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APTUS Hand Fractures, osteotomies and arthrodesis of the bones of the hand - Hand System - fractures of the distal, middle and proximal phalanges - fractures of the metacarpals - osteotomies of the hand - arthrodeses in the hand - Scaphoid plates - fractures and non-unions of the scaphoid The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.

The subject device includes the APTUS Hand System, which is used for fractures and arthrodesis of the bones of the hand. APTUS Hand plates are offered in two main system sizes, 1.2/1.5 and 2.0/2.3, depending on the screw size. The subject device plates are to be used with Medartis APTUS TriLock locking screws and SpeedTip screws. - Non-locking plates 1.2/1.5 use cortical screw sizes of either 1.2 or 1.5 mm, and SpeedTip screw size of 1.5mm - TriLock locking plates 1.2/1.5 use locking screws sizes of either 1.2 or 1.5 mm, but also accepts cortical screw sizes of 1.2 or 1.5mm as well as SpeedTip screw size of 1.5mm - TriLock locking plates 2.0/2.3 use locking screws size of 2.0 mm, but also accepts cortical screw sizes of 2.0 or 2.3 mm The APTUS Hand plates are anatomically pre-contoured with respect to the anatomy of the specific bone they are designed for. Most plates may be additionally cut and bent intraoperatively for a wide range of applications. The subject device screws consist of non-sterile TriLock Screws (locking)and SpeedTip Screws ( non-locking). TriLock Screw heads have spherical three point wedge locking design to create a friction-lock connection through radial bracing of the screw head in the plate, thereby creating uniform distribution of stresses over the screw head and plate. The SpeedTip Screws feature a self-cutting screw tip for insertion without prior drilling. The subject device plates are compatible with washers, screws and k-wires previously cleared K102537 (for washers and screws) and K092038 (for k-wires). Plate designs are available either non-sterile. Plates provided non-sterile are intended to be sterilized by the end user before use. The 510(k) of the subject devices K051567 and K102537 APTUS Hand Group and K234062 APTUS Hand Scaphoid will be grouped in the APTUS Hand System. As a result, the indication will be updated for better clarity. This change does not affect the design, materials, or functionality of the devices. APTUS Elbow Dorsal Olecranon Plates The purpose of this 510(k) submission is to obtain marketing clearance for the APTUS Elbow Dorsal Olecranon Plates to expand the range of Medartis APTUS fixation devices provided to the end user in a sterile condition. The non-sterile devices were previously cleared under K240613. The sterilization process proposed for the APTUS System has also already been cleared under K232144, Sterile Products of the APTUS System, the reference device for this submission. The Indication for Use, the Design and the Material are the same as in the previously cleared predicate device K240613 APTUS Elbow Dorsal Olecranon Plates. Sterile Products of the APTUS Elbow Dorsal Olecranon screws are made of titanium alloy conforming to ASTM F136 Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Sterile products of the APTUS Elbow Dorsal Olecranon K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18 Chromium -14 Nickel-2.5 Molybdenum Stainless Steel Wire for Surgical Implants (UNS S31673), Sterile products of the APTUS Elbow Dorsal Olecranon washers are made of unalloyed titanium, Grade 4, conforming to ASTM F67.

The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.

The subject device APTUS Elbow Dorsal Olecranon Plates are available in three (3) designs: Standard, Medium and Extended. The designs differ in the shape of the proximal ends of the Standard Plates are available in 6 lengths; The Medium Plates are available in 2 lenghts and the Extended Plates are available in 3 lenghts, each for left and right. All plates have appropriate for the olecranon. The subject device plates are compatible with screws and k-wires previously cleared in K051567, K09332, K112560, K232144 (for screws) and K092038 (for k-wires). The subject device plates are manufactured from titanium alloy, conforming to ASTM F136. All plates are provided sterile and selected plates are provided non-sterile aswell.

The APTUS Foot System 2.8-3.5 is indicated for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking). The APTUS TriLock Screws, Cortical Screws and Cancellous Screws that are compatible with the subject device plate are manufactured from titanium alloy conforming to ASTM F136. The APTUS K-Wires that are compatible with the subject device plates are manufactured from stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). The device-specific instruments (templates) are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700). The subject device Medartis APTUS Foot System 2.8-3.5 consisting of following plates and systems: 2.8 TriLock Plate Straight, 2.8 TriLock Plate Hole T Extended and 2.8 TriLock TMT-1 Medial Fusion Plates Large, APTUS Mid- and Hindfoot System 2.8/3.5 and Fusion System 3.5. The APTUS Mid- and Hindfoot System 2.8/3.5 includes TriLock 2.8 C Plates, 2.8 TriLock Calcaneus LCL Plates, 3.5 TriLock Calcaneus LCL Plates and 3.5 TriLock Calcaneus Step Plates. The subject device also includes sterile wedges that are used to support fixation of an opening wedge osteotomy. The wedges are stabilized by corresponding wedge screws that are placed through a plate. The subject device wedges are provided in two size series. The APTUS Fusion System 3.5 includes 3.5 TriLock Wing Plates, 3.5 TriLock Butterfly Plates, 3.5 TriLock TNC Fusion Plates, 3.5 TriLock NCM Fusion Plates, 3.5 TriLock TNCM Fusion Plates, 3.5 TriLock Talonavicular Fusion Plates. Furthermore, 3.5 TriLock Medial Column Fusion Plates, 3.5 TriLock Distal Medial Column Fusion Plates, 3.5 TriLock Proximal Column Fusion Plates. The APTUS Fusion System 3.5 plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The 2.8 TriLock Straight Plates are generic straight plates and used with 2.8 mm screws. The 2.8 TriLock Plate Hole T Extended are generic T plates and used with 2.8 mm screws. The 2.8 TriLock TMT-1 Medial Fusion Plates Large plates have anatomical designs that are appropriate for either the left or the right foot. The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700). The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking).

APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.

The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Hand Plates, previously cleared under K102537. The subject device APTUS Hand Scaphoid Plates is available in three designs - small, standard, large - all with 6 screw holes. All plates have anatomical designs that are appropriate for the scaphoid. The subject device plates are compatible with screws and k-wires previously cleared in K102537, K051567, K232144 (for srews), K092038, K202589 and K232144 (for k-wires). The subject device plates are manufactured from unalloyed titanium conforming to ASTM F67, and are provided non-sterile and sterile.

APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size in the shoulder, elbow, wrist, hand, knee, and the foot and ankle. APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as guide pins for insertion of other implants.

The purpose of this submission is to obtain marketing clearance for APTUS® Cannulated Compression Screw, and APTUS® K-Wire System designs to expand the range of Medartis APTUS fixation devices previously cleared in K133460. K110658. K092038 and K202589. This submission includes for APTUS® Cannulated Compression Screws (non-sterile): - additional thread lengths for previously cleared thread diameters (2.2 mm, 3.0 mm, and 4.0 mm) - fully threaded screws for two previously cleared thread diameters (2.2 mm and 3.0 mm) Additionally, the purpose of this submission is to obtain marketing clearance for various APTUS® Kwire designs (non-sterile and sterile) to expand the range of the Medartis APTUS® K-Wire System, previously cleared in K092038, K133460 and K202589, to include longer versions in two (2) diameters (0.8, 1.1 mm). The K-wires are compatible with the subject device cannulated compression screws and APTUS® Cannulated Compression Screws previously cleared in K110658, K133460 and K202589. All subject device cannulated compression screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum- 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same material for screws previously cleared in K110658, K133460 and K202589. The subject device K-wires are manufactured from stainless steel conforming to ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673), the same material for K-wires previously cleared in K092038, K133460 and K202589.

The APTUS® Titanium Fixation System is indicated for use in hand and forearm fractures and arthrodeses. APTUS® Hand group: - · Management of the fractures of the distal, middle and proximal phalanges and metacarpals - · Management of all types of transversal fractures, spiral fractures near joints with or without joint - involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures - · DIP and PIP arthrodeses - APTUS® Radius 2.5 group: - · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures - Management via dorsal approach of ractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions. APTUS® 2.0/2.3 Four Corner Fusion Plate The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand. APTUS® K-Wire System The APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as guide pins for insertion of other implants. APTUS® 1.5 TriLock The APTUS® 1.5 TriLock is indicated for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Hand group: - · Management of the fractures of the distal, middle and proximal phalanges and metacarpals - · Management of all types of transversal fractures, fractures near joints with or without joint - involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures - DIP and PIP arthrodeses - APTUS® Radius 2.5 group: - · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures - Management via dorsal approach of ractures that cannot be adequately reduced via volar approach. procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions. APTUS® Ulna Plates APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna. APTUS® Wrist 2.5 System APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures and arthrodeses. APTUS® Wrist Arthrodesis Plates APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis. APTUS® Forearm Shaft Plates APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.

The Sterile Products of the APTUS System is a plating, screw, and K-wire system for internal fixation of the hand, wrist, and/ or forearm. All plates have anatomical designs that are appropriate to their intended use. The subject device plates includes crew holes designed to accommodate appropriately sized bone screws. Sterile Products of the APTUS System plate, screw, and K-wire system are the previously cleared predicate and additional predicate devices. The overal dimens of the subject device plates have the same lengths, widths, and thicknesses as the previously cleared predicate and additional predicate device screws have the same design as the previously cleared Medartis APTUS Screws under K051567, K103332, and K142906. These include both locking (cortical) screws. The subject device K-wires have design as the previously cleared APTUS K-Wires System under K092038. The K-wires are provided with a diameter of 1.2, 1.6, or 1.8 mm. All have a length of 150 mm. Single-ended trocar points are provided in 1.2 mm and 1.6 mm diameters, and single-ended bayonet (lancet) points are provided at all 3 diameters. This submission includes all plates screws, and K-wires that have been previously cleared under the predicate devices by Medartis AG, however, they will be provided in a sterile condition. All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67. All subject device screws are manufactured from titanium alloy conforming to ASTM F136. All subject device K-wires are manufactured from stainless steel conforming to ASTM F138. All subject devices are associated with the predicate device and/or an additional predicate device mentioned in the predicates and product list sections.

The APTUS 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of the scapula, olecranon, radius, ulna, foot, distal tibia and fibula.

The subject device APTUS 3.5 TriLock Straight Plates are available in eleven (11) designs with 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, or 16 screw holes. The plates have an overall length ranging from 32 mm to 200 mm. The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The subject device plates are compatible with screws and K-wires previously cleared in K193633, K110908, and K092038. The subject device plates are manufactured from titanium alloy conforming to ASTM F136, and are provided non-sterile or sterile to the end user.

APTUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Ulna Plates, previously cleared under K 103332. The subject device APTUS Distal Ulna Plates is available in four (4) designs with 10 or 12 screw holes. All plates have anatomical designs that are appropriate for either the right ulna. The 10 and 12 hole plates have a length of 53 mm and 66 mm, respectively. The maximum thickness of the plates is 1.6 mm and the maximum width is 15 mm. The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The subject device plates are compatible with screws and K-wires previously cleared in K051567 (TriLock), K103332 (cortical), and K092038 (K-wires). The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67, and are provided non-sterile and sterile.

APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are intended for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size. APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

The subject device includes APTUS Cannulated Compression Screws in thread diameters 1.7 mm, 2.2 mm, 3.0 mm, 5.0 mm, and APTUS headed Cannulated Compression Screws in diameters 2.2 mm, 3.0 mm, 5.0 mm, and 7.0 mm. APTUS Cannulated Compression Screws are headless screws that incorporate threads with different pitch on the head and tip of the screws; this difference in pitch provides compression as the screw is inserted. APTUS headed Cannulated Compression Screws have conventional bone screw heads that apply compression between the threads and the head. Both types of screws provide compression of the bone segments upon insertion of the screw. Additionally, all subject device screws have a triangular SpeedTip® shape designed to improve cutting and insertion torque and an internal hexalobular instrument face. The APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression Screws come in partially threaded and fully threaded designs. The 1.7 mm diameter screws are provided in overall lengths ranging from 8 mm to 20 mm. The 2.2 mm diameter screw are provided in overall lengths ranging from 10 mm to 40 mm. The 3.0 mm diameter screws are provided in overall lengths ranging from 10 mm to 40 mm. The 4.0 mm diameter screws are provided in overall lengths ranging from 16 mm to 60 mm. The 5.0 mm diameter screws are provided in overall lengths ranging from 24 mm to 70 mm. The 7.0 mm diameter screws are provided in overall lengths ranging from 30 mm to 140 mm. The subject device 1.7 mm, 2.2 mm, 4.0 mm, 5.0 mm, and 7.0 mm thread diameter APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression screws are used with the corresponding subject device K-wires (0.6, 0.8, 1.1, 1.25, 1.6, and 2.2 mm, respectively). The subject device screws also are compatible with the Medartis K-wires cleared under K092038. Similarly, the subject device K-wires are compatible with the APTUS Cannulated Compression Screws cleared under K133460 and K110658. This submission also includes the corresponding washers for APTUS headed Cannulated Compression Screws. The subject device cannulated compression screws and washers are manufactured from titanium allov conforming to ASTM F136 Standard Specification for Wrought Titanium-61 anadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject device K-wires are manufactured from stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). All subject devices are provided non-sterile to the end user. The subject devices are single-use only.

APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.

The subject device includes various designs for internal fixation of the distal tibia and distal fibula; additional lengths of 3.5 TriLock Screws (locking screws, other lengths cleared in K110908); a new design of 3.5 Cortical Screws (non-locking) in various lengths; and a new design of concave washer for use with Medartis 3.5 Cortical Screws. The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The plat designs include: 3.5 TriLock Distal Tibia L Plates and T Plates; 2.8/3.5 TriLock Distal Tibia Plates Medial; 2.8/3.5 TriLock Distal Tibia Plates Anterolateral; 2.8/3.5 TriLock Distal Fibula Plates Lateral, with and without Flap; 2.8 TriLock Distal Fibula Plates Crossed; and 2.8 TriLock Distal Fibula Plates Straight. The subject device plates are used with TriLock locking screws and non-locking screws (cortical and cancellous), including subject device screws and previously cleared Medartis screws. Compatible TriLock locking screws and non-locking cortical screws have a diameter of 2.8 mm and 3.5 mm, and overall lengths ranging from 8 mm to 60 mm. The 2.8 Cortical Screws (non-locking) and 3.5 Cortical Screws (non-locking) have a double-lead thread design. All TriLock Screws (locking) have a double-lead thread design. The subject device plates also are compatible with Medartis K-Wires cleared in K092038. The subject device screws include screws with the same design as 3.5 TriLock Screws cleared in K110908, with a diameter of 3.5 mm and provided in additional lengths of 10 mm, 12 mm, and 14 mm. The subject device screws also include a new design of 3.5 Cortical Screws provided with a diameter of 3.5 mm and lengths of 10 mm to 60 mm. The subject device plates, washer, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. The subject device components are provided non-sterile to the end user.