(235 days)
Not Found
No
The summary describes a passive implant and surgical instruments, with no mention of AI or ML capabilities.
Yes
The device is used to facilitate fusion in the lumbar spine for patients with degenerative disc disease, which confirms its therapeutic purpose.
No
The device is an intervertebral body fusion device used to facilitate fusion in the lumbar spine, not to diagnose a condition.
No
The device description clearly states it is a 3D printed implant and includes associated instrumentation, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Innovasis TxTi Transforaminal Lumbar IBF System is an implantable device designed to be surgically placed in the lumbar spine to facilitate fusion. It is a physical device used within the body, not a tool for analyzing samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure to treat degenerative disc disease by implanting a device. It does not involve testing biological samples.
Therefore, the Innovasis TxTi Transforaminal Lumbar IBF System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Innovasis TxTi Transforaminal Lumbar IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Innovasis TxTi IBF System is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implants are 3D printed.
The single use implant devices feature a honeycomb structure with an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration surface to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support TLIF surgeries are provided with the implants in custom sterilization trays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2-S1)
Indicated Patient Age Range
Skeletally mature
Intended User / Care Setting
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
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)
Performance testing per ASTM F2077-17 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, Subsidence and Expulsion testing indicates that the TxTi IBF is substantially equivalent to the predicates.
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.
K180078 Innovasis TxHA® PEEK IBF System, K162496 CoreLink Foundation™ 3D Interbody
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
June 28, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Innovasis, Inc. Marshall McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K183064
Trade/Device Name: TxTiTM IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 24, 2019 Received: May 28, 2019
Dear Mr. McCarty:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K183064
Device Name TxTi™ IBF System
Indications for Use (Describe)
The Innovasis TxTi Transforaminal Lumbar IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.
| 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 Innovasis. The logo is in black and white and features the word "INNOVASIS" in a bold, sans-serif font. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller, sans-serif font. The logo is simple and modern, and the use of black and white gives it a clean and professional look.
510(k) Summary Report: 5.0
TxTi™ IBF System
| Company: | Innovasis, Inc.
614 E. 3900 South
Salt Lake City, UT 84107 |
| ---------- | ------------------------------------------------------------------ |
|---|
- Marshall C. McCarty Contact: Phone: (801) 261-2236 mmccarty@innovasis.com
- Trade Name: TxTi™ IBF System
Common Name: Intervertebral Fusion Device with Bone Graft
-
Regulation No.: 21CFR 888.3080 Classification: Class: 2 Product Code: MAX Review Panel: Orthopedic
Primary Predicate Device: K180078 Innovasis TxHA® PEEK IBF System This predicate has not been subject to a design-related recall. -
K162496 Add'I Predicate Device: CoreLink Foundation™ 3D Interbody This predicate has not been subject to a design-related recall.
-
Device Description: The Innovasis TxTi IBF System is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implants are 3D printed.
The single use implant devices feature a honeycomb structure with an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration surface to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support TLIF surgeries are provided with the implants in custom sterilization trays.
- Performance Data: (Non-clinical)—Performance testing per ASTM F2077-17 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression
4
| INNOVASIS
INNOVATE / INVOLVE / INVENT | TxTi™ IBF System | 510(k)
November 2, 2018 |
| ------------------------------------------ | ------------------ | ---------------------------- |
|---|
Shear, Subsidence and Expulsion testing indicates that the TxTi IBF is substantially equivalent to the predicates.
Materials:
Implants
-
Titanium-6-Aluminum-4-Vanadium ELI (Extra Low ● Interstitial) Alloy per ASTM F3001
Instruments -
. 465 Stainless Steel per ASTM F899
-
17-4 Stainless Steel per ASTM F899 ●
-
Silicone Handles (Tested for biocompatibility)
-
Radel Handle per ASTM D6394 .
Sterilization Trays
- Anodized 5052 Aluminum ●
- . Polypropylene
- Radel .
The Innovasis TxTi IBF System is an intervertebral body fusion Intended Use: device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
Indications for Use: The Innovasis® TxTi™ Transforaminal Lumbar IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.
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Image /page/5/Picture/1 description: The image shows the logo for Innovasis. The logo is black and white and features the word "INNOVASIS" in a bold, sans-serif font. Below the word "INNOVASIS" are the words "INNOVATE / INVOLVE / INVENT" in a smaller, sans-serif font. The logo is simple and modern.
Basis for Substantial Equivalence:
The TxTi IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate devices, K180078 Innovasis TxHA® PEEK IBF System and K162496 CoreLink Foundation™ 3D Interbody.
- Technology is substantially equivalent. —
- -Design is substantially equivalent.
- Sizes are substantially equivalent. -
- -Mechanical strength is substantially equivalent.
- Indications for use are substantially equivalent. -
- -Bone graft window/cavity is substantially equivalent.
- -Materials (biocompatibility profile) are substantially equivalent.
- Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate devices.