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) 2. Trauma (including fractures) 3. Tumor 4. Spondylolisthesis 5. Spinal stenosis 6. Deformity (i.e., scoliosis, kyphosis, lordosis) 7. Pseudarthrosis 8. Failed previous fusions

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.

AI/ML Overview

This document is a 510(k) summary for the Biolign® Roto-Loc Cervical Plate System. It describes a medical device, not an AI/ML algorithm or software. Therefore, the questions related to AI/ML device performance, ground truth, sample sizes for training/test sets, expert adjudication, and multi-reader multi-case studies are not applicable.

Here's the relevant information from the document:

1. A table of acceptance criteria and the reported device performance

The document does not state specific acceptance criteria in quantitative terms for the mechanical testing results. Instead, it broadly states that "Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression bending, and static torsion per ASTM F1717." This implies that the device's performance in these tests met the standards set by ASTM F1717, making it comparable to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Meets standards of ASTM F1717 for static and dynamic compression bending, and static torsion.	The device's performance in mechanical testing (static and dynamic compression bending, and static torsion) supported substantial equivalence per ASTM F1717.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "mechanical testing" but does not detail the specific sample sizes of components tested or the provenance of any data beyond the manufacturer's location (South Africa).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical medical device, not an AI/ML system requiring expert-established ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical medical device's mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device, not an AI/ML system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in the context of "ground truth" as it applies to software. For a physical device, the "ground truth" for mechanical testing would be the physical properties and behavior of the device under stress, measured against engineering standards (like ASTM F1717).

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI/ML training sets.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device and does not involve AI/ML training sets.

Summary

{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)

K200523

Device Name Biolign® Roto-Loc Cervical Plate System

Indications for Use (Describe)

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)

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 Surgical54 De Havilland CrescentPersequor TechnoparkPretoria, 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:

Indications for Use:

1. Degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies)
1. Trauma (including fractures)
1. Tumor
1. 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.

1. Spinal stenosis
1. Deformity (i.e., scoliosis, kyphosis, lordosis)
1. 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.

Regulation Number and Section

N/A