(82 days)
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.
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
The provided text is a 510(k) premarket notification for a medical device, the Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology. It details the device's characteristics, indications for use, and a summary of pre-clinical performance data.
However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/human-in-the-loop system. The "Pre-Clinical Performance Data" section lists standard ASTM test methods for intervertebral body fusion devices, such as static and dynamic axial compression, static subsidence, and static expulsion/push-out. It also mentions evaluation for pyrogenicity using the Limulus Amebocyte Lysate (LAL) assay. These are mechanical and biological performance tests for the physical implant, not for an AI-driven or diagnostic system.
Therefore, I cannot populate the table or answer the specific questions related to AI system performance, ground truth, expert consensus, or MRMC studies, as this information is not present in the provided text. The document is for a physical medical implant, not an AI/software as a medical device (SaMD).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
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.
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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 CircleMarquette, MI 49855 USAContact: Diana TaylorPhone: (386) 418-8888Fax: (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 SystemReference Device: K163673, Fortilink®-C with TETRAfuse® 3D Technology |
| Description: | The interbody fusion (IBF) devices are designed to be inserted into theintervertebral body space of the spine, and are intended for intervertebral bodyfusion. These implants are manufactured from a radiolucent polymer(PolyEtherKetoneKetone (PEKK)) (ASTM F2820) which should supportradiographic imaging inside the implant to evaluate fusion status and areassembled with radiographic markers composed of tantalum (ASTM F560) tofacilitate proper implant position. The implants are provided sterile by gammairradiation and are intended to be used with supplemental fixation cleared for theimplanted level. The implants are supplied with instrumentation necessary tofacilitate the insertion and removal of the implants, as well as general manualsurgical instruments.These implants are provided in different footprints and varying heights to provideimplant 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-ClinicalPerformance Data: | The following Fortilink IBF System worst case construct pre-clinical performancedata 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 Subsidenceof an Intervertebral Body Fusion Device Under Static Axial Compression, forstatic subsidence.• DRAFT Z8423Z, Static Push-Out Test Method for Intervertebral Body FusionDevices, for static expulsion/push-out.Pyrogenicity of the sterile devices was evaluated using the Limulus AmebocyteLysate (LAL) assay. The devices are tested to ensure the endotoxin level meetsthe 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, thesedevices are indicated for use in skeletally mature patients with degenerative discdisease (DDD) of the cervical spine with accompanying radicular symptoms atone level or two contiguous levels. DDD is defined as discogenic pain withdegeneration of the disc confirmed by patient history and radiographic studies.These IBF devices are used to facilitate interbody fusion in the cervical spine andare placed via an anterior approach from C2-C3 to C7-T1 using autogenous bonegraft and/or allogenic bone graft comprised of cancellous and/or corticocancellousbone graft. The IBF devices are intended to be used with supplemental fixationcleared 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 inskeletally mature patients with degenerative disc disease (DDD) and up to Grade1 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 discconfirmed by history and radiographic studies. These IBF devices are used tofacilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 usingautogenous bone graft and/or allogenic bone graft comprised of cancellous and/orcorticocancellous bone graft to facilitate fusion. The IBF devices are intended tobe used with supplemental fixation cleared for the implanted level. Patients shouldhave at least six (6) months of non-operative treatment prior to treatment with aninterbody fusion device | |
| Conclusion | This submission supports that the subject Fortilink IBF devices are substantiallyequivalent to the previously cleared predicate devices. The subject and predicatedevices are equivalent in terms of indications for use, sterilization, packaging,technological characteristics, design features, and mechanical strength. There areno significant differences between the subject and predicate devices that wouldimpact the safety and effectiveness of the Fortilink IBF system. |
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§ 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.