(54 days)
Not Found
No
The document describes a mechanical spinal plate system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an Anterior Cervical Plate System and Lumbar Plate Systems intended for "fixation to the cervical spine" and for "thoracic and thoracolumbar (T1 - L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1 - S1) spine instability" for various medical conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion. These uses fall under the definition of a therapeutic device as they are used to treat and manage medical conditions.
No
The devices described (FORTIS, HANA, REX, BALTEUM, and BALTEUM-ONE Anterior Cervical/Lumbar Plate Systems) are intended for surgical fixation of the spine to treat various spinal conditions, not for diagnosing them. They are implantable medical devices used in treatment, not diagnosis. The "Intended Use / Indications for Use" section clearly states their purpose is for "anterior fixation" or "temporary fixation device until fusion is achieved."
No
The device description explicitly details physical components such as plates, screws, and instruments made from titanium alloy, indicating it is a hardware medical device.
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, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that these are plate systems and screws intended for anterior fixation to the cervical, thoracic, and lumbar spine. These are physical implants used in surgical procedures.
- Intended Use: The intended use describes the clinical conditions for which these implants are used (degenerative disc disease, trauma, deformities, etc.) and the anatomical locations where they are implanted. This is consistent with surgical implants, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory analysis.
Therefore, the FORTIS, HANA, REX, BALTEUM™, and BALTEUM-ONE™ systems are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The BALTEUM™ and BALTEUM-ONE™ Lumbar Plate Systems are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 - L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The FORTIS and HANA Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for HANA and one, two, three, and four level procedures for FORTIS. Main plate is available from 13mm to 46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Rex Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also preassembled to the main plate and designed to assemble the subplate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are fixed self-tapping, Variable self-tapping screw, fixed selfdrilling screw, Variable self-drilling and are available in lengths ranging from 10mm to 20mm in 2mm increments. The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136.
The BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an anterolateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-C7 (cervical spine), T1-L5 (thoracic and thoracolumbar spine), L1-S1 (lumbar and lumbosacral spine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K121862, K173099, K200846, and K213820. No testing is required.
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.
K173099, K121862, K200846, K213820
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.
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October 18, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Dio Medical Corporation Milan George Vice President of R&D 2100 Campus Lane, Suite 100 East Norriton, Pennsylvania 19403
Re: K222572
Trade/Device Name: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 24, 2022 Received: August 25, 2022
Dear Milan George:
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 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,
Colin O'Neill, M.B.E. 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222572
Device Name
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System
Indications for Use (Describe)
The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The BALTEUM™ and BALTEUM-ONE™ Lumbar Plate Systems are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 - L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until 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.
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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
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510(k) SUMMARY
Dio Medical
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System
| Sponsor: | Manufacturer: | Dio Medical Corp.
2100 Campus Lane, Suite 100
East Norriton, PA 19403 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Official Contact: | Milan George |
| | Email: | mgeorge@dio-us.com |
| | Phone: | 1-877-394-5407 ext.102 |
| Date Prepared: | August 24, 2022 | |
| Device Names: | FORTIS and HANA Anterior Cervical Plate System,
Rex Anterior Cervical Plate System, and
BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System | |
| Common Name: | Anterior Cervical Plate System, Spinal Implants, Spinal Fixation
Device, Lumbar Plate System | |
| Classification Name: | Spinal intervertebral body fixation orthosis | |
| Classification Number: | 21 CFR 888.3060 | |
| Product Code/
Classification: | KWQ, class II | |
| Description: | The FORTIS and HANA Anterior Cervical Plate System consists of
a variety of shapes and sizes of Main Plates, screw, lock-plate
and the associated instruments. The lock-plate is pre-assembled
to the main plate and designed to prevent screws from backing
out. Each component is subjected to a color anodizing process to
differentiate the screw type and diameter and to make the
surgical process easy. The plates range in length to
accommodate one and two-level procedures for HANA and one,
two, three, and four level procedures for FORTIS. Main plate is
available from 13mm to 46mm for HANA and 10mm to 112mm
for FORTIS. Screws are available in lengths from 12mm to 20mm
for HANA and 10mm to 20mm in 2mm increments for FORTIS.
The screws have either a 4.5mm or 5.1mm diameter for HANA
and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-
tapping, variable self-tapping screw, fixed self-drilling screw,
variable self-drilling | |
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The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Rex Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also preassembled to the main plate and designed to assemble the subplate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are fixed self-tapping, Variable self-tapping screw, fixed selfdrilling screw, Variable self-drilling and are available in lengths ranging from 10mm to 20mm in 2mm increments. The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136.
The BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an anterolateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.
Indications for Use: The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
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| | The REX Anterior Cervical Plate System is intended for anterior
fixation to the cervical spine. The specific clinical indications
include:
degenerative disc disease (DDD) (defined as neck pain of
discogenic origin with degeneration of the disc confirmed by
history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures
(i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis,
and failed previous fusion. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The BALTEUM™ and BALTEUM-ONE™ Lumbar Plate Systems are
intended for use via a lateral or anterolateral surgical approach
above the bifurcation of the great vessels in the treatment of
thoracic and thoracolumbar (T1-L5) spine instability or via the
anterior surgical approach, below the bifurcation of the great
vessels in the treatment of lumbar and lumbosacral (L1-S1) spine
instability as a result of fracture (including dislocation and
subluxation), tumor, degenerative disc disease (defined as back
pain of discogenic origin with degeneration of the disc confirmed
by patient history and radiographic studies), scoliosis, kyphosis,
lordosis, spinal stenosis, or a failed previous spine surgery. The
device is intended as a temporary fixation device until fusion is
achieved. |
| Predicate
Device: | Primary Predicate:
Huvexel Co. Ltd. - FORTIS and HANA Anterior Cervical Plate
System (K173099) |
| | Additional predicates:
Huvexel Co. Ltd.: Rex Anterior Cervical Plate System (K121862)
Rex Anterior Cervical Plate System, and
Huvexel Co. Ltd.: BALTEUM™ & BALTEUM-ONE™ Lumbar Plate
System(K200846, K213820) |
| Substantial
Equivalence: | The FORTIS and HANA Anterior Cervical Plate System, Rex Anterior
Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar
Plate System are identical to the predicate devices and are as safe
and effective as the Huvexel - FORTIS and HANA Anterior Cervical
Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ &
BALTEUM-ONE™ Lumbar Plate System. The Subject device has the
same intended uses and similar indications, technological
characteristics, and principles of operation as its predicate device.
There are no technological differences between the Subject device
and their predicate devices resulting in no new issues of safety or
effectiveness. Thus, the Dio Medical - FORTIS and HANA Anterior |
| | Cervical Plate System, Rex Anterior Cervical Plate System, and
BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System are
identical/substantially equivalent to the predicates. |
| Performance
Data: | The subject and predicate devices are identical and therefore, no
performance testing is required. Submission is only transferring
name of a system that has already been cleared under K121862,
K173099, K200846, and K213820. No testing is required. |
| Conclusion: | The Dio Medical- FORTIS and HANA Anterior Cervical Plate System,
Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System have the same intended uses and
similar indications, technological characteristics, and principles of
operation as their predicate device. Thus, the subject devices are
identical/substantially equivalent to the predicate devices. |
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