening for packing of bone graft material as well as teeth on the inferior and superior surfaces to resist expulsion. The platform will be offered in multiple lengths, widths, heights and lordoses to accommodate varying anatomies, pathologies, surgeon preferences, or techniques (i.e., TLIF, PLIF, or Oblique PLIF). Additionally, the device contains radiographic markers made from tantalum per ASTM F560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
Indicated Patient Age Range
skeletally mature
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
The following testing has been completed as part of the VertebraLINK Fusion Platform submission:
- Static axial compression per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Expulsion per ASTM Draft Standard F-04.25.02.02
- Subsidence per ASTM F2267
- Bacterial Amebocyte Lysate (LAL) testing per AAMI ST72
The results of this non-clinical testing show that the strength of the VertebraLINK Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2017
FacetLINK dba LINKSpine % Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K162693
Trade/Device Name: VertebraLINK Fusion Platform Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 3, 2017 Received: March 8, 2017
Dear Mr. Maxwell:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K162693 Page 1 of 1
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number (if known) | K162693 |
| Device Name | VertebraLINK Fusion Platform |
| Indications for Use (Describe) | The VertebraLINK Fusion Platform is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via posterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine. |
| Type of Use (Select one or both, as applicable) | 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) | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and |
the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (9/13)
3
510(K) SUMMARY
| Submitter's Name: | FacetLINK dba LINKSpine |
|---|---|
| Submitter's Address: | 101 Roundhill Drive |
| Rockaway, NJ 07866 | |
| Submitter's Telephone: | 973.627.4171 |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 23 March2016 |
| Trade or Proprietary Name: | VertebraLINK Fusion Platform |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 Device Classification |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The VertebraLINK Fusion Platform is a comprehensive suite of generally box shaped devices which can be implanted into the prepared disc space when performing an intervertebral body fusion. The devices are manufactured from Invibio's PEEK Optima LT1 or PEEK Optima HA Enhanced per ASTM F2026. The devices contain a central axial opening for packing of bone graft material as well as teeth on the inferior and superior surfaces to resist expulsion. The platform will be offered in multiple lengths, widths, heights and lordoses to accommodate varying anatomies, pathologies, surgeon preferences, or techniques (i.e., TLIF, PLIF, or Oblique PLIF). Additionally, the device contains radiographic markers made from tantalum per ASTM F560.
INDICATIONS FOR USE
The VertebraLINK Fusion Platform is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via posterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
4
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate Type |
|-------------|-------------------------------------------------|--------------------|----------------|
| K130573 | Interbody System | Tyber Medical | Primary |
| K112095 | AccuLiF® TL-PEEK Cage
and AccuLiF® TL and PL | CoAlign Innovation | Additional |
| K113478 | PLIF Cage | Eisertech | Additional |
| K151785 | Px HATM PEEK IBF
System | Innovasis | Reference |
Table 5-1: Predicate Devices
PERFORMANCE DATA
The following testing has been completed as part of the VertebraLINK Fusion Platform submission:
- . Static axial compression per ASTM F2077
- Dynamic axial compression per ASTM F2077 ●
- Expulsion per ASTM Draft Standard F-04.25.02.02 ●
- . Subsidence per ASTM F2267
- . Bacterial Amebocyte Lysate (LAL) testing per AAMI ST72
The results of this non-clinical testing show that the strength of the VertebraLINK Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
TECHNOLOGICAL CHARACTERISTICS
The following technological characteristics are similar between the VertebraLINK Fusion Platform and the predicate devices:
- Principles of Operation ●
- Indications for Use
- Materials ●
- Sterility ●
- Dimensional Features ●
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the VertebraLINK Fusion Platform is substantially equivalent to the predicate device.