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The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System. The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications: - Enovis™ EMPOWR Knee System® - Ortho Development BKS® and BKS TriMax® Knee System - Total Joint Orthopedics Klassic® Knee System - United U2™ Knee Total Knee System - Medacta® GMK® Sphere / SpheriKA Knee Systems - Zimmer Biomet Anterior & Posterior Referencing Persona® Knee - b-ONE MOBIO® Total Knee System - Maxx Orthopedics Freedom® Total & Titan Knee - LINK® LinkSymphoKnee System

The TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN® Planning Station) including THINK Case Manager (TCM) the web-based method for surgeons to review, approve and download approved surgical plans, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool. The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively using TNav.

The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system instruments. Current cleared Spineart® Navigation reusable instruments (K241644, K210472 & K183630) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's Brainlab® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the Brainlab® Spine & Trauma Navigation System to the cleared range of SPINEART® Navigation Instrument System.

**Stealth™ Spine Clamps** When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable: - The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. - The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. - The Stealth™ spine clamps are indicated for skeletally mature patients. **ModuLeX™ Shank Mounts** When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable: - The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. - The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. - The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery. - The ModuLeX™ shank mounts are indicated for skeletally mature patients.

The Stealth™ Spine Clamps are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable. The ModuLeX™ Shank Mounts are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories. The Paradigm System is used with an external monitor.

The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.

The subject devices, Image calibrator-21F and Image calibrator-31F are designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The subject devices are modified from previously cleared devices to be compatible with the 21 cm/ 31 cm flat panel C-arm for CT image position and calibration. The software upgrade is due to these newly added Image calibrators and one added function of auto-labeling for CT/C-arm image registration.

OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform. The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a system generated model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position. The system is designed for orthopedic surgical procedures including: - Pre-operative planning of total hip arthroplasty (THA) - Intraoperative navigated surgery for THA using a posterior approach

OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery. The OTS Hip device is a modified device from the company's previously cleared OTS Hip (K232140). OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system. The system uses medical imaging data in DICOM format that is loaded into the system for access in the software that are part of the system. OTS Hip software consists of OTS Hip Plan (OHP), which is a 3D preoperative planning software, and OTS Hip Guide (OHG) that provides intraoperative real-time navigation for the guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal positions. OHP is a software for preoperative planning prior to a THA (Total Hip Arthroplasty) surgery. OHP enables the orthopedic surgeon to prepare surgery by analyzing the patient anatomy in a 3D environment based on medical imaging data. OHG imports the result from the preceding planning stage, a released plan, with the 3D model and planned data, from the database of the OTS system. In addition, OHG monitors the real-time information of the position of instruments and prosthetic components in a 3D environment by means of medical imaging data. The components of the OHG device include a camera and computer stand with an electrical system to which a camera and a medical panel PC are attached, a footswitch, a keyboard, Tracers (passive markers), adapters that hold the Tracers and can be mounted to compatible surgical instruments and that are used for calibration, and tools and instruments that are used during surgery. The OTS Hip is compatible with the following components: - PINN GB OFFSET GRATER HANDLE, DePuy Synthes 2550-00-100 - Emphasys offset reamer, DePuy Synthes 4811-00-510 - Greatbatch Offset Cup Impactor, DePuy Synthes 2550-00-115 - Pinnacle straight impactor, DePuy Synthes 2217-50-041 - Emphasys straight impactor, DePuy Synthes 4812-00-150 - Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-002 (long) - Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-012 (short) - Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-001 (long) - Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-012 (short)

The Altus Spine Navigation System reusable instruments are indicated to be used during the preparation and placement of Altus Spine Valencia Pedicle Screw System and Altus Spine Monaco Pedicle Screw System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Altus Spine Navigation System reusable instruments are specifically designed for use with the Medtronic StealthStation® System S8, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. • For a comprehensive summary of indications, the IFU for the specific system of use must be directly referenced: Altus Spine Valencia Pedicle Screw System / Altus Spine Monaco Pedicle Screw System. The Altus Spine Navigation System is intended to pair with either the Altus Spine Valencia Pedicle Screw System or Altus Spine Monaco Pedicle Screw system to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The Altus Spine Navigation system may be used for noncervical pedicle fixation via posterior percutaneous approach with MIS instrumentation.

The Altus Spine Navigation System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The Altus Spine Navigation System includes the following instruments dedicated to screw placement: Screwdrivers and Taps. The Altus Spine Navigation System is to be used with the following Altus Spine Systems: ▪ Altus Spine Valencia Pedicle Screw System ▪ Altus Spine Monaco Pedicle Screw System All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided non sterile. The Altus Spine Navigation System instruments are not compatible with implants from other manufacturers. The Altus Spine Navigation System are designed for use only with Medtronic StealthStation® System S8 (V2.1.0) and the Medtronic NavLock® Tracker System.

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Total Knee Arthroplasty (TKA). The implant systems compatible with the system: Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary); Triathlon Total Knee System (TS inserts cemented primary).

The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a camera, a computer, dedicated instrumentation, an operating software, and tools and accessories. The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement, and interpretive/intraoperative navigation of the patient's anatomy. Once configured for a specific application, the Mako robotic arm can serve as the surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The Dynamis Robotic Surgical System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on intraoperative CT scans. The Dynamis Robotic Surgical System is indicated for the placement of non-cervical spinal pedicle screws.

The Dynamis System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include thoracic, lumbar, and sacral approaches. Dynamis is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans. The system is indicated for the placement of non-cervical spinal pedicle screws and is intended for use with any legally marketed spinal system that contains instruments meeting the criteria for use with the Dynacan end effectors of the Dynamis System. The Dynamis System is comprised of two computer-controlled robotic arms to support surgical robotic guidance, while a third robotic arm holds and controls the Scout navigation camera. All components are integrated into one physical cart located partially underneath the surgical table. The Dynamis Robotic Surgical System functions as a stable platform that operates with intraoperative DICOM format images for intraoperative planning and operation. The system software is responsible for all motion, control, navigation, data storage, user management, case management, and safety functions. The navigation and guidance system establishes registration between the virtual patient (points on the patient images) and the physical patient (corresponding to the patient's bony anatomy). The information of the plan, coupled with the registration, provides the necessary information to give visual assistance to the surgeon during freehand navigation or during the robotic alignment of instruments. Navigation can also be achieved without robotic guidance with the proprietary navigation instruments provided with the Dynamis system. Dynamis is designed and intended to be used with qualified surgical instruments, which are defined as legally marketed instruments that meet pre-specified criteria and that pass the Instrument Setup process, which is an instrument verification test integrated into the Dynamis Robotic Surgical System. To qualify a surgical instrument for use through the Dynacan, it must be legally marketed and meet the following criteria: - Round - Straight - Rigid - Concentric In addition, the user must accurately measure the effective length of the instruments using the Dynamis system during the set-up phase. The navigation-based robotic capabilities of Dynamis are intended for use with a variety of legally marketed, qualified surgical implantation instruments, as the adjustable end effector (Dynacan) is able to mechanically support a wide range of device diameters from 3 mm to 20 mm in diameter, including legally marketed taps and screwdrivers which can be checked and qualified by the user implementing the Dynamis Instrument Setup.