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The DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DePuy Synthes Dynamic Hip Screw (DHS) plating system.
The DePuy Synthes Trochanter Stabilization Plate (TSP) for the Dynamic Hip Screw System (DHS®) is intended to to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DHS® System.
The DePuy Synthes Proximal Humeral Nail is intended for use in fractures of the proximal humerus.
The DePuy Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
The DePuy Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including: supracondylar fractures, including those with intra-articular extension; ipsilateral hip/shaft fractures; ipsilateral femur/tibia fractures; femoral fractures in multiple trauma patients; fractures proximal to total knee arthroplasty; fractures distal to a hip implant; fractures in the morbidly obese; fractures in osteoporotic bone, impending pathologic fractures; malunions and nonunions
The DePuy Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatic applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes LCP Dynamic Helical Hip System, Additional Helix Blades is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
The DePuy Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after turnor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
The DePuy Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) for DHS or LCP DHHS is intented to treat stable and unstable intertrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS) or the LCP Dynamic Helical Hip System (DHHS) side plates with four or more holes.
The DePuy Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, and revisions.
The DePuy Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions in adolescent and small stature adult patients.
The DePuy Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranion osteotomies as well as simple fractures of the olecranon.
As part of the DePuy Synthes Trochanteric Fixation Nail (TFN) System, the DePuy Synthes Trochanteric Fixation Nail (TFN) Screw is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
The DePuy Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to treat stable unstable fractures of the proximal femur including pertrochanteric fractures, and intertrochanteric fractures, basal neck fractures and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
The DePuy Synthes Trochanteric Fixation Nail - Advanced (TFNA) System is intended for treatment offractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for: Stable and unstable pertrochanteric fractures, Intertrochanteric fractures, Basal neck fractures, Combinations of pertrochanteric, intertrochanteric and basal neck fractures. The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused for the following indications: Subtrochanteric fractures, Pertrochanteric fractures associated with shaft fractures, Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, Long Subtrochanteric fractures, Proximal or distal non-unions, malunions and revisions.
The DePuy Synthes Universal Femoral Nail is intended for use in stabilizing fractures of the femur. More specifically, the primary intended use is stable midshaft (diaphyseal) femoral fracture and hypertrophic pseudarthrosis (non-union) or unstable femoral fracture stabilization.
The DePuy Synthes Universal Tibial Nail and the DePuy Synthes Unreamed Tibial Nail are intended for use in stabilizing fractures of the tibia. More specifically, the primary intended use of the Universal Tibial Nail is stable diaphyseal fractures or long or rotationally-unstable diaphyseal fractures, including rotationally unstable proximal and distal diaphyseal fractures. For the Unreamed Tibial Nail, the specific intended uses are Grade I and II open tibial diaphyseal fractures; high energy, unstable, closed fracture patterns; comminuted fractures of tibias with small medullary canals; and certain pre- and postisthmic fractures.
The DePuy Synthes TI-6AI-7NB Unreamed Femoral Nail is intended for use in stabilizing fractures of the femur. Specific Indications: Acute femoral diaphyseal fractures; post-isthmic femoral fractures; subtrochanteric femoral fractures.
The DePuy Synthes TI-6AL-7NB Unreamed Tibial Nail (URTN) is intended to stabilize fractures of the tibia. Specifically, it is intended for grade I and II open tibial diaphyseal fractures; high energy, unstable, closed fracture patterns; comminuted fractures of tibiae with small medullary canals; and certain pre- and post-isthmic fractures.
The accessories are intended for use with the DePuy Synthes Titanium Alloy Unreamed Femoral Nail (URFN), which is intended for use in stabilizing fractures of the femur. The Synthes Twisted Blade and 5.0 mm Shaft Screw, used with the Locking Sleeve and End Cap, are intended to transmit load between the bone and the URFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures (short, long, reverse oblique and comminuted).
The DePuy Synthes Unreamed Humeral Nail (URHN) is intended to stabilize fractures of the humerus. It is specifically indicated for acute humeral shaft fractures, pathologic or impending pathologic fractures of the humeral shaft, and non- and mal unions of the humeral shaft.
The DePuy Synthes Cannulated Femoral Nail (CFN) is intended to stabilize fractures of the femur. Specifically, the primary intended use is acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions and impending pathological fractures.
The DePuy Synthes Titanium Cannulated Tibial Nail (TI CTN) is intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions.
The DePuy Synthes Proximal Femoral Nail (PFN) System is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures.
The DePuy Synthes Titanium Distal Femoral Nail (TI DFN) System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intra-articular and/or extra-articular involvement), pathologic fractures, mal-unions, non-unions, ipsilateral hip/shaft fractures, ipsilateral femur/ tibia fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient. fractures in the morbidly obese patient, and fractures in osteoporotic bane. The Ti DFN can be used in either reamed or non-reamed applications.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes Spiral Blade for Humeral Nail (SBHN) is intended to stabilize fractures of the humerus.

The DePuy Synthes Trochanter Stabilization Plate for DHS is a component of the DePuy Synthes DHS System, which fits over the sideplate of the DHS. The spoon-shaped area of the TSP, which is proximal to the shaft, resides along the greater trochanter. Screw holes of the TSP shaft line up with the screw holes of the DHS plate to accept the 4.5 mm cortex screws used for fixation to the femoral shaft. Two screw slots accommodate the DHS lag screw and the anti-rotational screw located proximal to it. The DePuy Synthes Trochanter Stabilization Plates are provided both pre-sterilized by gamma radiation and nonsterile.
The DePuy Synthes TSP line extension is a shorter length version of the currently marketed TSP Plating System. It is a component of the DePuy Synthes DHS System, which fits over the sideplate of the DHS. The spoon-shaped area of the TSP, which is proximal to the shaft, resides along the greater trochanter. Four (4) screw holes in the TSP shaft line up with the screw holes of the DHS plate to accept the 4.5 mm cortex screws used for fixation to the femoral shaft. Two screw slots accommodate the DHS lag screw and the anti-rotational screw located proximal to it. DePuy Synthes Trochanter Stabilization Plate is provided both pre-sterilized by gamma radiation and nonsterile.
The DePuy Synthes Proximal Humeral Nail is an intramedullary rod that features a distal taper design. It is 150 mm in length and has holes in both the proximal and distal sections that accept locking screws.
The DePuy Synthes Trochanteric Fixation Nail (TFN) System consists of a cannulated intermedullary nail, a cannulated helical blade and cannulated nail end cap. The TFN Nail is anatomically contoured with a proximal diameter of 17 mm, tapering to a nominal diameter of 10, 11 or 12 mm. The proximal locking hole accommodates angles ranging from 125 - 135°. TFN nails are to be available in short lengths (170 - 235 mm) and long lengths (300 - 460 mm), with the long length nails available in right or left versions. The Trochanteric Fixation Nail accepts commercially available Synthes 4.9 mm Locking Bolts and/or 5.0 mm Locking Screws.
The DePuy Synthes Retrograde Femoral Nail System is composed of femoral nails, spiral blades and end caps. Depending on the length of the nail may be inserted from a retrograde approach or from either a retrograde approach. Spiral blades, end caps and Synthes commercially available locking bolts and screws are used to secure the nail in the bone, preventing rotation and axial compression
The DePuy Synthes Lateral Entry Femoral Nail System is composed of cannulated femoral nails, solid 6.5 mm recon locking screws and cannulated end caps. Recon locking screws, as well as Synthes commercially available 5.0 mm and 6.0 mm locking screws, are used to secure the nail in the bone.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) consists of flexible intramedullary fixation devices that vary in diameters and lengths, which can be cut to size intraoperatively. The EIN has a curved tapered tip to facilitate insertion and manipulation. The EIN is manufactured from Titanium Alloy.
The DePuy Synthes LCP Dynamic Helical Hip System, Additional Helix Blades is a plate and screw system that consists of a straight plate with an angled barrel that accepts a helical blade. Synthes Helical blades, ranging in lengths from 135 mm are to be added to this system.
The DePuy Synthes Hindfoot Arthrodesis Nail System is composed of titanium cannulated arthrodesis nails, 6.0 mm Locking Screws, and end caps. DePuy Synthes commercially available spiral blades, locking screws, and locking bolts are used to secure the nail in the bone, preventing rotation and axial compression.
The DePuy Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) for DHS® and LCP DHHS fits over the sideplate of the DePuy Synthes DHS and LCP®DHHS. The ULTSP screw holes line up with the most proximal screw holes of the DHS and LCP DHHS sideplate and accept 4.5 mm cortex screws used for femoral shaft fixation. Slots accommodate both the DHS lag screw or the LCP DHHS Helix Blade and a parallel anti-rotational screw. The screw slot for the antirotational screw accepts a 6.5 mm cancellous bone screw or 6.5 mm, 7.0 mm or 7.3 mm cannulated screw. The proximal extension of the plate resides along the lateral side of the greater trochanter. The proximal locking holes of the ULTSP accept 3.5 mm locking screws and/or k-wires, cables, or sutures up to 2.0 mm in diameter.
The DePuy Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades consists of a cannulated femoral nail, a cannulated helical blade and a cannulated nail end cap. DePuy Synthes Helical Blades will be available in three additional lengths, 75 mm, 125 mm, and 130 mm.
The DePuy Synthes Adolescent Lateral Entry Femoral Nail System is composed of cannulated femoral nails, solid 5.0 mm recon locking screws and cannulated end caps. Recon locking screws, as well as Synthes commercially available 4.0 mm locking screws, are used to secure the nail in the bone.
The DePuy Synthes Olecranon Osteotomy Nailing System consists of machined metallic olecranon nails, end caps and screws which are designed for use in fixation of fractures and osteotomies of the olecranon process of the ulna. The DePuy Synthes Olecranon Osteotomy Nailing System offers a unique alternative to current techniques for olecranon fracture and Olecranon osteotomy fixation. The system allows for quick realignment of the olecranon fragment following procedures which are primary to the repair of the olecranon osteotomy.
The DePuy Synthes Trochanteric Fixation Nail (TFN) Screw is a threaded component composed of titanium alloy which is intended for use with DePuy Synthes Trochanteric Fixation Nails to provide stabilization of fractures of the proximal femur.
The DePuy Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN) is an additional offering for use with the existing TEN System. The Set Screw prevents sliding and rotation of the head element (TFN Screw or helical blade) within the nail for fixation of proximal femur fractures.
The DePuy Synthes Trochanteric Fixation Nail - Advanced (TFNA) System consists of cephalomedullary nails, screw and blade head elements, end caps, distal locking options, and device specific insertion/removal instruments.
The DePuy Synthes Universal Femoral Nail, regardless of whether Synthes provides sterile or non-sterile for subsequent sterilization by the user institution, is manufactured from 316L stainless steel seamless tubing with a nominal thickness of 1.25 mm. It is available in sizes ranging from 10 mm to 19 mm in diameter and 300 mm in length. The nail has a gradual bow with a radius of curvature of 1.5 m which closely resembles the average femur. The nail is slotted along its anterior length to facilitate implantation. The nail has two proximal and two distal 5.0 mm diameter transverse locking holes which accept locking screws.
The DePuy Synthes Universal Tibial Nail is made from stainless steel tubing with a nominal wall thickness of 1.25 mm. It is available as 10 mm, 11 mm, 13 mm, and 14 mm in diameter and lengths ranging from 240 mm to 360 mm in length (in 15 mm increments), and 360 mm to 420 mm in length (in 20 mm increments). The nail has a bend with an angulation of 11°, which facilitates insertion in the average tibia. The nail is slotted along its posterior length for flexibility during implantation and explantation. The nail has two 5.0 mm diameter locking holes and a slot proximally, and three 5.0 mm diameter locking holes distally which accept locking screws. The DePuy Synthes Unreamed Tibial Nail is available in sizes ranging from 8 mm to 9 mm in diameter and in 15 mm increments from 255 mm to 360 mm in length, and 20 mm increments from 360 mm to 420 mm in length. The nail has a bend with an angulation of 9° which facilitates insertion in the average tibia. The nail has two 4.0 mm diameter locking holes proximally and two locking holes distally which accept locking screws.
The DePuy Synthes TI-6AI-7NB Unreamed Femoral Nail is intended to stabilize fractures of the Specifically, the primary intended use is acute femoral diaphyseal fractures, postfemur. isthmic femoral fractures and subtrochanteric femoral fractures.
The DePuy Synthes TI-6AL-7NB Unreamed Tibial Nail (URTN) is intended for use in stabilizing fractures of the tibia. It is available in diameters of 8 mm - 9 mm, and lengths from 255 mm to 420 mm. The nail has a proximal angulation of 9° in the sagittal plane; it allows for interlocking with locking bolts.
The Accessories to DePuy Synthes Titanium Alloy Unreamed Femoral Nail (URFN) are compared to Synthes 4.9 mm Locking Bolt. The accessories include: DePuy Synthes twisted blade, 5.0 mm shaft screw, locking sleeve, and end cap. They are available in a variety of lengths.
The DePuy Synthes Unreamed Humeral Nail (URHN) has a 5° bend positioned 55 mm from the proximal end, and is available in lengths ranging from 180 mm to 360 mm in 20 mm increments. The nail is available in three diameters: 7.5 mm, and 9.5 mm. The nail has three proximal locking holes, and two distal locking holes oriented 90° to each other. All of the locking holes accept 4.0 mm self-tapping cancellous screws or 3.9 mm locking bolts. A cap screw threads into the proximal end of the nail.
The DePuy Synthes Cannulated Femoral Nail (CFN) is a cannulated, locking intramedullary fixation device. The nail is available in diameters ranging from 10 to 15 mm, and lengths ranging from 300 mm to 480 mm. Each nail has the same proximal design, and then tapers (10 - 12 mm) or expands (13 - 15 mm) to the nominal diameter. The nail has a radius of curvature of 1.5 meters. The CFN has four 5 mm holes (two proximal and two distal) to allow interlocking with 4.9 mm Locking Bolts. The most proximal locking hole is elongated to allow for dynamization (compression of bone fragments) of the fracture, if desired.
The DePuy Synthes Titanium Cannulated Tibial Nail (TI CTN) is available in sizes ranging from 11 mm to 14 mm in diameter and from 255 mm to 420 mm in length. The nail is a cannulated tube with a 9° bend in the sagittal plane which facilitates insertion into the tibia. There are four locking holes proximally and there are three locking holes distally. All of the locking holes accept 4.9 mm Titanium Locking Bolts.
The DePuy Synthes Proximal Femoral Nail (PFN) System is an intramedullary nail which utilizes a weight bearing dynamic femoral neck screw and an anti-rotational parallel hip pin. Distal interlocking is performed with an aiming arm and can be either static or dynamic. The following components make up the PFN system: proximal femoral nails, hip pins, femoral neck screws, 4.9 mm locking bolts, and 17 mm end caps.
The DePuy Synthes Titanium Distal Femoral Nail (TI DFN) System is a cannulated and solid locking intramedullary fixation device. The following components make up the DFN system: Transverse Locking Nails, 6.0 mm Ti Locking Screws, 4.9 mrn Ti Locking Bolts, and End Caps.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes Spiral Blade for Humeral Nail (SBHN) is a component of DePuy Synthes Unreamed Humeral Nail System. The DePuy Synthes Spiral Blade is used in conjunction with the DePuy Synthes Unreamed Humeral Nail to stabilize fractures of the humerus. The SBHN has a 3.9 mm core diameter, a 10.5 mm blade width with nail slots that are 12 mm wide, has suture holes located around periphery of blade head, and is available in lengths ranging from 34 mm to 54 mm. A Locking End Cap is used to lock the Spiral Blade in place. The Locking End Cap has a 5 mm extension and a 3.5 mm hex drive.

It seems there is a misunderstanding. The FDA document provided is a 510(k) premarket notification for a list of orthopedic fixation devices. This document does not describe acceptance criteria for an AI/ML powered device, nor does it present a study proving a device meets such criteria.

Instead, the document details a series of traditional medical devices (bone fixation appliances) and outlines that their manufacturer, DePuy Synthes, is seeking to update the labeling to include "MR Conditional" information. This means the manufacturer has performed non-clinical testing to demonstrate the conditional safety of these physical implants in an MRI environment.

The core of each "Substantial Equivalence" section (e.g., [32], [34], [36], etc.) explicitly states:

"The purpose of this submission is to add MR Conditional information to the device labeling... The intended use and technological characteristics of the devices remains unchanged."

And for the non-clinical testing:

"Non-clinical testing is provided to support the conditional safety... in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy."

Therefore, I cannot provide the information requested for an "AI/ML powered device" as it is not present in the provided text. The document is about physical implants (nails, plates, screws) and their compatibility with MRI machines.

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