(59 days)
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI/ML capabilities or data analysis.
Yes.
The device is used for temporary stabilization during spinal fusion, addressing conditions like degenerative disc disease, trauma, and tumors, which are therapeutic interventions.
No
The device is described as an anterior cervical plating system for temporary stabilization of the cervical spine to promote spinal fusion, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of physical components like cervical plates, locking caps, bone screws, and instrumentation, all manufactured from Titanium. This indicates a hardware-based medical device, not a software-only one.
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 the temporary stabilization of the cervical spine during spinal fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a system of plates, screws, and instrumentation made from titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Biolign® Roto-Loc Anterior Cervical Plating System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
- Degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies)
- Trauma (including fractures)
- Tumor
- Spondylolisthesis
- Spinal stenosis
- Deformity (i.e., scoliosis, kyphosis, lordosis)
- Pseudarthrosis
- Failed previous fusions
Product codes
KWQ
Device Description
The Biolign® Roto-Loc Cervical Plate system consists of cervical plates, locking caps, bone screws and all necessary instrumentation to implant the plate system. The system is manufactured from Titanium 6Al 4V (ISO 5832-3). A screw locking system is incorporated in the plate, allowing the surgeon to insert the screws, and afterwards locking the screws into place with the Biolign® Roto-Loc locking mechanism. This blocks the screw from backing out of the plate. The plates feature lordotic curvature and a transverse plane curvature for an anatomical fit to match patient pathology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
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)
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression bending, and static torsion per ASTM F1717.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 30, 2020
Elite Surgical Supplies (PTY) LTD % Jordan Floyd Project Engineer JALEX Medical 27865 Clemens Rd. Suite 3 Westlake, Ohio 44145
Re: K200523
Trade/Device Name: Biolign® Roto-Loc Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 28, 2020 Received: March 2, 2020
Dear Jordan Floyd:
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. 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
Indications for Use
510(k) Number (if known)
Device Name Biolign® Roto-Loc Cervical Plate System
Indications for Use (Describe)
The Biolign® Roto-Loc Anterior Cervical Plating System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: 1. Degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies)
-
Trauma (including fractures)
-
Tumor
-
Spondylolisthesis
-
Spinal stenosis
-
Deformity (i.e., scoliosis, kyphosis, lordosis)
-
Pseudarthrosis
-
Failed previous fusions
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 Elite Surgical. The logo features a graphic of several parallel lines on the left side. To the right of the graphic is the company name, "Elite Surgical", with the word "Elite" in larger letters above the word "Surgical".
510(k) Summary
| Submitted By: | Elite Surgical
54 De Havilland Crescent
Persequor Technopark
Pretoria, Gauteng ZA 0020 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date: | 04/29/2020 |
| Contact Person: | Jordan Floyd, Project Engineer |
| Contact Telephone: | (440) 396-4041 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Biolign® Roto-Loc Cervical Plate System |
| Regulation Description: | Spinal Intervertebral Body Fixation Orthosis |
| Regulation Number: | 21 CFR 888.3060 |
| Device Classification: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | KWQ |
| Primary Predicate Device: | Orthofix 3 Degree ACP System (K012184)
The predicate device has never been subject to a recall. |
| Additional Predicates: | Medtech Spine Cure™ OPEL-C Plate System (K181543)
The reference predicate device has never been subject to a recall. |
Device Description:
The Biolign® Roto-Loc Cervical Plate system consists of cervical plates, locking caps, bone screws and all necessary instrumentation to implant the plate system. The system is manufactured from Titanium 6Al 4V (ISO 5832-3). A screw locking system is incorporated in the plate, allowing the surgeon to insert the screws, and afterwards locking the screws into place with the Biolign® Roto-Loc locking mechanism. This blocks the screw from backing out of the plate. The plates feature lordotic curvature and a transverse plane curvature for an anatomical fit to match patient pathology.
Indications for Use:
The Biolign® Roto-Loc Anterior Cervical Plating System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
-
- Degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies)
-
- Trauma (including fractures)
-
- Tumor
-
- Spondylolisthesis
4
Image /page/4/Picture/1 description: The image shows the logo for Elite Surgical. The logo features a stylized graphic on the left, consisting of several parallel lines that curve slightly, resembling a wave or a stylized representation of surgical instruments. To the right of the graphic, the word "ELITE" is written in large, blocky, sans-serif font, with a light blue color and a subtle drop shadow effect. Below "ELITE", the word "SURGICAL" is written in a similar font style, but smaller in size.
-
- Spinal stenosis
-
- Deformity (i.e., scoliosis, kyphosis, lordosis)
-
- Pseudarthrosis
- Failed previous fusions 8.
Summary of Technological Characteristics:
The Elite Surgical Cervical Plate System and the predicates have intended use and fundamental scientific technology. All devices compare similarly in:
- Design features
- Intended use
- Materials
- Dimensions
- Function
Mechanical Testing:
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression bending, and static torsion per ASTM F1717.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.