(147 days)
No
The summary describes a physical medical device (interbody fusion device/vertebral body replacement) made of PEKK material with specific design features and mechanical testing results. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven analysis component.
Yes.
The device is used to facilitate interbody fusion, restore spinal height, and treat fractures, which are all therapeutic interventions for medical conditions.
No
The device is described as an interbody fusion device and vertebral body replacement device, used to facilitate fusion and restore height and biomechanical integrity. It is an implantable medical device, not a diagnostic tool.
No
The device description clearly states that the Fortilink-C IBF/VBR implants are manufactured from PEKK material and include radiographic marker pins from tantalum, indicating a physical hardware device.
Based on the provided information, 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 or replace vertebral bodies. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant made of PEKK with radiographic markers. It is designed to be surgically placed within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or provide information about a patient's health status based on in vitro analysis.
- Performance Studies: The performance studies focus on mechanical strength and biocompatibility, which are relevant for surgical implants, not diagnostic devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Fortilink-C device does not fit this description.
N/A
Intended Use / Indications for Use
The Fortilink-C interbody fusion devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Fortilink-C devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc to the C7-T1 disc using autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Fortilink-C devices are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.
When used as a vertebral body replacement (VBR) device, Fortilink-C devices are for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. V BRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with autogenous or allogenic bone graft and must be used with supplemental internal fixation systems.
Product codes
ODP, MQP
Device Description
The Fortilink-C IBF/VBR implants are manufactured from radiolucent polyetherketoneketone (PEKK) material (ASTM F2820) in various footprints and sizes. Each implant includes radiographic marker pins from tantalum (ASTM F560) and a central graft containment window. Each implant has insertion slot features on the anterior face to mate with an insertion instrument. The Fortilink-C IBF/VBR implants includes both 0° (parallel) and 6° lordosis, and designs with and without teeth. Class II accessories and Class I (exempt) manual surgical instruments are available for use with the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, thoracolumbar spine (TI-L5)
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)
For a determination of substantial equivalence, static and dynamic axial compression and torsion testing was submitted in accordance with ASTM F2077. In addition, static subsidence testing per ASTM F2267 and static expulsion testing per Draft Standard Z8423Z (ASTM F-04.25.02.02) were performed. Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to the legally marketed predicate devices and sufficient for the intended use. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
RTI Surgical, Inc. Diana Taylor Senior Regulatory Affairs Specialist 11621 Research Circle Alachua, Florida 32615
May 23, 2017
Re: K163673
Trade/Device Name: Fortilink™-C with TETRAfuse™ 3D Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: April 21, 2017 Received: April 24, 2017
Dear Ms. Taylor:
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
1
related adverse events) (21 CFR 803); 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.
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
Indications for Use
510(k) Number (if known) K163673
Device Name
Fortilink™-C with TETRAfuse™ 3D Technology
Indications for Use (Describe)
The Fortilink-C interbody fusion devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Fortilink-C devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc to the C7-T1 disc using autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Fortilink-C devices are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.
When used as a vertebral body replacement (VBR) device, Fortilink-C devices are for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. V BRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with autogenous or allogenic bone graft and must be used with supplemental internal fixation systems.
| 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) |
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3
Image /page/3/Picture/1 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in white on a blue rounded square, followed by the word "surgical" in gray. The logo is simple and modern, and it is likely used to identify the company and its products.
510(k) Summary Pursuant to 21 CFR 807.92
| Sponsor: | Pioneer Surgical Technology, Inc.
(DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette, MI 49855 USA
Contact: Diana Taylor
Phone: (386) 418-8888
Fax: (386) 418-1627
Prepared: May 22, 2017 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name: | Cervical Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) |
| Trade names: | FortilinkTM-C with TETRAfuseTM 3D Technology |
| Common name: | Intervertebral Body Fusion / Vertebral Body Replacement Implants |
| Classifications: | 21 CFR 888.3080 and 21 CFR 888.3060 – Class II |
| Product Codes: | ODP (Intervertebral fusion device (IBF) with bone graft, cervical)
MQP (spinal vertebral body replacement device (VBR)) |
| Panel/ Branch: | Orthopedic and Rehabilitation Devices Panel; Panel Code 87
Anterior Spinal Devices Branch |
| Predicates: | • Primary Predicate: K133623, C-Plus IBF/VBR,
Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc.
• Additional Predicate: K142005, SpineFab® VBR
Oxford Performance Materials, Inc., |
| Description: | The Fortilink-C IBF/VBR implants are manufactured from radiolucent
polyetherketoneketone (PEKK) material (ASTM F2820) in various footprints
and sizes. Each implant includes radiographic marker pins from tantalum
(ASTM F560) and a central graft containment window. Each implant has
insertion slot features on the anterior face to mate with an insertion
instrument. The Fortilink-C IBF/VBR implants includes both 0° (parallel)
and 6° lordosis, and designs with and without teeth. Class II accessories and
Class I (exempt) manual surgical instruments are available for use with the
implants. |
| Non-Clinical
Testing: | For a determination of substantial equivalence, static and dynamic axial
compression and torsion testing was submitted in accordance with ASTM
F2077. In addition, static subsidence testing per ASTM F2267 and static
expulsion testing per Draft Standard Z8423Z (ASTM F-04.25.02.02) were
performed. Mechanical testing showed that the mechanical strength of the
subject system is substantially equivalent to the legally marketed predicate
devices and sufficient for the intended use.
Bacterial endotoxin testing (BET) was conducted in accordance with
ANSI/AAMI ST-72. |
| Indication for
Use: | The Fortilink-C interbody fusion devices are indicated for use in skeletally
mature patients with degenerative disc disease (DDD) of the cervical spine
with accompanying radicular symptoms at one level or two contiguous levels.
DDD is defined as discogenic pain with degeneration of the disc confirmed by
patient history and radiographic studies. The Fortilink-C devices are used to
facilitate interbody fusion in the cervical spine and are placed via an anterior
approach from the C2-C3 disc to the C7-T1 disc using autogenous or
allogenic bone graft comprised of cancellous and/or corticocancellous bone
graft. The Fortilink-C devices are to be used with supplemental fixation.
Patients should have at least six (6) weeks of non-operative treatment prior to
treatment with an interbody fusion device.
When used as a vertebral body replacement (VBR) device, Fortilink-C
devices are for use in the thoracolumbar spine (TI-L5) for partial replacement
(i.e., partial vertebrectomy) of a diseased vertebral body resected or excised
for the treatment of tumors in order to achieve anterior decompression of the
spinal cord and neural tissues, and to restore the height of a collapsed
vertebral body. VBRs are also indicated for treating fractures of the thoracic
and lumbar spine. VBRs are designed to restore the biomechanical integrity of
the anterior, middle and posterior spinal column, even in the absence of fusion
for a prolonged period of time. The VBR device is intended to be used with
autogenous or allogenic bone graft and must be used with supplemental
internal fixation systems. |
| Conclusion: | This submission supports the position that the subject implants are
substantially equivalent to previously cleared predicate devices.
The subject and predicate devices are similar in terms of indications for use,
material composition, sterilization, packaging, technological characteristics,
design features, and mechanical strength.
There are no significant differences between the subject and predicate devices
that would affect the safety and effectiveness of the Fortilink-C system. Any
differences were not considered significant based on mechanical performance,
bench testing. |
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Image /page/4/Picture/0 description: The image shows the logo for "rti surgical". The logo consists of the letters "rti" in a blue rounded square with a small green leaf on the top right corner of the "i". To the right of the square is the word "surgical" in gray.