(114 days)
Not Found
No
The summary describes a physical interbody fusion device and its mechanical properties, with no mention of software, algorithms, or any AI/ML related terms.
Yes
This device is a therapeutic device because its intended use is to facilitate intervertebral body fusion in patients with degenerative disc disease, which is a treatment for a medical condition.
No
Explanation: The device is an interbody fusion device intended for treatment, specifically for spinal fusion in patients with degenerative disc disease. It is a therapy device, not a diagnostic one.
No
The device description explicitly states it is an "Interbody Fusion Device" made from PEEK or titanium alloy, which are physical materials. It also describes physical features like a hollow chamber and teeth, and mentions performance testing related to mechanical properties (compression, shear, expulsion, subsidence). This indicates a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The LEGEND Spine STYLO Interbody Fusion Device is an implantable medical device designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a physical device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the LEGEND Spine STYLO Interbody Fusion Device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LEGEND Spine STYLO Interbody Fusion Device is 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). LEGEND Spine STYLO Interbody Fusion Device is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
LEGEND Spine STYLO Interbody Fusion Device implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes
MAX
Device Description
The Legend Spine Technologies STYLO Interbody Fusion Device is an Interbody Fusion Device that has a hollow chamber to permit packing with autologous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine Technologies STYLO interbody implants are made from either PEEK radiolucent material with embedded tantalum x-ray markers (ASTM F2026 and ASTM F560) or titanium alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L2-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Static and dynamic axial compression, static and dynamic compression shear, expulsion, and subsidence testing were completed for the STYLO Interbody Fusion Device according to ASTM F2077-14, ASTM F2267-04, and the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007. Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
May 3, 2018
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services-USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
Legend Spine Technologies Christine Scifert Exec. VP MRC/X, LLC 6075 Poplar Avenue Memphis, Tennessee 38119
Re: K180071
Trade/Device Name: STYLO Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 2, 2018 Received: April 3, 2018
Dear Ms. Scifert:
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
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for 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) K180071
Device Name STYLO Interbody Fusion Device
Indications for Use (Describe)
The LEGEND Spine STYLO Interbody Fusion Device is 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). LEGEND Spine STYLO Interbody Fusion Device is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
LEGEND Spine STYLO Interbody Fusion Device implants are to be used with 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)
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3
510(k) Summary
STYLO Interbody Fusion Device April 27, 2018
| Company: | Legend Spine Technologies
1803 Apple Tree Lane
Bethlehem, PA 18015 |
|----------------------|--------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert
Phone: 901-831-8053 |
| Company Contact: | Gwendolyn DeBoer
Phone: 610-366-0077
contact@legendspine.net |
| Trade Name: | STYLO Interbody Fusion Device |
| Common Name: | Intervertebral Fusion Device with Bone Graft Lumbar |
| Classification: | II |
| Classification Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 888.3080 |
| Panel: | 87-Orthopedic |
| Product Code(s): | MAX |
Device Description: The Legend Spine Technologies STYLO Interbody Fusion Device is an Interbody Fusion Device that has a hollow chamber to permit packing with autologous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine Technologies STYLO interbody implants are made from either PEEK radiolucent material with embedded tantalum x-ray markers (ASTM F2026 and ASTM F560) or titanium alloy conforming to ASTM F136.
Indications for Use: The LEGEND Spine STYLO Interbody Fusion Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DD) 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). LEGEND Spine STYLO
4
Interbody Fusion Device is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
LEGEND Spine STYLO Interbody Fusion Device implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate:
-
Medtronic CAPSTONE® CONTROL Spinal System (K171107) .
Secondary Predicates: -
Medtronic CAPSTONE® PEEK Spinal System (K133650)
-
Camber Spine Technologies, TLS 5.0 Interbody Cage (K121254) .
The subject STYLO Interbody Fusion Device is made from PEEK/Tantalum and Titanium Alloy have demonstrated to be substantially equivalent to the previously cleared devices cleared under K171107. K133650, and K121254 as the products are similar in indications, materials and geometry.
Performance Testing: Static and dynamic axial compression, static and dynamic compression shear, expulsion, and subsidence testing were completed for the STYLO Interbody Fusion Device according to ASTM F2077-14, ASTM F2267-04, and the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007. Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.