(169 days)
Not Found
No
The 510(k) summary describes a physical intervertebral body fusion device and its associated components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on mechanical testing of the implant.
Yes.
The device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
This device is an intervertebral body fusion device (implant) designed to aid in spinal fusion. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a lumbar Intervertebral Body Fusion Device made from HAPEEK incorporating titanium bone screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The T-Rex Intervertebral Body Fusion Device is a surgical implant used to fuse vertebrae in the lumbar spine. It is a physical device implanted into the body, not a device used to analyze samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples. The "Radiographic studies" mentioned are used for pre-operative planning and post-operative assessment, not for in vitro diagnostic testing.
Therefore, the T-Rex Intervertebral Body Fusion Device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used with the bone screws, the T-Rex Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the interior of the interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/ or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The T-Rex™ Standalone ALIF is a lumbar Intervertebral Body Fusion Device with integrated fixation made from HA Enhanced PEEK-OPTIMA (HAPEEK) incorporating titanium bone screws. The implants are available in various heights, widths, lengths, and angles of lordosis to accommodate patients' anatomy. The implants are provided sterile with surgical instruments provided non-sterile to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), are included in each implant to allow radiographic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
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)
No FDA performance standards have been established for the T-Rex Standalone ALF. The following tests were performed in order to demonstrate safety based on current industry standards:
- Static and dynamic compression and compression shear (per ASTM F2077)
- Subsidence (per ASTM F2267)
- Expulsion
- Push out test on the screws
The results of these tests indicate that the T-Rex Standalone ALIF is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K141942, K151785, K162351, K170511
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
September 7, 2017
SIATS, LLC % Allison C. Komivama. Ph.D., R.A.C. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn Street San Diego, California 92104
Re: K170855
Trade/Device Name: T-Rex Standalone ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: July 25, 2017 Received: July 26, 2017
Dear Dr. Komiyama:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (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. 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.
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name T-Rex Standalone ALIF
Indications for Use (Describe)
When used with the bone screws, the T-Rex Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the interior of the interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/ or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K170855
DATE PREPARED
July 25, 2017
MANUFACTURER AND 510(k) OWNER
SIATS, LLC 6316 E 102™ Street, Tulsa, OK 74137, USA Telephone: Official Contact: Robert Compton, CEO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
T-Rex Standalone ALIF
COMMON NAME
Intervertebral Fusion Device with Integrated Fixation, Lumbar
DEVICE CLASSIFICATION
Intervertebral body fusion device (21 CFR 888.3080, Product Code OVD Class II)
PREMARKET REVIEW
ODE/DOD/ASDB Orthopedic Panel
INDICATIONS FOR USE
When used with the bone screws, the T-Rex Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
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DEVICE DESCRIPTION
The T-Rex™ Standalone ALIF is a lumbar Intervertebral Body Fusion Device with integrated fixation made from HA Enhanced PEEK-OPTIMA (HAPEEK) incorporating titanium bone screws. The implants are available in various heights, widths, lengths, and angles of lordosis to accommodate patients' anatomy. The implants are provided sterile with surgical instruments provided non-sterile to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), are included in each implant to allow radiographic visualization.
PREDICATE DEVICE IDENTIFICATION
The T-Rex Standalone ALIF is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K141942 | Midline II / Midline II / Centinel Spine Inc. | ✓ |
| K151785 | Px HA PEEK IBF System / Innovasis, Inc. | |
| K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® / | |
| SeaSpine Orthopedics Corp. | ||
| K170511 | NeoFuse HA Enhanced PLIF/TLIF / HT Medical, LLC |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the T-Rex Standalone ALF. The following tests were performed in order to demonstrate safety based on current industry standards:
- . Static and dynamic compression and compression shear (per ASTM F2077)
- Subsidence (per ASTM F2267) .
- . Expulsion
- o Push out test on the screws
The results of these tests indicate that the T-Rex Standalone ALIF is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
SIATS, LLC believes that the T-Rex Standalone ALIF is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has similar dimensions, similar materials and the same indications for use as the devices cleared in K141942 and K162351. It uses the same materials as the device cleared in K151785 and similar manufacturing processes as the device cleared in K170511. The subject device has a similar design and similar technological characteristics to the devices cleared in K141942 and K162351.
CONCLUSION
The T-Rex Standalone ALIF is considered substantially equivalent to the predicate devices based on the testing performed, the similar indications for use, and equivalent technological characteristics. Based on the testing performed, it can be concluded that the subject device is as safe and as effective compared to the predicate devices.