Who is the manufacturer of 360CAS?

Kico Knee Innovation Company Pty Limited filed the 510(k) submission for 360CAS (K213380).

What is the FDA product code for 360CAS?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for 360CAS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for 360CAS?

Stryker OrthoMap Precision Knee System (K162341); Stryker OrthoMap Versatile Hip System (K162937).

Who can help prepare an FDA 510(k) submission like 360CAS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

360CAS

K213380 · Kico Knee Innovation Company Pty Limited · OLO · Jan 11, 2022 · Neurology

Device Facts

Record ID	K213380
Device Name	360CAS
Applicant	Kico Knee Innovation Company Pty Limited
Product Code	OLO · Neurology
Decision Date	Jan 11, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures. The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified. The 360CAS Knee is indicated for the following surgical procedures: - Total Knee Arthroplasty (TKA) - For conditions of the knee joint in which the use of computer assisted surgery may be appropriate The 360CAS Hip is indicated for the following surgical procedures: - Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used - For conditions of the hip joint in which the use of computer assisted surgery may be appropriate

Device Story

360CAS is a stereotaxic surgical navigation system for orthopaedic procedures (TKA/THA). System inputs include spatial data from passive optical trackers attached to surgical instruments (pointer, bone fixator) and patient anatomy. Navigation software processes these inputs to map patient morphology, navigate instruments/implants, and assess joint state. Output is visual guidance displayed on a monitor for the surgeon. Used in OR by trained orthopaedic surgeons; provides intraoperative guidance to assist in alignment and positioning of implants. Benefits include improved surgical accuracy and planning. System components: navigation software (Knee/Hip modules), surgical instruments, spatial tracking components, and navigation cart.

Clinical Evidence

No clinical studies performed. Evidence consists of bench testing: ASTM F2554-18 accuracy testing, system accuracy testing (±2mm, ±1°) using Sawbones, cadaveric laboratory testing (±3mm, ±3°), and clinical workflow simulation using Sawbones and cadavers.

Technological Characteristics

Stereotaxic instrument; passive optical tracking technology; AC-powered computer platform/monitor; navigation software; surgical instruments (pointer, bone fixator). Accuracy: ±2mm translational, ±1° rotational. Software: Major level of concern. Standards: AS/NZS 3551:2012, IEC 60601-1-2:2014.

Indications for Use

Indicated for patients undergoing orthopaedic surgery (TKA or THA) where reference to rigid anatomical structures (pelvis, femur, tibia) can be identified. Suitable for conditions of knee or hip joints where computer-assisted surgery is appropriate.

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

Stryker OrthoMap Precision Knee System (K162341)
Stryker OrthoMap Versatile Hip System (K162937)

Reference Devices

BrainLAB DASH Knee (K102251)

Related Devices

K223927 — 360CAS · Kico Knee Innovation Company Pty Limited · Jan 27, 2023
K153396 — Aesculap OrthoPilot Next Generation · Aesculap Implant Systems, LLC · May 16, 2016
K080547 — ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 · Aesculap Implant System, Inc. · May 23, 2008
K162341 — Stryker OrthoMap Precision Knee system · Stryker Leibinger GmbH & Co KG · Oct 12, 2016
K060282 — TOTAL KNEE SURGETICS NAVIGATION SYSTEM · Praxim S.A · Apr 10, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 11, 2022 Kico Knee Innovation Company Pty Limited Stefanie Auf Der Mauer Head of RA/QA Suite 3, Building 1, 20 Bridge Street Pymble, New South Wales 2073 Australia Re: K213380 Trade/Device Name: 360cas Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 8, 2021 Received: October 13, 2021 #### Dear Stefanie Mauer: 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. {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K213380 Device Name 360CAS Indications for Use (Describe) The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures. The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified. The 360CAS Knee is indicated for the following surgical procedures: - Total Knee Arthroplasty (TKA) - For conditions of the knee joint in which the use of computer assisted surgery may be appropriate The 360CAS Hip is indicated for the following surgical procedures: - Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used - For conditions of the hip joint in which the use of computer assisted surgery may be appropriate | 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 is a logo for "360 Med Care". The logo features the number "360" in a bold, sans-serif font, with the words "MED CARE" stacked below it in a smaller font. The logo is encircled by a dotted line that transitions from black to blue to gray, suggesting a full circle or a comprehensive approach. The upper right portion of the circle is a solid gray arc with an arrow at the end, further emphasizing the "360" concept. # 510(k) Summary A 510(k) summary has been prepared in accordance with the requirements of 21 CFR 807.92 Content and Format of a 510(k) Summary. # Applicant Details | Name: | Kico Knee Innovation Company Pty Limited | |----------------------------------|-----------------------------------------------------------------------------------------| | Address: | Suite 3, Building 1, 20 Bridge Street Pymble, New South Wales 2073 Australia | | Contact Person / Prepared By: | Emma Hayes Regulatory Affairs Manager +64 221 188 373 (phone) emma@360med.care | | Date Prepared: | January 11, 2022 | # Device Details and Substantial Equivalence Claim | Device Common Name: | Orthopedic Stereotaxic Instrument | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Device Trade Name: | 360CAS | | Regulation Number: | 21 CFR 882.4560 | | Regulation Name: | Stereotaxic Instrument | | Regulatory Class: | II | | Panel: | Orthopedic | | Product Code: | OLO | | Predicate Devices: (Primaries for Knee and Hip) | Stryker OrthoMap Precision Knee System (K162341) Stryker OrthoMap Versatile Hip System (K162937) | {4}------------------------------------------------ ## Device Description The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map a patient's morphology, navigate surgical instruments and implants and assess the state of the joint throughout the surgery. The system consists of four main components: 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g. pointer, bone fixator(s)). #### Indications for Use The 360CAS is intended to be used as a planning and intraoperative quidance system to enable open or percutaneous image quided surgical procedures. The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified. The 360CAS Knee is indicated for the following surgical procedures: - Total Knee Arthroplasty (TKA) . - For conditions of the knee joint in which the use of computer . assisted surgery may be appropriate The 360CAS Hip is indicated for the following surgical procedures: - Total Hip Arthroplasty (THA) e.g., open or minimally invasive, . where a posterior or anterior approach is used - For conditions of the hip joint in which the use of computer assisted . surgery may be appropriate #### Performance Data The following performance data was provided in support of substantial equivalence decision: {5}------------------------------------------------ # Electrical Safety and Electromagnetic Compatibility (EMC) Testing Electrical safety and EMC testing were conducted on the subject device in accordance with the following standards: - AS/NZS 3551:2012 Management Programs for Medical Equipment . - IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests (FDA Recognition #: 19-8) #### Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was provided as recommended by: - Guidance for Industry and Food and Drug Administration Staff: ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued 11-May-2005 - Guidance for Industry and Food and Drug Administration Staff: Off-. the-Shelf Use in Medical Devices issued 27-Sep-2019 The 360CAS Navigation Software was considered as a "MAJOR" level of concern. ## Performance Testing - Bench The following design verification and validation activities have been performed to ensure the correct functionality of the system as it has been specified : - . ASTM accuracy testing verifying the accuracy performance of the spatial tracking technology using the standardized test procedure according to ASTM F2554-18. - . System accuracy testing verifying the specified accuracy of ±2mm and ±1º using Sawbones mimicking patient's anatomy. - . Clinical accuracy testing verifying the specified accuracy of ±3mm and ±3º in a cadaveric laboratory. - . Clinical workflow verifying that all system components (application, computer platform and accessories) are compatible. Complete knee and hip arthroplasty procedures were simulated using Sawbones mimicking the patient's anatomy and cadaver laboratory. - Functional testing to ensure that all functional requirements are . fulfilled. {6}------------------------------------------------ - Safety testing verifying the effectiveness of all risk controls . determined in the device risk analysis. This strategy ensures the verification of the accuracy, system integration, software algorithms, system functionality, and correct implementation of the risk control measures. All tests have been successfully completed. #### Animal Study No animal studies were performed to support substantial equivalence. #### Clinical Studies No clinical studies were performed to support substantial equivalence. #### Substantial Equivalence Rationale - 360CAS Knee The 360CAS Knee is considered substantially equivalent to the Stryker OrthoMap Precision Knee System regarding clinical, technical, and biological characteristics. The 360CAS Knee and the Stryker OrthoMap Precision Knee System are both intended to be used as planning and intraoperative quidance systems to enable open and percutaneous surqical procedures. Both systems are indicated for knee conditions where the use of CAS is appropriate (e.q., TKA) and where reference to a rigid anatomical structure can be identified. The 360CAS Knee and the Stryker OrthoMap Precision Knee System are intended to be used by trained orthopaedic surqeons and operators in an equivalent fashion, following equivalent registration and navigation workflows. Both systems comprise equivalent components (computer platform, navigation software, instruments, tracking components) to achieve the same purpose. The 360CAS Knee and Stryker OrthoMap Precision Knee System both require AC power to power the computer, monitor and camera. The Stryker OrthoMap Precision Knee System requires additional external enerqy sources (batteries) to power their smart instruments, whereas the 360CAS Knee does not require additional external energy sources for its instruments. Both systems use optical tracking technology where a tracker is sensed by a camera to compute spatial information. Surgical navigation in both systems is enabled through similar software platforms developed by each manufacturer. The 360CAS Knee passive optical trackers and instruments do not require infrared (IR), wireless connection or external energy sources for operation. Such passive instruments are commonly used and have been successfully integrated in other marketed devices such as the K102251 BrainLAB DASH Knee. The 360CAS Knee and the Stryker OrthoMap Precision Knee System are measuring devices {7}------------------------------------------------ with identical accuracy of ±2 mm and ±1°. Therefore, it is concluded that the 360CAS Knee is substantially equivalent to the Stryker OrthoMap Precision Knee System. | Characteristic | 360CAS Knee (Subject Device) | Stryker OrthoMap Precision Knee System (Predicate Device) | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | 360CAS Knee | Stryker OrthoMap Precision Knee System | | 510(k) Submitter: | Kico Knee Innovation Company Pty Limited | Stryker Leibinger GmbH & Co. KG | | 510(k) Number: | K213380 | K162341 | | Regulation Number: | 882.4560 – Stereotaxic Instrument | 882.4560 – Stereotaxic Instrument | | Product Code: | OLO | OLO | | Product Class: | II | II | | Indications for Use | The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures. The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified. The 360CAS Knee is indicated for the following surgical procedures: • Total Knee Arthroplasty (TKA) • For conditions of the knee joint in which the | The Stryker OrthoMap Precision Knee system, which is comprised of the OrthoMap Precision Knee 5.0 software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate. | | Characteristic | 360CAS Knee (Subject Device) | Stryker OrthoMap Precision Knee System (Predicate Device) | | | use of computer assisted surgery may be appropriate | | | Anatomy | Knee | Knee | | Patient Population | Patients with medical conditions where use of computer-assisted surgery may be appropriate. | Patients with conditions of the knee joint where use of computer-assisted surgery may be appropriate. | | End-Users | Trained orthopaedic surgeon and system operators | Trained orthopaedic surgeon and system operators | | Clinical Workflow | Clinical workflow testing verifying that all system components are compatible. Complete total knee arthroplasty procedures are simulated using Sawbones mimicking the patient's anatomy and cadaver laboratory. | Clinical workflow testing verifying that all system components (application, computer platform and accessories) are compatible. Complete total knee arthroplasty procedures are simulated using Sawbones mimicking the patient's anatomy. | | Main System Components | Computer Platform Navigation Cart 360CAS Navigation Software - 360CAS Knee Surgical Instruments Spatial Tracking Components | Computer Platform OrthoMap Precision Knee 5.0 Software Smart Instruments Patient Tracker Fixation Navigated Manual Instruments Instrument Battery, Trays | | Energy Source | Computer - AC Power | Computer - AC Power Smart Instruments – Battery 1. Pointer 2. nGenius® Tibia Tracker | | Characteristic | 360CAS Knee (Subject Device) | Stryker OrthoMap Precision Knee System (Predicate Device) | | | | 3. nGenius® Femur Tracker | | Tracking Technology | Passive optical tracking technology | Infrared optical active sensing technology: Infrared light emitted by diodes placed in a known fashion on navigated surgical instruments is sensed by a camera array (navigation camera) on the computer platform, thus allowing for computation of the spatial information. | | Image Display | Monitor | Monitor | | System Accuracy | The system enables the determination of the mechanical axes of the lower limb as well as cut and component alignment with a mean translational error of < $±2$ mm and a mean rotational error of < $±1$ °. | The system enables the determination of the mechanical axes of the lower limb as well as cut and component alignment with a mean translational error of < $±2$ mm and a mean rotational error of < $±1$ °. | | Software | 360CAS Navigation Software - 360CAS Knee | OrthoMap Precision Knee 5.0 Software | | Patient / Instrument Trackers | Patient/Instrument Trackers • Femur Tracker • Tibia Tracker • Resection Guide Tool Pointer • Pointer | Patient/Instrument Trackers • Universal Tracker • Tibia/Pelvic Tracker • Femoral Tracker • nGenius Universal Tracker • nGenius Tibial Tracker • nGenius Femur Tracker • Hip Femur Tracker | | Characteristic | 360CAS Knee (Subject Device) | Stryker OrthoMap Precision Knee System (Predicate Device) | | Patient Tracker Fixation | Bone Fixator | Hip Tibia/Pelvis Tracker Pointers Pointer, Knee Navigation Ortho Grip Knee Pointer OrthoLock with OrthoLock Navigation Pin or OrthoLock EX-Pins Anchoring Pins and Insertion Tool | | Navigated Manual Instruments | Resection Guide Tool The resection tool is capable of being used with any manufacturers cutting blocks. The resection guide tool is compatible with 1.3mm thick saw blades. | Dedicated Mini Jig (which consists of): Adjustment Component Tracker Adapter Mini Cutting Guide Mini Fixation Plate MIS Jig (which consists of): Navigated MIS Jig-A Navigated MIS Jig-B Tracker Adapter Plane Probes (Resection Plan Probes and a Posterior Plane Probe) | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ## Substantial Equivalence Rationale - 360CAS Hip The 360CAS Hip is considered substantially equivalent to the Stryker OrthoMap Versatile Hip System regarding clinical, technical and biological characteristics. The 360CAS and the Stryker OrthoMap Versatile Hip System are both intended to be used as planning and intraoperative guidance systems to enable open and percutaneous surgical procedures. Both systems are indicated for hip conditions where the use of CAS is appropriate (e.q., THA) and reference to a rigid anatomical structure can be identified. The 360CAS Hip and the Stryker OrthoMap Versatile Hip System are intended to be used by trained orthopaedic surgeons and operators in an equivalent fashion, following equivalent registration and navigation workflows. Both systems comprise equivalent components (computer platform, navigation software, instruments, tracking components) to achieve the same purpose. The 360CAS Hip and Stryker OrthoMap Versatile Hip System both require AC power to power the computer, monitor and camera. The Stryker OrthoMap Versatile Hip System requires additional external energy sources (batteries) to power smart instruments, whereas the 360CAS Hip does not require additional external energy sources for its instruments. Both systems use optical tracking technology where a tracker is sensed by a camera to compute spatial information. The 360CAS Hip passive optical trackers and instruments do not require infrared (IR), wireless connection or external energy sources for operation. Such passive instruments are commonly used and have been successfully integrated in other marketed devices such as the K102251 BrainLAB DASH Knee. Surgical navigation in both systems is enabled through similar software platforms developed by each manufacturer. The 360CAS Hip and the Stryker OrthoMap Versatile Hip System are measuring devices where the 360CAS Hip provides greater accuracy of with mean translational error of <±2 mm and mean rotational error of <±1°. Therefore, it is concluded that the 360CAS Hip is substantially equivalent to the Stryker OrthoMap Versatile Hip System. | Characteristic | 360CAS Hip (Subject device) | Stryker OrthoMap Versatile Hip System (Predicate device) | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | 360CAS Hip | Stryker OrthoMap Versatile Hip System | | Characteristic | 360CAS Hip (Subject device) | Stryker OrthoMap Versatile Hip System (Predicate device) | | 510(k) Submitter: | Kico Knee Innovation Company Pty Limited | Stryker Leibinger GmbH & Co. KG | | 510(k) Number: | K213380 | K162937 | | Regulation Number: | 882.4560 - Stereotaxic Instrument | 882.4560 - Stereotaxic Instrument | | Product Code: | OLO | OLO | | Product Class: | II | II | | Indications for Use | The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures. The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified. The 360CAS Hip is indicated for the following surgical procedures: Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is usedFor conditions of the hip joint in which the use of computer assisted surgery may be appropriate | The Stryker OrthoMap Versatile Hip System, which is comprised of the OrthoMap Versatile Hip 2.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified. The system is indicated for conditions of the hip joint in which the use of image guided surgery may be appropriate. The Stryker OrthoMap Versatile Hip system is indicated for the following surgical procedures: Total Hip Athroplasty (THA), e.g. open or minimally- invasivePrecisely position instruments, implants and bony tissue during | | Characteristic | 360CAS Hip (Subject device) | Stryker OrthoMap Versatile Hip System (Predicate device) | | | | • Revisions. | | Anatomy | Hip | Hip | | Patient Population | Patients with conditions of the hip joint where use of computer-assisted surgery may be appropriate. | Patients with conditions of the hip joint where use of computer-assisted surgery may be appropriate. | | End-Users | Trained orthopaedic surgeons and system operators | Trained orthopaedic surgeons and system operators | | Clinical Workflow | Clinical workflow testing verifying that all system components are compatible. Complete total hip arthroplasty procedures are simulated using Sawbones mimicking the patient's anatomy and cadaver laboratory. | Clinical workflow testing verifying that all system components (application, computer platform and accessories) are compatible. Complete total hip arthroplasty procedures are simulated using Sawbones mimicking the patient's anatomy. | | Main System components | Computer Platform Navigation Cart 360CAS Navigation Software - 360CAS Hip | Computer Platform OrthoMap Versatile Hip 2.0 Software | | | Surgical Instruments | Smart Instruments Patient Tracker Fixation Navigated Manual Instruments | | | Spatial Tracking Components | Instrument Battery, Trays | | |…