(253 days)
No
The device descriptions and intended uses are for passive spinal implants and associated instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device descriptions consistently state that these systems are "temporary," "stabilize the cervical spinal operative site during the fusion process," or "help provide temporary stabilization until a solid spinal fusion develops." The intended use also lists various medical conditions that these devices are designed to address for "fixation." This indicates that the devices are used to treat or alleviate a medical condition.
No.
The device descriptions consistently state that these systems are "temporary implants" or "fixation devices" intended to stabilize the spine during a fusion process. There is no mention of these devices being used to diagnose conditions.
No
The device description clearly states that the system is comprised of physical components such as plates, screws, and associated instrumentation made of titanium alloy, which are implanted into the spine. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, none of these devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device descriptions clearly state that these devices are implants designed for surgical fixation of the spine. They are physically placed within the patient's body to provide structural support and stabilization.
- IVDs are used to provide information for diagnosis, monitoring, or treatment. While these implants are used in the treatment of various spinal conditions, they do not diagnose or monitor these conditions by analyzing biological samples. Their function is mechanical and structural.
The information provided describes surgical implants, not devices that analyze biological samples outside of the body.
N/A
Intended Use / Indications for Use
3° Anterior Cervical Plating System
The 3° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
-
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
-
- Pseudoarthrosis
-
- Revision of previous surgery
Reliant Anterior Cervical Plating System
The Reliant Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
-
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
-
- Pseudoarthrosis
-
- Revision of previous surgery
Unity Lumbosacral Fixation System
The Unity Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, the system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
-
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Pseudoarthrosis.
-
- Spondvlolvsis.
-
- Spondylolisthesis.
-
- Fracture.
-
- Neoplastic disease.
-
- Unsuccessful previous fusion surgery.
-
- Lordotic deformities of the spine.
-
- Idiopathic thoracolumbar or lumbar scoliosis.
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
-
- Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
Hallmark Anterior Plate System
The Hallmark Anterior Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
-
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
-
- Pseudoarthrosis
-
- Revision of previous surgery
NewBridge Laminoplasty Fixation System
The NewBridge Laminoplasty Fixation System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The system holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.
CETRA Anterior Cervical Plate System
The CETRA Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
-
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
-
- Pseudoarthrosis
-
- Revision of previous surgery
Product codes
KWQ, NQW
Device Description
3° Anterior Cervical Plating System - The 3° Anterior Cervical Plating System is a temporary titanium alloy (Ti6Al-4V ELI, per ASTM F136) system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assists in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.
Reliant Anterior Cervical Plating System - The Reliant Anterior Cervical Plating System is temporary, titanium alloy system comprised of a variety of single-use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assist in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.
Unity Lumbosacral Fixation System - The Unity Lumbosacral Fixation System consists of the Unity 51 Lumbosacral Fixation Plate for lumbosacral fixation and the Unity LX Lumbar Fixation Plate for anterior or anterolateral fixation above L5-S1.
The Unity 51 Lumbosacral Fixation Plate is designed specifically for supplemental fixation of anterior lumbar fusions at the L5-S1 level. The plate is contoured to the unique anatomy of the L5-S1 segment. The Unity 51 Plate is available in six heights: 17mm to 25mm in 2mm increments and one additional plate at 28mm.
The Unity LX Lumbar Fixation Plate is designed for lumbar levels above L5-S1 in 2 configurations - anterior and anterolateral. In the anterolateral configuration, the plate allows surgeons lateral-to-medial placement of the self-neuro foramen. The Unity LX Plate is available in six heights: 19mm to 25mm in 2mm increments and two additional plates at 28mm and 31mm.
Hallmark Anterior Plate System – The Hallmark Anterior Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V-ELI, per ASTM F136) components that allow a surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.
NewBridge Laminoplasty Fixation System – The NewBridge Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium alloy components. The specially shaped plates, made of commercially pure (CP) titanium conforming to ASTM F67, are designed to fit the anatomy of a dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.
The screws, made of titanium alloy (Ti-6AI-4V ELI, per ASTM F136) are available in a variety of lengths and diameters in order to meet individual anatomical requirements.
The NewBridge Laminoplasty Fixation System must always be used with an allograft.
CETRA Anterior Cervical Plate System – The CETRA Anterior Cervical Plate System is comprised of an assortment of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body, by means of screws to the cervical spine. The system includes the necessary instrumentation to assist in the surgical implantation of the devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C7), Lumbosacral spine (L5-S1), Lumbar region of the spine above L5-S1, lower cervical and upper thoracic spine (C3-T3)
Indicated Patient Age Range
Not Found
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)
In accordance to the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the following testing was conducted:
- . ASTM F2052-15 - Standard test method for measurement of magnetically induced displacement force on passive implants in the maqnetic resonance environment
- . ASTM F2213-17 - Standard test method for measurement of maqnetically induced torque on medical devices in the magnetic resonance environment
- . ASTM F2119-07 – Standard test method for evaluation of MR image artifacts from passive implants
- ASTM F2182-19E2 - Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020620, K030595, K061229, K100614, K043338, K162638
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 11, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Orthofix US LLC Jacki Koch Principle Regulatory Affairs 3451 Plano Parkway Lewisville, Texas 75056
Re: K211712
Trade/Device Name: 3 Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ, NQW Dated: January 4, 2022 Received: January 10, 2022
Dear Jacki Koch:
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,
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
2
510(k) Number (if known) K211712
Device Name
3° Anterior Cervical Plating System
Indications for Use (Describe)
The 3° Anterior Cervical Plating System is intenor fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
-
- Pseudoarthrosis
-
- Revision of previous surgery
| 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)
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 PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K211712
Device Name
Reliant Anterior Cervical Plating System
Indications for Use (Describe)
The Reliant Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
-
- Pseudoarthrosis
-
- Revision of previous surgery
| 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)
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 PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K211712
Device Name
Unity Lumbosacral Fixation System
Indications for Use (Describe)
The Unity Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, the system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Pseudoarthrosis.
-
- Spondylolysis.
-
- Spondylolisthesis.
-
- Fracture.
-
- Neoplastic disease.
-
- Unsuccessful previous fusion surgery.
-
- Lordotic deformities of the spine.
-
- Idiopathic thoracolumbar or lumbar scoliosis.
-
Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
-
Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity.
| 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 PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K211712
Device Name
Hallmark Anterior Plate System
Indications for Use (Describe)
The Hallmark Anterior Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
-
- Pseudoarthrosis
-
- Revision of previous surgery
| 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)
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 PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K211712
Device Name
NewBridge Laminoplasty Fixation System
Indications for Use (Describe)
The NewBridge Laminoplasty Fixation System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The system holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.
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 PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K211712
Device Name
CETRA Anterior Cervical Plate System
| Indications for Use ( Describe ) | |
|---|---|
| ----------------------------------------- | -- |
The CETRA Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
-
- Spondylolisthesis
-
- Fracture
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
-
- Pseudoarthrosis
-
- Revision of previous surgery
| 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 PRAStaff(@fda.hhs.gov
8
510(k) SUMMARY
3° Anterior Cervical Plating System Reliant Anterior Cervical Plating System Unity Lumbosacral Fixation System Hallmark Anterior Plate System NewBridge Laminoplasty Fixation System CETRA Anterior Cervical Plate System
510(k) Owner Information
| Name:
Address: | Orthofix US LLC
3451 Plano Parkway
Lewisville, TX 75056 |
|-----------------------------------------------------|---------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214-937-2100
214-937-3322
jackikoch@orthofix.com |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch, Regulatory Affairs Program Manager |
| Date Prepared: | February 10, 2022 |
| Name of Device
Trade Name / Proprietary
Name: | |
3° Anterior Cervical Plating System Reliant Anterior Cervical Plating System Unity Lumbosacral Fixation System Hallmark Anterior Plate System NewBridge Laminoplasty Fixation System CETRA Anterior Cervical Plate System
Product Code(s):
| System Name | Product Codes |
|---|---|
| 3° Anterior Cervical Plating System | KWQ |
| Reliant Anterior Cervical Plating System | KWQ |
| Unity Lumbosacral Fixation System | KWQ |
| Hallmark Anterior Plate System | KWQ |
| NewBridge Laminoplasty Fixation System | NQW |
| CETRA Anterior Cervical Plate System | KWQ |
Classification Name(s)
| System Name | Classification Name |
|---|---|
| 3° Anterior Cervical Plating System | Spinal Intervertebral Body Fixation Orthosis |
| Reliant Anterior Cervical Plating System | Spinal Intervertebral Body Fixation Orthosis |
| Unity Lumbosacral Fixation System | Spinal Intervertebral Body Fixation Orthosis |
| Hallmark Anterior Plate System | Spinal Intervertebral Body Fixation Orthosis |
| NewBridge Laminoplasty Fixation System | Spinal Interlaminal Fixation Orthosis |
9
Image /page/9/Picture/1 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. The "®" symbol is located to the upper right of the "X" in "ORTHOFIX".
CETRA Anterior Cervical Plate System Spinal Intervertebral Body Fixation Orthosis
Device Classification
| System Name | Product Codes |
|---|---|
| 3° Anterior Cervical Plating System | Class II per 21 CFR § 888.3060 |
| Reliant Anterior Cervical Plating System | Class II per 21 CFR § 888.3060 |
| Unity Lumbosacral Fixation System | Class II per 21 CFR § 888.3060 |
| Hallmark Anterior Plate System | Class II per 21 CFR § 888.3060 |
| NewBridge Laminoplasty Fixation System | Class II per 21 CFR § 888.3050 |
| CETRA Anterior Cervical Plate System | Class II per 21 CFR § 888.3060 |
Review Panel: Orthopedic Device Panel
3° Anterior Cervical Plating System (K020620) Predicate Devices: Reliant Anterior Cervical Plating System (K030595) Unity Lumbosacral Fixation System (K061229) Hallmark Anterior Plate System (K100614) NewBridge Laminoplasty Fixation System (K043338) CETRA Anterior Cervical Plate System (K162638)
Reason for 510(k) Submission:
Orthofix is submitting this Traditional 510(k) premarket notification for the addition of MR Conditional labeling to the subject medical devices.
The subject addition of MR Conditional labeling does not change the design, intended use, materials, performance specifications or the indications for use as previously cleared.
Device Description
3° Anterior Cervical Plating System - The 3° Anterior Cervical Plating System is a temporary titanium alloy (Ti6Al-4V ELI, per ASTM F136) system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assists in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.
Reliant Anterior Cervical Plating System - The Reliant Anterior Cervical Plating System is temporary, titanium alloy system comprised of a variety of single-use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assist in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.
Unity Lumbosacral Fixation System - The Unity Lumbosacral Fixation System consists of the Unity 51 Lumbosacral Fixation Plate for lumbosacral fixation and the Unity LX Lumbar Fixation Plate for anterior or anterolateral fixation above L5-S1.
The Unity 51 Lumbosacral Fixation Plate is designed specifically for supplemental fixation of anterior lumbar fusions at the L5-S1 level. The plate is contoured to the unique anatomy of the L5-S1 segment. The Unity 51 Plate is available in six heights: 17mm to 25mm in 2mm increments and one additional plate at 28mm.
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The Unity LX Lumbar Fixation Plate is designed for lumbar levels above L5-S1 in 2 configurations - anterior and anterolateral. In the anterolateral configuration, the plate allows surgeons lateral-to-medial placement of the self-neuro foramen. The Unity LX Plate is available in six heights: 19mm to 25mm in 2mm increments and two additional plates at 28mm and 31mm.
Hallmark Anterior Plate System – The Hallmark Anterior Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V-ELI, per ASTM F136) components that allow a surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.
NewBridge Laminoplasty Fixation System – The NewBridge Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium alloy components. The specially shaped plates, made of commercially pure (CP) titanium conforming to ASTM F67, are designed to fit the anatomy of a dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.
The screws, made of titanium alloy (Ti-6AI-4V ELI, per ASTM F136) are available in a variety of lengths and diameters in order to meet individual anatomical requirements.
The NewBridge Laminoplasty Fixation System must always be used with an allograft.
CETRA Anterior Cervical Plate System – The CETRA Anterior Cervical Plate System is comprised of an assortment of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body, by means of screws to the cervical spine. The system includes the necessary instrumentation to assist in the surgical implantation of the devices.
Intended Use / Indications for Use
3° Anterior Cervical Plating System
The 3° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
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- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
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- Spondylolisthesis
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- Fracture
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- Spinal stenosis
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- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
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- Tumor
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- Pseudoarthrosis
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- Revision of previous surgery
Reliant Anterior Cervical Plating System
The Reliant Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
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- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
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- Spondylolisthesis
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- Fracture
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Image /page/11/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. There is a small "®" symbol in the upper right corner of the word "ORTHOFIX".
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- Spinal stenosis
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- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
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- Tumor
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- Pseudoarthrosis
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- Revision of previous surgery
Unity Lumbosacral Fixation System
The Unity Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, the system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
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- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
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- Pseudoarthrosis.
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- Spondvlolvsis.
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- Spondylolisthesis.
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- Fracture.
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- Neoplastic disease.
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- Unsuccessful previous fusion surgery.
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- Lordotic deformities of the spine.
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- Idiopathic thoracolumbar or lumbar scoliosis.
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- Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
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- Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
Hallmark Anterior Plate System
The Hallmark Anterior Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
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- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
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- Spondylolisthesis
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- Fracture
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- Spinal stenosis
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- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
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- Tumor
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- Pseudoarthrosis
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- Revision of previous surgery
NewBridge Laminoplasty Fixation System
The NewBridge Laminoplasty Fixation System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The system holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.
CETRA Anterior Cervical Plate System
The CETRA Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
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- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
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- Spondylolisthesis
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- Fracture
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Image /page/12/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black bold letters. A small registration mark is present to the right of the word "ORTHOFIX".
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- Spinal stenosis
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- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
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- Tumor
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- Pseudoarthrosis
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- Revision of previous surgery
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The Technological Characteristics, design, dimensions, intended use, materials and performance characteristics of the subject devices are unchanged from their previous clearance. The purpose of this 510(k) submission is for the addition of MR Conditional to the device labeling.
PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
In accordance to the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the following testing was conducted:
- . ASTM F2052-15 - Standard test method for measurement of magnetically induced displacement force on passive implants in the maqnetic resonance environment
- . ASTM F2213-17 - Standard test method for measurement of maqnetically induced torque on medical devices in the magnetic resonance environment
- . ASTM F2119-07 – Standard test method for evaluation of MR image artifacts from passive implants
- ASTM F2182-19E2 - Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging
Basis of Substantial Equivalence
As stated throughout this 510(k) notification, there are no modifications to the design, intended use, or indications for use. The purpose of this 510(k) notification is for the addition of MR Conditional labeling for the subject devices.
The subject devices are temporary, multiple component systems comprised of a variety of single use components, made of titanium alloy. There have been no changes to the design, to the material, intended use or indications for use.
Therefore, the subject devices are identical to themselves as previously cleared.
In accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," the following testing was conducted to determine that the subject devices met requirements necessary for MRI Conditional labeling:
- ASTM F2052-15 "Standard test method for measurement of magnetically induced ● displacement force on passive implants in the magnetic resonance environment"
- . ASTM F2213-17 - "Standard test method for measurement of maqnetically induced torque on medical devices in the magnetic resonance environment"
- ASTM F2119-07 "Standard test method for evaluation of MR image artifacts from ● passive implants"
- ASTM F2182-19E2 "Standard test method for measurement of radio frequency induced ● heating on or near passive implant during magnetic resonance imaging"
- ASTM F2503 "Standard practice for marking medical devices and other items for safety ● in the magnetic resonance environment"