(100 days)
Not Found
No
The device description and intended use clearly define a physical intervertebral body fusion cage made of titanium alloy. There is no mention of software, algorithms, image processing, or any other components that would typically incorporate AI/ML. The performance studies are focused on mechanical testing of the physical device.
Yes
The device is an intervertebral body fusion cage intended to facilitate fusion in patients with degenerative disc disease, which directly addresses a medical condition to restore function and alleviate symptoms.
No
The device is described as an "intervertebral body fusion cage" used to facilitate fusion in the spine, not to diagnose a condition. Its function is therapeutic (fusion), not diagnostic.
No
The device description clearly states that the device is a physical intervertebral body fusion cage made of Titanium alloy, which is a hardware component.
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 ORIO-Ti cervical and lumbar intervertebral body fusion cages are physical implants designed to be surgically placed in the spine to facilitate bone fusion. They are used to treat degenerative disc disease and are implanted with bone graft.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic testing on biological samples. Its function is purely therapeutic and structural.
The information provided clearly describes a surgical implant used for treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment with an intervertebral cage. ORIO-Ti cervical intervertebral body fusion implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ORIO-Ti cervical intervertebral body fusion implant is to be used with supplemental fixation that has been cleared for use in the cervical spine.
The ORIO-Ti lumbar intervertebral body fusion cage is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six (6) months of non-operative treatment. ORIO-Ti lumbar intervertebral body fusion implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral, or lateral approach. The ORIO-Ti lumbar intervertebral body fusion implants are to be used with supplemental fixation that have been cleared for use in the lumbosacral spine.
Product codes
ODP, MAX
Device Description
The subject devices are intervertebral body fusion devices for use in cervical lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped or trapezoidal shaped with windows or pockets in their design to allow for the placement of autograft or allogenic bone graft. The ORIO-Ti Cage System is a Titanium alloy interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: as a single device via an anterior cervical (ACDF), bilaterally in pairs via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via an anterior (ALIF) approach. The exterior of the devices has "teeth" on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C-3 to C-7 disc levels, 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 Test Summary:
The following tests were conducted:
- Static and dynamic axial compression (ASTM F2077-18)
- Static and dynamic shear-compression (ASTM F2077-18)
- Static and dynamic Torsion (ASTM F2077-18)
- Subsidence (ASTM F2267-04 Reapproved 2018)
- Expulsion (MED-SPN-EXP 2nd Edition, Rev. 0)
The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems.
Clinical Test Summary:
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K090887, P980048, K170569, K173080, K123045
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
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September 30, 2021
SpineCraft, LLC Ami Akallal-Asaad Vice President of Regulatory Affairs & Quality Assurance 777 Oakmont Lane, Suite 200 Westmont, Illinois 60559
Re: K211935
Trade/Device Name: ORIO-Ti Intervertebral Body Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: August 27, 2021 Received: September 2, 2021
Dear Ms. Akallal-Asaad:
We have reviewed vour 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/ofdocs/cfpmn/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
1
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 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 mediation-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 Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211935
Device Name
ORIO-Ti Intervertebral Body Fusion Cage System
Indications for Use (Describe)
The ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment with an intervertebral cage. ORIO-Ti cervical intervertebral body fusion implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ORIO-Ti cervical intervertebral body fusion implant is to be used with supplemental fixation that has been cleared for use in the cervical spine.
The ORIO-Ti lumbar intervertebral body fusion cage is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six (6) months of non-operative treatment. ORIO-Ti lumbar intervertebral body fusion implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral, or lateral approach. The ORIO-Ti lumbar intervertebral body fusion implants are to be used with supplemental fixation that have been cleared for use in the lumbosacral spine.
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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510(k) Summary
SpineCraft ORIO-Ti Intervertebral Body Fusion Cage System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ORIO-Ti Cage System.
Date Prepared: August 27, 2021
| 1. Submitter: | Contact Person: |
|---|---|
| SpineCraft, LLC | Ami Akallal-Asaad |
| 777 Oakmont Lane | VP, Regulatory Affairs & QA |
| Westmont, IL 60559 USA | SpineCraft, LLC |
| Tel: 1 630-920-7300. | a.asaad@spinecraft.com |
| Fax: 1 630-920-7310 |
- ORIO-Ti Intervertebral Body Fusion Cage System 2. Trade name:
| Common Name: | Intervertebral body fusion device |
|---|---|
| Classification Name: | Intervertebral body fusion device - Cervical per ODP 21 CFR 888.3080 |
| Intervertebral body fusion device - Lumbar per MAX 21 CFR 888.3080 | |
| Class II |
3. Predicate or legally marketed devices which are substantially equivalent:
Primary
- ORIO Intervertebral Body Fusion Cages (K090887) SpineCraft, LLC .
Additional predicate devices
- . BAK/C Vista Interbody Fusion (P980048) Zimmer
- . Shoreline ACS Anterior Cervical Standalone (K170569) SeaSpine
- IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080) Huvexel Co., Ltd ●
- Brigade Hyperlordotic ALIF Lumbar Cage (K123045) Nuvasive ●
- APEX-DL Spine System (K143683) SpineCraft, LLC
- ASTRA Spine System (K150417) SpineCraft, LLC ●
4. Description of the device:
The subject devices are intervertebral body fusion devices for use in cervical lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally boxshaped or trapezoidal shaped with windows or pockets in their design to allow for the placement of autograft or allogenic bone graft. The ORIO-Ti Cage System is a Titanium alloy interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: as a single device via an anterior cervical (ACDF), bilaterally in pairs via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via an anterior (ALIF) approach. The exterior of the devices has "teeth" on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.
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Materials:
Titanium alloy Ti-6Al-4V ELI per ASTM F136.
Summary of Similarities and Differences in Technological Characteristics and Performance 5.
ORIO-Ti Intervertebral Body Fusion Cage System is substantially equivalent to the ORIO cervical caqe (K090887), the the BAK/C Vista (P980048), the Shoreline ACS (K170569), the ORIO lumbar cages (K090887), IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080) , the Brigade Hyperlordotic ALIF Lumbar Cage (K123045) in terms of intended use, design, materials used, mechanical safety and/or performances.
6. Indications for Use:
The ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. ORIO-Ti cervical intervertebral body fusion implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ORIO-Ti cervical intervertebral body fusion implant is to be used with supplemental fixation that has been cleared for use in the cervical spine.
The ORIO-Ti lumbar intervertebral body fusion cage 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. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six (6) months of non-operative treatment. ORIO-Ti lumbar intervertebral body fusion implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral, or lateral approach. The ORIO-Ti lumbar intervertebral body fusion implants are to be used with supplemental fixation that have been cleared for use in the lumbosacral spine.
Non-clinical Test Summary: 7.
The following tests were conducted:
- . Static and dynamic axial compression (ASTM F2077-18)
- . Static and dynamic shear-compression (ASTM F2077-18)
- Static and dynamic Torsion (ASTM F2077-18) ●
- . Subsidence (ASTM F2267-04 Reapproved 2018)
- Expulsion (MED-SPN-EXP 2nd Edition, Rev. 0) ●
The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems.
8. Clinical Test Summary
No clinical studies were performed
Conclusions Nonclinical and Clinical 9.
Based on the supporting evidence provided, we believe that the subject ORIO-Ti Cage System is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.