(147 days)
Not Found
No
The summary describes a passive intervertebral body fusion device made of PEEK, with no mention of software, algorithms, or any computational capabilities that would suggest the use of AI or ML.
Yes
The device is described as an "intervertebral body fusion device" used to facilitate fusion in the lumbar spine for patients with degenerative disc disease. Its purpose is to treat a medical condition and restore function, hence it is a therapeutic device.
No
The device is an intervertebral body fusion device (cage) used to facilitate spinal fusion in patients with degenerative disc disease, not to diagnose a medical condition.
No
The device description explicitly states the device is a "rectangular cage geometry" manufactured from PEEK, which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Signature Orthopaedics Arlington PLIF/TLIF system is an implantable medical device used in surgery to facilitate fusion in the lumbar spine. It is a physical cage made of PEEK material that is inserted into the disc space.
- Lack of Diagnostic Activity: The description and intended use clearly state that the device is used for treatment (spinal fusion) and not for diagnosing a condition by analyzing a sample from the body.
Therefore, the Arlington PLIF/TLIF system falls under the category of a surgical implant or medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Signature Orthopaedics Arlington PLIF/TLIF system is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLIF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.
Product codes
MAX
Device Description
The Signature Orthopaedics Arlington PLIF/TLIF cages are manufactured from PEEK OPTIMA LT1 per ASTM-F2026.
The Arlington PLIF/TLIF cage is intended for implantation by a posterior or transforminal approach. The device consists of a rectangular cage geometry with a bulleted tip to ease insertion and serrated teeth on the inferior and superior surfaces to resist expulsion from the disc space. The center of the cage is hollow to allow loading of bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
lumbar spine (L2-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
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Arlington PLIF/TLIF is adequate for anticipated in-vivo use. Nonclinical testings carried out on the Intervertebral Fusion Devices mentioned above were:
- Static and dynamic axial compression and compression shear testing
- Subsidence testing
Standard Used for Performance Testing:
- ASTM-F2077 Test Method for Intervertebral Body Fusion Devices
- ASTM-F2267 Standard Teest Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Non-clinical testing results support the substantial equivalence decision. The subject devices are expected to perform adequately during clinical use.
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.
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Image /page/0/Picture/0 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.
Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, AU 2066 NSW
November 29, 2017
Re: K172020
Trade/Device Name: Arlington PLIF/TLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 27, 2017 Received: October 30, 2017
Dear Dr. Brazil:
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 (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 mediation-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,
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) K172020
Device Name Arlington PLIF/TLIF Cage
Indications for Use (Describe)
The Signature Orthopaedics Arlington PLIF/TLIF system is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.
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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2 510(K) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Arlington PLIF/TLIF Cage |
| Common Name: | Lumbar Intervertebral Fusion Device |
| Contact: | Dr. Declan Brazil
Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia
Phone: +61 (2) 9428 5181
Fax: +61 (2) 8456 6065 |
| Date Prepared: | June 29th, 2017 |
| Classification: | Class II per 21 CFR 888.3080: Intervertebral Body Fusion
Device (MAX) |
| Predicate Devices: | ● Primary Predicate:
● DePuy Concorde Curve (K101923)
● Additional Predicates:
● Spineart DYNAMIK Lumbar Interbody Device (K081888)
● DePuy Lumbar I/F (P960025). |
Device Description:
The Signature Orthopaedics Arlington PLIF/TLIF cages are manufactured from PEEK OPTIMA LT1 per ASTM-F2026.
The Arlington PLIF/TLIF cage is intended for implantation by a posterior or transforminal approach. The device consists of a rectangular cage geometry with a bulleted tip to ease insertion and serrated teeth on the inferior and superior surfaces to resist expulsion from the disc space. The center of the cage is hollow to allow loading of bone graft.
Indications for Use:
The Signature Orthopaedics Arlington PLIF/TLIF system is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar
4
spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLIF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.
Performance Testing:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Arlington PLIF/TLIF is adequate for anticipated in-vivo use. Nonclinical testings carried out on the Intervertebral Fusion Devices mentioned above were:
- . Static and dynamic axial compression and compression shear testing
- Subsidence testing ●
Standard Used for Performance Testing
- ASTM-F2077 Test Method for Intervertebral Body Fusion Devices
- . ASTM-F2267 Standard Teest Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Substantial Equivalence:
The Arlington PLIF/TLIF cage has the same intended use, indications for use, materials and similar design as the DePuy Concorde Curve (K101923), Spineart DYNAMIK Lumbar Interbody Device (K081888) and DePuy Lumbar I/F (P960025). Non-clinical testing results support the substantial equivalence decision. The subject devices are expected to perform adequately during clinical use.
Conclusion:
Technical comparison of the subject and predicate devices demonstrates substantial equivalence in device design, intended use, indications for use and material. Non-clinical data support the substantial equivalence of the device.