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510(k) Data Aggregation
(149 days)
The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
The GMK 3D Metal® Tibial Baseplate is indicated for cementless or cemented application if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- Collagen disorders, and avascular necrosis of the femoral condyle
- Post traumatic loss of joint configuration
- Primary implantation failure
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.
It is not possible to implant tibial wedges and extension stems with the GMK 3D Metal® Tibial Baseplate.
Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment
GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- Collagen disorders, and/or avascular necrosis of the femoral condyle
- Moderate valgus, varus, or flexion deformities
The subject devices are sterile, single use, individually packaged implants designed for cementless or cemented use in Total Knee Arthroplasty procedures.
The GMK 3D Metal Tibial Tray Extension is available in eleven sizes plus two bridge versions with right and left configuration.
Analogously to the predicate devices, the subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.
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(336 days)
• Reverse Shoulder Prosthesis
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The Reverse Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
• Anatomic Shoulder Prosthesis
The Medacta Anatomic Shoulder Prosthesis is intended for use as a hemi or total shoulder replacement for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use.
The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.
• Reverse Shoulder Prosthesis – monobloc stem
The reverse shoulder prosthesis using the standard monobloc stem is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The reverse shoulder prosthesis using the short monobloc stem is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The short monobloc stem is intended for cementless use only.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
• Anatomic Shoulder Prosthesis – monobloc stem
The anatomic shoulder prosthesis using the standard monobloc stem is intended for use as a hemi or total shoulder replacement. It is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.
The anatomic shoulder prosthesis using the short monobloc stem is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The short monobloc stem is intended for cementless use only.
The MSS – Monobloc stem is a Medacta Shoulder System line extension including the following implantable, individually packed, sterile and single-use devices:
- Monobloc stem, 11 sizes available in both standard and short versions. Short version has been designed, as the standard version, made of Ti6Al7Nb with Ti+HA coating, but also made from Ti6Al4V powder through an additive manufacturing process;
- Monobloc stem spacer small and large;
- Monobloc stem double eccenter small and large;
- Monobloc stem spacer/double eccenter screw;
- Distal screws with lengths from 18 to 36 in 2mm steps;
- Humeral reverse liners small and large available both in UHMWPE highcross and UHMWPE + vitamin E;
- Humeral reverse metaphysis small concentric and eccentric.
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(300 days)
The Mpact 3D Metal implants are designed for cementless use in total hip arthroplasty in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Mpact 3D Metal Implants Extension - DMLS Technology are a line extension to the Mpact 3D Metal Acetabular Shells and 3D Metal Augments (K171966, K202568) and to the Mpact Acetabular Systems Shells (K103721, K122641, K132879 and K230011) and are designed to be used with the Medacta Total Hip Prosthesis System. Specifically, the devices subject of this submission are:
- Acetabular shell size Ø44 Two-holes;
- Acetabular shell size Ø44 Multi-holes thin;
- Acetabular shells sizes from Ø42T to Ø58T of both Two-holes and Multi-holes Thin designs, allowing to be coupled with an increase size of liner.
The subject implants are intended to be used during Total Hip Arthroplasty to replace the acetabulum and they are provided individually packed, sterile and single-use. Similarly to the predicate devices, the subject acetabular shells are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder according to ASTM F2924-14.
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(123 days)
NextAR Hip is intended to support the surgeon during Total Hip Arthroplasty (THA) procedures by providing navigational information during bone preparation and positioning of acetabular cup components in skeletally mature individuals during supine or lateral approaches.
NextAR Hip is indicated for use with Medacta hip prosthesis as described in the implants' instruction for use. NextAR Hip provides stereotaxic guidance in reference to a patient's rigid anatomy as registered in CT based or imageless workflows.
As an optional display, the smart glasses can be used auxiliary to the NextAR Hip to view the same information as presented by the NextAR Hip. NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
The NextAR Hip Platform is a computer-assisted surgical navigation platform used to support the surgeon during implantation in hip replacement procedures providing information on bone preparation, instrument guidance, and implant positioning.
The NextAR Hip Platform consists of three components:
- NextAR hardware (composed of NextAR Control Unit, NextAR Tracking System and NextAR Smart Glasses);
- NextAR Hip Software; and
- NextAR Hip stereotaxic instruments.
The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the target. Tracking sensor attached to the pelvis and surgical instruments enable the surgeon to register the position and orientation of the patient's anatomy and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking system is provided sterile.
NextAR Hip Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.
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(446 days)
MyPAO SA patient-specific guides are devices intended to be used as anatomical guides. The guides are specifically designed based on the CT images of the patient (i.e., pelvis, proximal femur, distal femur). The guides are intended to assist the surgeon in the positioning of the acetabular fragment during periacetabular osteotomies to treat patients who require to undergo periacetabular osteotomy. MyPAO SA guides are intended for single use only.
The MyPAO SA guides are a set of patient specific 3D printed guides produced using patients' CT scans, intended to assist the surgeon in reaching the desired level of correction during periacetabular osteotomies.
The MyPAO SA guides represent a range extension as well as a simplified approach with respect to the already existing MyPAO guides cleared within K220706. The MyPAO SA guides, and their related preoperative and postoperative 3D printed bone models, are single-use surgical instruments provided non-sterile to the end-user.
The MyPAO SA Realignment System is composed of:
• One Preop SA guide used to mark the path of the planned line and to drill holes that facilitate placement and fixation of the Realignment SA Guide during the realignment phase.
• One Realignment SA Guide placed on the acetabular and iliac fragments after osteotomy, allowing for intraoperatively assessing the positioning of the acetabular bone fragment.
• 3D printed bone models of the preoperative and postoperative condition of the patient.
The MyPAO SA guides are available in two configurations, allowing to perform both right and left hip surgeries.
Given their design, the MyPao SA guides require a less invasive surgical access with respect to the predicates MyPao guides (K220706). On the other hand, the new MyPao SA guides are not indicated in case of reverse PAO corrections.
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(267 days)
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The MSS - Humeral reverse liners extension is a Medacta Shoulder System line extension aiming to include the following new implants:
- Humeral reverse liners made of Vitamin E Highly Crosslinked polyethylene (E-Cross); and
- Humeral reverse constrained liners available both in Highly Crosslinked Polyethylene (HCPE) and Vitamin E Highly Crosslinked polyethylene (E-Cross).
The MSS - Humeral reverse liners extension implants are intended to be used in the reverse configuration only, in order to replace the humeral side of the gleno-humeral joint. They are available in 4 articular surface diameters and 3 heights. The subject MSS - Humeral reverse liners have been designed to be coupled with Medacta Shoulder System humeral reverse metaphysis and to provide an articular surface for the glenosphere.
The subject liners are implantable devices provided individually packed, sterile and single-use.
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(213 days)
• Versafitcup CC TRIO
The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
• Quadra-P and Quadra-P Collared
The hip prosthesis Quadra-P and Quadra-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The Quadra-P Cemented is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• AMIStem-H, AMIStem-H Collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip Replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• MiniMAX
The MiniMax is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Quadra-H and Quadra-R
The hip prosthesis Quadra -S, Quadra-H and Quadra-R is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The hip prosthesis Quadra-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The Quadra-C size 0 implant should not be implanted in patients with a mass of 65 kg or greater.
• SMS and SMS Collared
The hip prosthesis SMS and SMS Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Mpres
The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.
Total Hip Arthroplasty with the Mpres stem is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head.
- Failure of previous hip surgery:
- Conservative hip surgery,
- Internal fixation,
- Arthrodesis,
- Hip resurfacing replacement.
Partial hip arthroplasty with the Mpres stem is indicated in the following cases:
- Acute traumatic fracture of the femoral head.
- Avascular necrosis of the femoral head.
- Primary pathology involving the femoral head but with a non-deformed acetabulum.
• Mpact Acetabular Shell
The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The aim of this submission is to seek clearance for the addition of a new coating supplier for the following coatings:
- Titanium + Hydroxyapatite coating;
- Hydroxyapatite coating;
- Porous Titanium coating for Mpact devices; and
- Titanium coating for Mpact T sizes devices.
The already FDA cleared devices affected by the change are listed in Table 1 below.
| 510k | Product name | Substrate material | Coating |
|---|---|---|---|
| K103352 K122911 | Versafitcup CC TRIO | Ti-6Al-4V (ASTM F136) | Titanium + Hydroxyapatite |
| K181254 K192827 K202730 | Quadra-P Quadra-P Collared Quadra-P Short Neck | Ti-6Al-7Nb (ISO 5832-11) | Titanium + Hydroxyapatite |
| K161635 K173794 | AMIStem-H Proximal Coating | Ti-6Al-7Nb (ISO 5832-11) | Titanium + Hydroxyapatite |
| K173794 K192126 | AMIStem-P AMIStem-P Collared AMIStem-P Short Neck | Ti-6Al-7Nb (ISO 5832-11) | Titanium + Hydroxyapatite |
| K170845 K192352 | MiniMAX | Ti-6Al-7Nb (ISO 5832-11) | Titanium + Hydroxyapatite |
| K181693 K201673 | SMS | Ti-6Al-7Nb (ISO 5832-11) | Titanium + Hydroxyapatite |
| K203041 | SMS Collared | Ti-6Al-7Nb (ISO 5832-11) | Titanium + Hydroxyapatite |
| K210263 | Mpres | Ti-6Al-7Nb (ISO 5832-11) | Titanium + Hydroxyapatite |
| K093944 K121011 | AMIStem-H AMIStem-H Collared | Ti-6Al-7Nb (ISO 5832-11) | Hydroxyapatite |
| K082792 K093944 K121011 | Quadra-H Quadra-H Short Neck | Ti-6Al-7Nb (ISO 5832-11) | Hydroxyapatite |
| K082792 | Quadra-R | Ti-6Al-7Nb (ISO 5832-11) | Hydroxyapatite |
| K103721 K122641 K132879 K230011 | Mpact Acetabular Shell | Ti-6Al-4V (ASTM F136) | Porous Titanium Porous Titanium / Titanium |
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(58 days)
PowerKnot High Strength Suture is indicated for soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
PowerKnot High Strength Sutures are non-absorbable braided suture constructs made of 100% UHMWPE. They consist of a multifilament core yarn with a braided sheath and they are available in various color options, with or without a stainless steel needle. The PowerKnot High Strength Sutures portfolio also includes a Running Direction Indicator (RDI) surface of the suture, aiding the surgeon when applying the suture.
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(90 days)
The NextAR Shoulder™ Platform supports the surgeon during glenoid implantation in anatomic and reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning.
The NextAR Shoulder™ Platform works in conjunction with NextAR™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System shoulder prosthesis.
As an optional display, the smart glasses can be used auxiliary to the NextAR Shoulder™ Platform to view the same 2D stereotaxic information as presented by the NextAR Shoulder™ Platform.
The NextAR Shoulder™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical procedures by providing information on bone preparation, instrument guidance, and implant positioning. Once registered, the NextAR™ stereotaxic instruments provide reference to a patient’s rigid anatomical structures on the surface of the glenoid that are identified relative to preoperative C.T. based planning.
The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
The NextAR™ Shoulder Platform is a CT based computer-assisted surgical navigation platform used to perform a total shoulder arthroplasty on the glenoid and includes the following components:
- PC based hardware platform; (K210153)
- Optical tracking system; (K210153)
- Augmented Reality glasses; (K210153)
- Platform (K210153)
- navigation software which displays information to the surgeon in real-time;
- Reusable surgical instruments to perform the surgical steps of a shoulder arthroplasty on the glenoid.
The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the markers. Tracking sensors attached to the scapula and surgical instruments enable the surgeon to register the position and orientation of scapula and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking sensors are provided sterile.
NextAR™ Shoulder Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.
The NextAR™ Shoulder system is intended to assist the surgeon in executing a preoperative surgical planning. The navigation platform tracks the surgical instruments in real-time and displays intraoperative and planned surgical parameters on a screen, thus allowing the surgeon to match the intraoperative parameters with the planned ones.
Specifically, the navigation system utilizes established technologies of navigation and via an active infrared camera rigidly coupled with the scapula and an active infrared tracker that can be rigidly coupled to the surgical instruments. The registration of the patient's scapula on the preoperative scapula model is performed through the use of dedicated surgical instruments (pointers) and a dedicated registration algorithm.
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(434 days)
Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells.
Total Hip Arthroplasty is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components.
The Mpact Constrained Liner is an acetabular preassembled liner consisting of an UHMWPE liner incorporating a bipolar head.
The subject device is available in six sizes and two configurations, flat or 10° face-changing.
The Mpact Constrained Liner implants are provided sterile and individually packaged.
The provided document, an FDA 510(k) clearance letter for the "Mpact Constrained Liner," focuses on establishing substantial equivalence for a medical implant. It DOES NOT describe the acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/algorithm-based medical device performance study.
The document details the physical characteristics, intended use, and comparison to predicate devices for a hip joint prosthesis liner. The "Performance Data" section lists various non-clinical tests and validations (e.g., mechanical tests, biocompatibility, shelf-life) which are standard for implantable devices to ensure their physical integrity, safety, and compatibility with the human body. These are not related to "acceptance criteria" and "study proving device meets acceptance criteria" as requested in the prompt, which specifically implies evaluation of an algorithm's performance (e.g., diagnostic accuracy, sensitivity, specificity).
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training, expert and adjudication details, MRMC study, standalone performance, ground truth types, training set details) from this document, as it pertains to a physical medical device and not an AI/algorithm-based device.
To provide the information requested in your prompt, I would need a document describing the regulatory submission and performance evaluation of an AI/algorithm-based medical device.
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