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Found 889 results
510(k) Data Aggregation
(199 days)
H3C 2N6
Canada
Re: K251314
Trade/Device Name: Rosa® Knee System
Regulation Number: 21 CFR 882.4560
Name: ROSA® Knee System
Classification Name:
- OLO – Orthopedic Stereotaxic Instrument (21 CFR 882.4560
The ROSA Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for total knee replacement surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan optionally determined pre-operatively using compatible X-ray based surgical planning tools. It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.
The ROSA Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System.
The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona® PPS® CR, Persona® PPS® PS, Persona SoluTion PPS, Persona IQ® The Smart Knee™, Vanguard® CR, and Vanguard PS.
The ROSA® Knee System for use with the ROSA® RECON platform is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.
The ROSA® Knee System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® RECON Platform before surgeries.
If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI system (X-PSI Knee System K171269) to create a 3D model of the patient's femur/tibia and allows the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks.
The intraoperative workflow and surgical concepts implemented in the ROSA Knee System remain close to the conventional TKA workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) Determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.
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(110 days)
Prepared:** 11/10/2025
Classifications: 21 CFR §888.3075, Posterior cervical screw system
21 CFR §882.4560
Prepared:** 11/10/2025
Classifications: 21 CFR §888.3075, Posterior cervical screw system
21 CFR §882.4560
The CMORE® CT System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In patients requiring adjuvant radiotherapy following spinal stabilization, metal markers at the screw tips can be used as fiducial markers in radiotherapy treatments (e.g., SBRT, proton therapy).
The CMORE® CT System is intended to provide immobilization and stabilization of spinal segments with anterior interbody support implanted at the same spinal level/s as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):
- Traumatic spinal fractures and/or traumatic dislocations
- Instability or deformity
- Failed previous fusions (e.g. pseudarthrosis)
- Degenerative disease, including intractable radiculopathy and/or myelopathy
- Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
- Degenerative disease of the facets with instability
- Patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.
The CMORE® CT System is intended to be used with anterior interbody support implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The CMORE® CT System may be connected to the VADER® Pedicle System using connectors.
CMORE® CT System Navigated Instruments
CMORE® CT System Navigated Instruments are intended to be used during the preparation and placement of the CMORE® CT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic StealthStation® and Brainlab Navigation Systems which are indicated for any medical condition in which the use of stereotactic surgery may by 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 of anatomy.
CMORE® CT System
The CMORE® CT System is a posterior cervical fixation system intended to provide structural stability and mechanical support to the cervical and upper thoracic spine. The CMORE® CT System is manufactured from Carbon/PEEK using a proprietary manufacturing process and is comprised of screws, rods, nut screws, and connectors as well as corresponding instruments.
CMORE® CT System System Navigated Instruments
The CMORE® CT System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared spinal bone screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed to be used with the Medtronic StealthStation® and Brainlab Navigation Systems. The instruments include awls, drills, probes, taps, drivers, and adapters.
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(250 days)
California 19403
Re: K250599
Trade/Device Name: ExcelsiusGPS™ Instruments
Regulation Number: 21 CFR 882.4560
Instruments
Common Name: Navigated instruments
Classification: Per 21 CFR as follows:
§882.4560
Instruments
Common Name: Navigated instruments
Classification: Per 21 CFR as follows:
§882.4560
ExcelsiusGPS™
ExcelsiusGPS™ 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 compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
ExcelsiusHub™
ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
Subject ExcelsiusGPS™ instruments consist of verification adapters and surgical instruments, including interbody inserters and trials, that may be used manually or navigated with the use of ExcelsiusGPS™ or ExcelsiusHub™. The surgical instruments are used to prepare the implant site or implant the device. Instruments are non-sterile and reusable.
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(121 days)
Re: K252088**
Trade/Device Name: Firebird SI Navigation System
Regulation Number: 21 CFR 882.4560
Name(s):** Stereotaxic Instrument
Device Class: Class II
Regulation Number(s): 21 CFR § 882.4560
The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, 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 or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Firebird SI Navigation System consists of manual, surgical instruments for use with the Medtronic StealthStation Navigation System via the NavLock Tracker and SureTrak II Large Passive Fighter to assist surgeons in locating anatomical structures in minimally invasive and open procedures for preparation and placement of Firebird SI Fusion System implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The Firebird SI Navigation System instruments are manufactured from Stainless Steel per ASTM F899 or ASTM A564.
The Firebird SI Navigation System instruments include the following:
- Screw Driver
- Drills
- MDT Inline Adapter
The Firebird SI Navigation System instruments are to be used with the following FDA cleared SeaSpine Spinal System:
- Firebird SI Fusion System
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(61 days)
Pennsylvania 18017
Re: K252742
Trade/Device Name: Navigated Instruments
Regulation Number: 21 CFR 882.4560
Stereotaxic instrument |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Regulation Number | 882.4560
The Navigated Instruments are intended to be used during preparation and placement of Medtronic Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
The Navigated Instruments are specifically designed for use with the Medtronic StealthStation™ System, 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 of the anatomy.
The Navigated Instruments are spine preparation instruments made of surgical grade stainless steel per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. When used with the appropriate Medtronic single-use sterile spheres the subject devices can be used as navigated surgical instruments with the Medtronic StealthStation™ System (Medtronic computer-assisted surgery system) to track the instruments in the surgical field.
Specialized cases and trays are available for optional use with the Navigated Instruments. They are manufactured from stainless steel per ASTM F899, aluminum per ASTM B209, and silicone. Ancillary non-navigated instrumentation is available for optional use with the Navigated Instruments. These instruments are not specifically intended to be used with the subject device.
The Navigated Instruments are provided non-sterile.
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(248 days)
K250520**
Trade/Device Name: OsteoCentric Navigated Instruments System
Regulation Number: 21 CFR 882.4560
Name:** Orthopedic Stereotaxic Instruments
Classification & Regulation #: Class II per 21 CFR §882.4560
The OsteoCentric Navigated Instruments are intended to be used during the preparation and placement of OsteoCentric Pedicle Fasteners during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The OsteoCentric Navigated Instruments are specifically designed for use with the Medtronic StealthStation® System, 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.
The OsteoCentric Navigated Instruments System is a set of reusable surgical instruments for use with the Medtronic® StealthStation™ S8 Navigation System to assist surgeons in precisely locating anatomical structures in either open or percutaneous procedures for the placement of pedicle screws. The OsteoCentric Navigated Instruments are intended for use with the OsteoCentric Pedicle Fasteners Additionally, the submission includes a hybrid technique for placement of the Integrity SI® Fusion implants.
The OsteoCentric Navigation Instrument System includes navigated probes, taps, drills, and drivers and are manufactured from medical grade stainless steels per ASTM F899, ASTM F276, and ASTM F138.
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(29 days)
Implants: Class II, Instruments: Class II
Product Codes: Implants: NKG (888.3075), Instruments: OLO (882.4560
Infinity™ OCT System
The Infinity™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
- Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- Failed previous fusions (e.g. pseudarthrosis).
- Tumors involving the cervical spine.
- Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System and PASS OCT Spinal System package insert for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Infinity™ OCT System
The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.
The Infinity™ OCT System is fabricated from medical grade titanium alloy and medical grade cobalt chromium.
Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems
Medtronic Navigated Reusable Instruments are spine preparation instruments manufactured from high grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. These instruments are also compatible with Medtronic's IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver.
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(85 days)
Product Code** | NKBKWP, OLO, OUR |
| CFR Section | 21 CFR section 888.3070, 888.3050, 888.3010, 882.4560
Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques.
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
S2AI Screws: The OLYMPIC Posterior Spinal Fixation System S2AI Screw System is intended for sacroiliac joint fusion for the following conditions:
- Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to OLYMPIC posterior rods the OLYMPIC S2AI Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- Spondylolisthesis
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Spinal tumor
- Pseudarthrosis
- Failed previous fusion
Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
S2AI Screws: The MASADA Modular Spinal Fixation System S2AI Screw System is intended for sacroiliac joint fusion for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to MASADA posterior rods the MASADA S2AI Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kypohosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion
Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system.
The MASADA Modular Spinal Fixation System S2AI Screw System consist of an assortment of implants in various lengths and diameters, and associated instrument sets for both Open and minimally invasive (MIS) approaches. The S2AI bone screw implant component made from Titanium alloy (Ti-6Al-4V-ELI) as described by ASTM F136. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and provide foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the Iliac trajectories. Additionally, the MASADA S2AI Screw System can be placed into the S1 pedicle. It is designed for connection to the MASADA Pedicle Screw System 5.5mm or 6.0mm diameter titanium alloy or cobalt chrome alloy spinal fixation rods.
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(846 days)
10010
Re: K231897
Trade/Device Name: NeuroAlign software
Regulation Number: 21 CFR 882.4560
10010
Re: K231897
Trade/Device Name: NeuroAlign software
Regulation Number: 21 CFR 882.4560
| Device Common Name: | Neurological Stereotaxic Instrument |
| Device Regulation & Name: | 21 CFR 882.4560
The Medivis NeuroAlign device is stereotaxic image guidance system intended to be used with the Microsoft HoloLens headset for the spatial positioning and orientation of neurosurgical instruments employed by surgeons. This device is specifically intended for cranial surgery, where reference to a rigid anatomical structure can be identified, without the need for a frame or fixation of a navigated instrument guide to the patient. The system is intended for use in various surgical settings, including operating rooms, intensive care units, and interventional procedure suites.
The Medivis NeuroAlign device is a software application that processes and visualizes anatomical images for surgical navigation. It works in conjunction with off-the-shelf hardware and surgical instruments, including an IGS workstation, touchscreen monitor, and a 3D tracking system, along with IR trackable surgical instruments. The device uses pre-acquired patient data, which can be transferred from the hospital's PACS or local files. It operates with a network-based software interface for data downloading and supports image upload for custom visualization. The device's data transfer is unidirectional. It provides various image display options and manipulation features, primarily controlled through the touchscreen monitor. An HMD serves as an adjunct heads-up display and functions as an optical 3D tracking component for patient and surgical tool localization. The device registers patient data to the surgical environment through IR tracking, but it does not overlay data onto the surgical site. It cannot integrate with intra-operative image sources like surgical microscopes or ultrasound devices.
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(176 days)
K251282**
Trade/Device Name: StealthStation™ S8 Spine Software v2.1
Regulation Number: 21 CFR 882.4560
Classification Name:
Stereotaxic Instrument (21 CFR 882.4560)
V.
The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures in adult and skeletally mature pediatric (adolescent) patients. Their use 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 the spine or pelvis, can be identified relative to images of the anatomy.
This can include the following spinal implant procedures in adult patients, such as:
- Pedicle Screw Placement
- Iliosacral Screw Placement
- Interbody Device Placement
This can include the following spinal implant procedures in skeletally mature pediatric (adolescent) patients:
- Pedicle Screw Placement
StealthStation S8 Spine Software helps guide surgeons during spine surgical procedures. The subject software works in conjunction with a navigation system, surgical instruments, a referencing system, and computer hardware. Navigation tracks the position of instruments in relation to the surgical anatomy and identifies this position on pre-operative or intraoperative images of the patient. The mouse, keyboard, touchscreen monitor, and footswitch of the StealthStation platforms are used to move through the software workflow. Patient images are displayed by the software from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display on the monitor. The surgeon may also create and store one or more surgical plan trajectories before and during surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory.
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