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The SternalPlate System is indicated for use in stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion.

This Special 510(k) is submitted to evaluate the modifications to the Predicate Device plates resulting in the Subject Device plates. There have been no changes to the previously cleared plates and screws cleared in K183172, this submission is only for the addition of the four new Subject Device plates. The four Subject Device plates include T-Plates and Transverse Plates. Both Subject Device variants, the T-Plates and Transverse Plates, are geometrically derived from the following Predicate Device plates: the Ladder Plate Narrow (Reff/ 4740006) and the Straight 24-hole Plate (Ref# 4740012). The Subject Device plates therefore have the same features, the same tolerances, and are made from the same material as the Predicate Device plates. Furthermore, the Subject Device plates are manufactured with the same manufacturing process as the Predicate Device plates.

The Q Guidance System, when used with the Spine Guidance 5.2 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified. The system assists in the positioning of instruments for procedures on the pelvis and spine, including: · Screw and Needle Placement in the spine or pelvis · Bone resection in the spine The Mako Spine System is intended to be used as an accessory to the Stryker Spine Guidance System. It is intended to be used to facilitate preparation and placement of screws of Stryker Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients. The Mako Spine System is intended to be used as part of the Stryker Spine Guidance System, which is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the spine or pelvis can be identified. The Stryker System 8 Dual Trigger Rotary Battery Powered Heavy Duty System is intended for use in the drilling, reaming, and decorticating of bone and other bone related tissue in a variety of surgical procedures. They are also usable in the placement of screws, wires, pins, and other fixation devices. The Stryker System 8 Dual Trigger Rotary Battery Powered Heavy Duty System, when used in conjunction with Stryker Spine Guidance Software, is intended to be used to facilitate preparation and placement of screws of Stryker Spine implant systems in adult and pediatric (adolescent) patients.

The Spine Guidance System is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery on the spine and pelvis. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery. The system is comprised of the Spine Guidance 5.2 Software, Q Guidance System (computer platform), Mako Spine System, navigated accessories/ instruments (e.g., patient/ instrument trackers, pointers), and various system components (e.g., trackers, calibration instruments, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies as well as haptic trajectory guidance to facilitate pedicle preparation and screw placement using Mako Spine System. The Spine Guidance 5.2 Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via wireless optical tracking technology. The software provides the functions to perform the indicated navigated spine surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated spine surgical procedures. The Mako Spine System is an accessory to the subject Spine Guidance 5.2 (SG5.2) Software and extends the functionality of the SG5.2 Software to provide trajectory guidance to align the End Effector tube with a pre-planned screw trajectory to facilitate preparation and placement of screws in the non-cervical spine. The Mako Spine System includes a Mako 3.5 Robotic arm, new dedicated instrumentations (i.e. Spine Pedicle End Effector, Spine Pedicle Registration Tool, Pedicle Instruments, etc.), and previously cleared compatible instruments (i.e. Vizadisc, Rio System Quick Connect Base Array, End Effector Tracker Array, Calibration End-Effector, etc.). Mako 3.5 Robotic Arm is connected to the existing Q Guidance System (K233542) via Mako ethernet cable. The System 8 Dual Trigger Rotary Handpiece is used in the drilling, reaming, and decorticating of bone and other bone related tissue in a variety of surgical procedures. It is also used in the placement of screws, wires, pins, and other fixation devices. The handpiece, when used with a compatible instrument tracker, can be used with the Spine Guidance 5.2 Software to facilitate preparation and placement of screws using Stryker Spine implant systems.

Universal CMF System Intended use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for use Craniomaxillofacial Implants The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Mandible Implants The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. MP Lefort I Plates Intended Use The Stryker Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Indications for Use The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy, stabilization, and rigid fixation of LeFort I fractures of the maxillofacial skeleton. Stryker Upper-Face AXS Screws And Mid-Face AXS Screws Indications for Use The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Stryker MP, Mandible, HMMF And MMF AXS Screws -Universal CMF System: Intended Use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for Use Craniomaxillofacial Implants The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Mandible Implants The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. -Stryker Universal SMARTLock Hybrid MMF System: Intended Use The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing. Indications for Use The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. -Stryker MMF Screw Intended use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. Indications for use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. Stryker Universal Orbital Floor System Intended Use The Stryker Universal Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit. Indications for Use The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older. Stryker Universal Smartlock Hybrid MMF System Intended use The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing. Indications for use The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. Stryker MMF Screw Intended use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. Indications for use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

This Bundled. Traditional 510(k) is for a single change the MR status that affects multiple devices and can be assessed during one review. There are no changes to the predicate devices themselves, just the addition to allow MR Conditional use of the implants in scope after MRI compatibility testing was completed. Associated labeling for each Predicate Device is also updated to reflect the MR conditional use of the implants.

The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified. The system assists in the positioning of instruments for procedures on the pelvis and spine, including: • Screw and Needle placement in the spine or pelvis.

The Spine Guidance 5.0 system is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery. The system is comprised of the Spine Guidance 5.0 Software, the Q Guidance System (computer platform), navigated accessories/ instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adaptors, patient/ instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.0 software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices.

Ortho Guidance Precision Knee Software: The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative quidance system to enable open computer-assisted surgerv. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. Ortho Guidance Express Knee Software: The Stryker quidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. Ortho Guidance Versatile Hip Software: The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems 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 systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate. The system is indicated for the following surgical procedures: - Total Hip Arthroplasty (THA) - Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery - Revisions Q Guidance System: The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified.

The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.

The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients. The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction, and can be used in pediatric patients older than 29 days and up to two (2) years of age (infants).

The Stryker Resorbable Fixation System (also referred to as Delta System or Stryker Delta Resorbable Fixation System; marketed as DualStart) is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The reference device can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes, and screws made of a copolymer of poly lactide and poly glycolide. Through this submission there is no change to the existing articles within the Delta System. The scope of this submission covers the addition of screws to the Delta System, which are shown as a modification of screws of the reference device to create the addition of self-tapping screws (STS) and low profile emergency screws (LPES). The subject STS and LPES, only, have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants).

Dental The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the maxillofacial and midfacial skeleton affected by trauma or for reconstruction, and can be used in pediatric patients older than 29 days and up to two (2) years of age (infants). The self-tapping screws and low profile emergency screws are designed to be compatible with the components (plates, meshes) of the Delta Resorbable Fixation System K213777.

The subject devices, the Delta System self-tapping screw (STS) and low profile emergency screw (LPES), are intended for use in the fixation of bones of the maxillofacial and midfacial skeleton, affected by trauma or for reconstruction. The subject device can be used in pediatric patients older than 29 days and up to two (2) years of age (infants), but is not intended for use in the mandible and/or full load bearing procedures. The scope of this submission covers the addition of the subject device screws to the previously cleared Delta System. Through this submission there is no change to the existing articles within the Delta System. The subject device screws are designed to be compatible with the existing components of the Delta System (plates, meshes), which have been previously cleared through K213777. Compared to the original Delta System, the subject STS and LPES have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants).

Ortho Guidance Precision Knee Software: The Stryker Ortho Q Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted 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. Ortho Guidance Express Knee Software: TThe Stryker Ortho Q Guidance System, with the Ortho Guidance Express Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted 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. Ortho Guidance Versatile Hip Software: The Stryker Ortho Q Guidance System, with the Ortho Guidance Versatile Hip Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted 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 computer-assisted surgery may be appropriate. The system is indicated for the following surgical procedures: - Total hip arthroplasty (THA) - Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery - Revisions Ortho Q Guidance System: The Stryker Ortho Q Guidance System is intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.

The purpose of this Traditional 510(k) submission is to seek clearance for 3 new software applications and 1 new guidance system. The applications have been created for functionality on the new guidance system in scope of this submission. The subject devices in scope of this submission are outlined in Table 6-1 with the predicate information in Table 6-2. The devices in scope of this submission, Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the Ortho Q Guidance System work within an ecosystem with a host of other existing smart devices and accessories that will be demonstrated to be compatible with the subject devices but are not in scope of this submission. The Ortho Guidance Precision Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Precision Knee System. The Ortho Guidance Express Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Express Knee System. The Ortho Guidance Versatile Hip Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Versatile Hip System. The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.