(100 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of a cervical plate system, with no mention of AI or ML.
No.
The device is a cervical plate system used to stabilize the spine, not to treat or cure a disease directly.
No
The device is described as an implantable system for stabilizing the cervical spine, not for diagnosing medical conditions. Its intended uses are for treating existing conditions like Degenerative Disc Disease, Spondylolisthesis, and trauma, rather than identifying or characterizing them.
No
The device description clearly states it consists of plates and screws made of titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for anterior cervical fixation to stabilize the spine in patients with various conditions. This is a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details plates and screws made of titanium alloy, designed for surgical implantation.
- Anatomical Site: The device is used on the cervical spine.
- Intended User/Care Setting: The users are physicians trained in orthopedic surgery, and the setting is hospitals and surgery sites.
- Performance Studies: The performance studies mentioned are related to the mechanical properties of the implant (compression bend, torsion, screw pull-out), not diagnostic performance.
An In Vitro Diagnostic (IVD) device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Innovasis Oryx Cervical Plate System does not perform this function. It is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Innovasis Oryx Cervical Plate System is intended for use in anterior cervical fixation for the following indications:
i. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
ii. Spondylolisthesis,
iii. Trauma (i.e., fracture or dislocation)
iv. Spinal stenosis.
v. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
vi. Tumor,
vii. Pseudoarthrosis: and
viii. Previous failed fusion.
The Innovasis Oryx Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Oryx Cervical Plate System consists of a number of plates and screws of varying lengths. The plates feature lordotic curvature and a transverse plane curvature for an anatomical fit. The set contains ancillary products and instruments. All implant components are machined from implant grade titanium alloy, Ti6Al4V (ELI) per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine from C2 to C7
Indicated Patient Age Range
Not Found
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)
(Non-clinical)—Performance testing on plates per ASTM F1717 for Static and Dynamic Compression Bend and Static Torsion and ASTM F543 for bone screw Axial Pull-Out, Insertion and Removal Torque and Torsional Yield Strength indicates that the Oryx Cervical Plate System is substantially equivalent to the predicate device.
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2019
Innovasis, Inc. Marshall C. McCarty, RAC Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K192049
Trade/Device Name: Oryx™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 13, 2019 Received: August 14, 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/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
1
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 (OS) 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,
Ronald P. Jean, Ph.D. Director (Acting) 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) K192049
Device Name OryxTM Cervical Plate System
Indications for Use (Describe)
- The Innovasis Oryx Cervical Plate System is intended for use in anterior cervical fixation for the following indications: i. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc
- confirmed by history and radiographic studies),
- ii. Spondylolisthesis,
- iii. Trauma (i.e., fracture or dislocation)
- iv. Spinal stenosis.
- v. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- vi. Tumor,
- vii. Pseudoarthrosis: and
- viii. Previous failed fusion.
The Innovasis Oryx Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X 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 black and features the word "INNOVASIS" in a bold, sans-serif font. Below the logo is the text "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo is simple and modern, and the text below it suggests that the company is focused on innovation.
510(k)
510(k) Summary Report: 5.0
Oryx™ Cervical Plate System
| Company: | Innovasis, Inc. |
|---|---|
| 614 E. 3900 South | |
| Salt Lake City, UT 84107 |
Contact: Marshall McCarty Alternate: Michael Thomas Phone: (801) 261-2236 x8012 mmccarty@innovasis.com
(801) 261-2236 x8002 mthomas@innovasis.com
- Trade Name: Oryx™ Cervical Plate System
- Common Name: Anterior cervical fixation system
Regulation No.: 21CFR 888.3060 Spinal Intervertebral Body Fixation Orthosis Classification: Class 2 Product Code: KWQ Review Panel: Orthopedic Review Team: ISDT
- Primary Predicte: K030866 Synthes Anterior CSLP System
- Additional: K061147 Innovasis Opteryx Anterior Cervical Plate System
- Device Description: The Oryx Cervical Plate System consists of a number of plates and screws of varying lengths. The plates feature lordotic curvature and a transverse plane curvature for an anatomical fit. The set contains ancillary products and instruments. All implant components are machined from implant grade titanium alloy, Ti6Al4V (ELI) per ASTM F136.
- (Non-clinical)—Performance testing on plates per ASTM F1717 Performance Data: for Static and Dynamic Compression Bend and Static Torsion and ASTM F543 for bone screw Axial Pull-Out, Insertion and Removal Torque and Torsional Yield Strength indicates that the Oryx Cervical Plate System is substantially equivalent to the predicate device.
- Materials: The Oryx implants are machined from medical grade Ti6Al4V (ELI) per ASTM F136. The Orvx instruments/accessories are machined from Surgical Stainless Steel per ASTM F899 and some have medical grade Silicone handles.
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| INNOVASIS
INNOVATE / INVOLVE / INVENT | Oryx™ Cervical Plate System | 510(k)
July 31, 2019
Page 11 of 107 |
| ------------------------------------------ | ----------------------------- | ------------------------------------------- |
|---|
The Oryx sterilization trays are comprised of Anodized 5052 Aluminum and have components made of Nylon. Stainless Steel. Polypropylene, and Radel per ASTM D6394 SP031.
The Oryx Cervical Plate System is intended for use in Anterior Intended Use: Cervical Discectomy and Fusion (ACDF) procedures. 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 Oryx Cervical Plate System is intended for use in anterior cervical fixation for the following indications:
i. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
ii. Spondvlolisthesis.
iii. Trauma (i.e., fracture or dislocation)
- iv. Spinal stenosis.
v. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
vi. Tumor.
- vii. Pseudarthrosis; and
viii. Previous failed fusion.
The Innovasis Oryx Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.
Comparison of the Technological Characteristics with Predicate Device:
The Innovasis Oryx Cervical Plate System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the Synthes Anterior CSLP System (K030866) predicate.
- . Design configurations are substantially equivalent.
- . Applied mechanical loads are substantially equivalent.
- . Materials used are substantially equivalent.
- Biocompatibility requirements have been demonstrated. ●
- Intended Use and Indications for Use are substantially equivalent.
- Conclusion: Performance data and rationales submitted herein demonstrate that the subject Oryx Cervical Plate System is substantially equivalent to the predicate device with regard to design, technological characteristics, materials, performance, intended use and indications for use.