(529 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a spinal system intended for immobilization and stabilization as an adjunct to fusion for treating various spinal instabilities and deformities, which are therapeutic medical interventions.
No
The device is a spinal system (screws, rods, links) intended for immobilization and stabilization of spinal segments as an adjunct to fusion procedures. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the system is manufactured from Ti-6Al-4V and PEEK and includes physical components such as screws, rods, links, and accessory connection components. It also describes performance studies involving mechanical testing of these components. This indicates it is a hardware-based medical device, not software-only.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The "ORION" Spinal System is a surgical implant designed to provide structural support and stabilization to the spine. It is a physical device implanted into the body during surgery.
- Lack of Diagnostic Function: The description and intended use clearly state that the system is used for immobilization and stabilization as an adjunct to fusion. It does not perform any tests on biological samples to diagnose or monitor a condition.
Therefore, based on the provided information, the "ORION" Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The "ORION" Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine : degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; scoliosis; kyphosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion.
In addition, the "ORION" Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the intended to be removed after solid fusion is achieved.
Product codes
NKB
Device Description
The "ORION" Spinal System is a system that is intended to be used for posterior thoracolumbar fusion procedures. The system is manufactured from Ti-6Al-4V which complies with ASTM F136 and PEEK which complies with ASTM F2026. The components, which are included as part of the system, include screws, rods, links, and accessory connection components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1 vertebra, L3 to Sacrum
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)
The "ORION" Spinal System has been testing in the following test modes:
- Axial Grip per ASTM F1798
- Torsional Grip per ASTM F1798
- Static Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
August 18, 2020
Orion Biotech Inc. Tun-Ling Li Chen Official Correspondent 5F-1, No.88, Sec.2, Chong-qing N. Rd., Datong Dist. Taipei, 103 Taiwan
Re: K190600
Trade/Device Name: "ORION" Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: July 20, 2020 Received: July 20, 2020
Dear Tun-Ling Li Chen:
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/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 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
1
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 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 Colin O'Neill, M.B.E. Acting 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190600
Device Name "ORION" Spinal System
Indications for Use (Describe)
The "ORION" Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine : degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; scoliosis; kyphosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion.
In addition, the "ORION" Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the intended to be removed after solid fusion is achieved.
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) |
---|---|
------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
age icy ay information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 er
3
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. §807.92.
Preparation Date: | July 20, 2020 |
---|---|
Applicant/Sponsor: | Orion Biotech Inc. |
5F-1, No.88, Sec.2, Chong-qing N. Rd., Datong Dist | |
Taipei 103, Taiwan | |
Contact Person: | Tung-Ling Li Chen |
TEL: +886 2 2550 3366 ext. 101 | |
Fax : +886 2 2559 3366 | |
Email: tunglingli@orionspine.com | |
Proprietary Name: | "ORION" Spinal System |
Common Name: | Pedicle Screw System |
Classification Name: | 21 CFR 888.3070 |
Thoracolumbosacral Pedicle Screw System |
Classification Identification: Class II
NKB Product Codes:
Predicate Device: Facilis Spinal System K161231
Device Description:
The "ORION" Spinal System is a system that is intended to be used for posterior thoracolumbar fusion procedures. The system is manufactured from Ti-6Al-4V which complies with ASTM F136 and PEEK which complies with ASTM F2026. The components, which are included as part of the system, include screws, rods, links, and accessory connection components.
4
Indications for Use:
- · The "ORION" Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine : degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion.
- · In addition, the "ORION" Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the implants is intended to be removed after solid fusion is achieved.
Technological Characteristics
The subject and predicate devices have similar technological characteristics and the minor differences do not raise any different issues of safety and effectiveness. The following characteristics are the same between the subject and predicates: Indications for use, Principles of operation, Materials of manufacture, Implant sizes, and Surgical technique.
Performance Data
The "ORION" Spinal System has been testing in the following test modes:
- Axial Grip per ASTM F1798
- Torsional Grip per ASTM F1798
- Static Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
Conclusion
The information provided in this submission demonstrate that the subject device is substantially equivalent to the predicate device.