OMNIBotics Knee System

K200888 · Corin, Ltd. · OLO · Jun 27, 2020 · Neurology

Device Facts

• Record ID: K200888
• Device Name: OMNIBotics Knee System
• Applicant: Corin, Ltd.
• Product Code: OLO · Neurology
• Decision Date: Jun 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The OMNIBotics Knee System is indicated for stereotaxic surgery to aid the surgeon in locating and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The BalanceBot™ is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics Knee System supports OMNI Apex Knee™ implants and CORIN Unity Knee™ implants.

Device Story

Computer-assisted navigation system for Total Knee Arthroplasty (TKA); assists surgeons in locating anatomical structures and aligning endoprostheses. System components: OMNIBotics Station (3D optoelectronic localizer, laptop with ART Knee software, touchscreen, external monitor, footswitch), OMNIBot cutting guide (femoral bone resections), BalanceBot (active motorized spacer/ligament tensioner), and OMNIBotics Tracker Kit (single-use reflective markers). Used in OR by surgeons/staff. Optical localizer tracks reflective markers on instruments to provide real-time spatial reference. Software processes tracking data to guide bone cuts and implant positioning. BalanceBot adjusts soft tissue and femoral implant to optimize joint stability and reduce flexion gap asymmetry. Provides surgeons with intraoperative visualization and guidance for precise implant placement; aims to improve TKA outcomes through enhanced alignment and soft tissue balancing.

Clinical Evidence

Bench testing and cadaver studies. Four surgeons performed ten cadaver surgeries to verify performance, accuracy of bone resections, implant positioning, gap magnitude, and joint stability. Simulated use testing validated marker precision, accuracy, and usability. Sterility validated per NF EN ISO 11137-2:2015 (25 kGy gamma radiation). Endotoxin levels met ANSI/AAMI ST72 criteria; markers confirmed non-cytotoxic per ISO 10993-5.

Technological Characteristics

Stereotaxic navigation system; 3D optoelectronic localizer; motorized bone cutting guide; active motorized knee spacer (BalanceBot). Connectivity via control box at station base. Single-use reflective markers (gamma sterilized per ISO 11137-2). Software-driven navigation and alignment. Biocompatible materials per ISO 10993-5.

Indications for Use

Indicated for patients undergoing Total Knee Arthroplasty requiring stereotaxic surgical assistance for implant alignment and soft tissue/femoral implant adjustment to address flexion gap asymmetry.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• OMNIBotics Knee System (K163338)

Reference Devices

• Unity™ Total Knee System (K113060, K173884, K170808, K183533)

Submission Summary (Full Text)

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June 27, 2020

Corin Ltd. % Robert A. Poggie President Bio Vera Inc. 65 Promenade Saint Louis Notre Dame de LIle Perrot, Quebec J7v7p2 Canada

Re: K200888

Trade/Device Name: OMNIBotics Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 31, 2020 Received: April 3, 2020

Dear Robert Poggie:

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.

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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 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200888

Device Name

OMNIBotics Knee System

#### Indications for Use (Describe)

The OMNIBotics Knee System is indicated for stereotaxic surgery to aid the surgeon in locating and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The BalanceBot™ is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics Knee System supports OMNI Apex Knee™ implants and CORIN Unity Knee™ implants.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------|-------------------------------------------------------------------|
| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) SUMMARY

# The OMNIBotics® Knee System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the OMNIBotics® Knee System.

### A. SUBMITTERS INFORMATION

| Submitter Name: | BioVera, Inc. |
|---------------------|----------------------------------------------------------------------------------|
| Submitter Address: | 65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, Quebec,<br>J7V 7P2, CANADA |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date of Submission: | March 31, 2020 |

### B. DEVICE IDENTIFICATION & MANUFACTURER

| Manufacturer Name: | Corin Ltd. |
|-----------------------|----------------------------------------------|
| Manufacturer Address: | 480 Paramount Drive, Raynham, MA, 02767, USA |
| Registration Number: | 1226188 |
| Contact Name: | Christina Rovaldi |
| Title: | Regulatory Affairs Specialist |
| Device Trade Name: | OMNIBotics® Knee System |
| Device Common Name: | Stereotaxic instrument |
| Classification Name: | Stereotaxic instrument |
| Classification Code: | OLO - Class II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR 882.4560 |

### C1. PRIMARY PREDICATE DEVICE

K163338 OMNIIife Science Inc., OMNIBotics® Knee System

### C2. REFERENCE DEVICE

| K113060, K173884<br>K170808, K183533 | Corin Ltd. Unity™ Total Knee System | |
|--------------------------------------|-------------------------------------|--|
|--------------------------------------|-------------------------------------|--|

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#### D. DEVICE DESCRIPTION

The OMNIBotics® Knee system is a computer-assisted navigation system with a motorized bone cutting quide that is used by surqeons and operating room (OR) staff to assist in performing stereotaxic total knee arthroplasty (TKA). The OMNIBotics® Knee System consists of the OMNIBotics® Station, ART Knee Application software, the OMNIBot cutting quide for quiding femoral bone resections, the BalanceBot defined as an active (motorized) knee spacer and ligament tensioning device, and the OMNIBotics™ Tracker Kit which is comprised of single-use reflective markers that are fixed onto the associated instruments that provide a frame of reference for tracking by the 3D optical optoelectronic localizer.

The OMNIBotics® Station includes the 3D optoelectronic localizer mounted on an articulated arm, a laptop hosting the ART Knee Software and equipped with a touchscreen, an external LCD monitor and a three-button footswitch as a means for the user to interact with the system. The power supply and communication hardware required for the camera, the laptop, the OMNIBot, and BalanceBot are contained within a single enclosure, the control box, located at the base of the OMNIBotics® Station.

The OMNIBotics® Knee System was originally cleared for use with OMNI Apex Knee™ System implants in K163338. This 510(k) notification demonstrates substantial equivalence of the OMNIBotics® Knee System for use with Corin Unity™ Total Knee System implants.

#### E. INTENDED USE

The OMNIBotics® Knee System is indicated for stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The BalanceBot™ is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ implants and CORIN Unity Knee™ implants.

### F. TECHNOLOGICAL CHARACTERISTICS

The technology of the subject device OMNIBotics Knee System is the same as the predicate device OMNIBotics Knee System, K163338. The basis for this 510(k) notification are three-fold:

- (1) New and modified instruments and software for the OMNIBotics Knee System to function with the Corin Unity Knee system,
- (2) Change in manufacturer for the single-use reflective markers and associated validations of functionality and manufacturing processes, and
- (3) Updated labeling, software, and hardware validations regarding the above changes.

Validation and verification testing for the subject device OMNIBotics Knee System included precision and accuracy of the single-use reflective markers (and arrays), sterility, shelf life, and biocompatibility of the reflective markers (The OMNIBotics® Tracker Kit), and surgeon-user evaluation of Corin Unity knee implants in cadaver knees. The results of these tests showed the subject OMNIBotics® Knee System to perform substantially equivalently to the predicate device.

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### G. PERFORMANCE DATA

The following tests and studies were performed to validate and verify the subject OMNIBotics Knee System to perform substantially equivalently to the predicate device.

- . Surgeon-user verification studies of performance measures and accuracy performed by four (4) surgeons in ten (10) cadaver surgeries. The results of the cadaver evaluation demonstrated that the subject device met the established criteria for user requirements. usability, accuracy of bone resections, accuracy of implant position, magnitude of gaps, and joint stability.
- Simulated use and validation testing of precision, accuracy, and usability of the reflective markers / marker arrays.
- . Sterility of the OMNIBotics® Tracker Kit was validated for a sterilization dose of 25 kGy of gamma radiation according to the VD max method NF EN ISO 11137-2: 2015.
- . Endotoxin testing of the single-use reflective markers was performed according to ANSI/AAMI ST72. 5.2. The endotoxin levels for the markers were determined to be well within the minimum acceptance criteria. The single use markers were determined to be non-cytotoxic per ISO 10993-5.

The results of performance testing and process validations demonstrated substantial equivalence of the subject, predicate, and reference devices.

### H. CONCLUSION

The OMNIBotics® Knee System used with Corin Unity knee implants was determined to be substantially equivalent to the predicate device OMNIBotics® Knee System (K163338).