(82 days)
No
The summary describes a physical interbody fusion device made of PEKK with tantalum markers. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven functionality. The performance studies are mechanical and biological tests, not related to AI/ML performance.
Yes
The device is an interbody fusion (IBF) implant intended to facilitate spinal fusion in patients with degenerative disc disease, which is a therapeutic purpose.
No
Explanation: The device described is an interbody fusion (IBF) implant, indicated for facilitating spinal fusion in patients with degenerative disc disease. Its purpose is therapeutic, to physically fuse vertebrae, not to diagnose a condition. While it allows for radiographic imaging to evaluate fusion status, the device itself does not perform diagnostic functions.
No
The device description clearly states it is an implant manufactured from a radiolucent polymer and assembled with radiographic markers, which are physical components, not software. The performance studies also focus on mechanical testing of the physical implant.
Based on the provided text, 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 interbody fusion in the spine. It is a physical device implanted into the body.
- Device Description: The device description details the materials, design, and function of a spinal implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
When Fortilink-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative 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. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.
When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in sketally mature patients with degenerative disc disease (DD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an interbody fusion device.
Product codes
MAX, ODP
Device Description
The interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine, and are intended for intervertebral body fusion. These implants are manufactured from a radiolucent polymer (PolyEtherKetoneKetone (PEKK)) (ASTM F2820) which should support radiographic imaging inside the implant to evaluate fusion status and are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant position. The implants are provided sterile by gamma irradiation and are intended to be used with supplemental fixation cleared for the implanted level. The implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments.
These implants are provided in different footprints and varying heights to provide implant options best suited to an individual's pathology and anatomical condition. The following designs are included in the Fortilink IBF System :
- Fortilink-C IBF System
- Fortilink-TS IBF System
- Fortilink-L IBF System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C3 to C7-T1), Lumbar spine (L1-L2 to L5-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)
The following Fortilink IBF System worst case construct pre-clinical performance data supports the determination of substantial equivalence:
• ASTM F2077, Test Methods for Intervertebral Body Fusion Devices, for static and dynamic axial compression and static and dynamic torsion.
• ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression, for static subsidence.
• DRAFT Z8423Z, Static Push-Out Test Method for Intervertebral Body Fusion Devices, for static expulsion/push-out.
Pyrogenicity of the sterile devices was evaluated using the Limulus Amebocyte Lysate (LAL) assay. The devices are tested to ensure the endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
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.
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October 23, 2017
RTI Surgical, Inc. Diana Taylor Sr. Regulatory Specialist 375 River Park Circle Marquette, MI 49855
Re: K172343
Trade/Device Name: Fortilink@ Interbody Fusion (IBF) System with TETRAfuse® 3D Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: September 28, 2017 Received: September 29, 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172343
Device Name
Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
Indications for Use (Describe)
When Fortilink-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative 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. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.
When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in sketally mature patients with degenerative disc disease (DD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an interbody fusion device.
| 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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Image /page/3/Picture/1 description: The image shows the logo for RTI Surgical. The logo consists of the letters 'rti' in a blue rounded square, followed by the word 'surgical' in gray. The 'i' in 'rti' has a small green dot above it.
510(k) Summary Pursuant to 21 CFR 807.92
| Sponsor: | RTI Surgical, Inc.
375 River Park Circle
Marquette, MI 49855 USA
Contact: Diana Taylor
Phone: (386) 418-8888
Fax: (386) 418-1627 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Prepared: October 20, 2017 |
| Trade name: | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology |
| Common name: | Intervertebral Body Fusion Implants |
| Regulation: | 21 CFR 888.3080; Class II |
| Product Codes | MAX and ODP |
| Device Panel: | Orthopedic |
| Predicate Devices: | Primary Predicate Device: K170643 PEEK IBF/VBR System
Reference Device: K163673, Fortilink®-C with TETRAfuse® 3D Technology |
| Description: | The interbody fusion (IBF) devices are designed to be inserted into the
intervertebral body space of the spine, and are intended for intervertebral body
fusion. These implants are manufactured from a radiolucent polymer
(PolyEtherKetoneKetone (PEKK)) (ASTM F2820) which should support
radiographic imaging inside the implant to evaluate fusion status and are
assembled with radiographic markers composed of tantalum (ASTM F560) to
facilitate proper implant position. The implants are provided sterile by gamma
irradiation and are intended to be used with supplemental fixation cleared for the
implanted level. The implants are supplied with instrumentation necessary to
facilitate the insertion and removal of the implants, as well as general manual
surgical instruments.
These implants are provided in different footprints and varying heights to provide
implant options best suited to an individual's pathology and anatomical condition.
The following designs are included in the Fortilink IBF System :
- Fortilink-C IBF System
- Fortilink-TS IBF System
- Fortilink-L IBF System |
| Pre-Clinical
Performance Data: | The following Fortilink IBF System worst case construct pre-clinical performance
data supports the determination of substantial equivalence:
• ASTM F2077, Test Methods for Intervertebral Body Fusion Devices,
for static and dynamic axial compression and static and dynamic torsion.
• ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence
of an Intervertebral Body Fusion Device Under Static Axial Compression, for
static subsidence.
• DRAFT Z8423Z, Static Push-Out Test Method for Intervertebral Body Fusion
Devices, for static expulsion/push-out.
Pyrogenicity of the sterile devices was evaluated using the Limulus Amebocyte
Lysate (LAL) assay. The devices are tested to ensure the endotoxin level meets
the requirements of maximum endotoxin limit for implantable medical devices
[20 EU per device]. |
| Indication for Use: | When Fortilink-C is used as cervical interbody fusion (IBF) implants, these
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.
These IBF devices are used to facilitate interbody fusion in the cervical spine and
are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone
graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous
bone graft. The IBF devices are intended to be used with supplemental fixation
cleared for the implanted level. Patients should have at least six (6) weeks of non-
operative treatment prior to treatment with an interbody fusion device.
|
| | When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF)
implants, these devices are indicated for intervertebral body fusion of the spine in
skeletally mature patients with degenerative disc disease (DDD) and up to Grade
1 spondylolisthesis of the lumbar spine at one level or two contiguous levels.
DDD is defined as back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies. These IBF devices are used to
facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using
autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft to facilitate fusion. The IBF devices are intended to
be used with supplemental fixation cleared for the implanted level. Patients should
have at least six (6) months of non-operative treatment prior to treatment with an
interbody fusion device |
| Conclusion | This submission supports that the subject Fortilink IBF devices are substantially
equivalent to the previously cleared predicate devices. The subject and predicate
devices are equivalent in terms of indications for use, sterilization, packaging,
technological characteristics, design features, and mechanical strength. There are
no significant differences between the subject and predicate devices that would
impact the safety and effectiveness of the Fortilink IBF system. |
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