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The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation. K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management. The K-Wires are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The subject device Cannulated Headless Bone Screws are cannulated at both the leading end (tip) and at the trailing end. The leading/trailing diameters are: 2.5/3.4 mm. 3.5/4.5 mm. 4.0/4.8 mm. 4.5/5.3 mm, 5.5/6.2 mm, 6.5/7.2 mm, and 7.5/7.9 mm., The leading thread have different pitches which facilitates closure of any fracture gap and generates compression across the bone fragments. The subject screws are provided in overall lengths ranging from 12 mm, and with threaded lengths (at the leading end or tip) ranging from 4 mm to 40 mm. The subject screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3. The subject K-Wire is provided in one size with a diameter of 2.4 mm and a length of 250 mm. The subject K-Wire has a trocar point, is threaded, and is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1.

The LOQTEQ® VA Elbow Plates 2.7/3.5 includes the LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 and LOQTEO® VA Olecranon Plate 2.7/3.5. LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 are indicated for: - Intra-articular fractures of the distal humerus · Supracondylar fractures of the distal humerus · Osteotomies, and non-unions of the distal humerus LOQTEQ® VA Olecranon Plate 2.7/3.5 is indicated for: · Fixation of fractures, osteotomies and non-unions of the olecranon, particularly in osteopenic bone

The components of the LOOTEO VA Elbow Plates 2.7/3.5 are trauma implants, bone plates and screws, which are implanted into the human body to achieve an internal fixation of bone fragments, typically after fractures or other bone injuries (e.g., joint reconstruction). LOQTEQ plates function according to the fixateur interne principle, i.e., they incorporate an angular stable plate-screw connection as a result of screwing threaded screw heads into threaded plate holes. Conventional bone screws can be used in all plate holes and allow for off-axis angulation up to 15° inside threaded plate holes. After fracture healing, the implants (plates and screws) are to be removed. The shape of the bone plates is adapted to the anatomy of and the biomechanical stress on the distal humerus and the olecranon (ulna), respectively. The LOQTEQ VA Elbow Plates 2.7/3.5 consists of the LOQTEQ VA Distal Dorsolateral Humerus Plate, LOQTEQ VA Distal Lateral Humerus Plate, LOQTEQ VA Distal Medial Humerus Plate and the LOQTEQ VA Olecranon Plate 2.7/3.5.

The LOQTEQ® Proximal Humerus Plate 3.5 System is intended for fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

The subject device includes a total of nine (9) bones plates for internal fixation of bone fragments. i.e., for treatment of bone fracture and other bone injuries. All LOOTEO® Proximal Humerus Plate 3.5 are available non-sterile. The subject device is provided in anatomic designs in overall lengths of 85 mm, 92 mm, 105 mm, 118 mm. 143 mm. 169 mm. 195 mm. 221 mm. and 247 mm. The plates are provided with 3, 4, 5, 6. 8, 10, 12, 14, and 16 holes, respectively, in plate. The lengths of 92 mm, 118 mm, 143 mm, 169 mm, and 195 mm are identical to the plates previously cleared in K121495. Subject device lengths of 85 mm, 221 mm, and 247 mm are identical to the plates previously cleared in K121495 except for the length and number of holes. The subject device plates include screw holes designed to accommodate appropriately sized locking and non-locking cortical and periprosthetic bone screws, previously cleared in K121495, and K-wires cleared in K131459, presented marked as part of the LOQTEQ® Proximal Humerus Plate 3.5 System. The compatible screws are 3.5 mm in diameter. The subject device plates are also compatible with the 1.6 mm diameter app K-Wires.

Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions; and osteotomies of the femur

The subject device includes a total of 14 bones plates for internal fixation of the distal lateral femur. All LOQTEQ Distal Lateral Femur Plates 4.5 are available non-sterile. The subject device is provided in anatomic designs in overall lengths of 153 mm, 207 mm, 243 mm, 279 mm, 314 mm, 350 mm, and 386 mm, for the left and right distal femur. The plates are provided with 4, 7, 9, 11, 13, 15, and 17 screw holes, respectively, in the shaft of the plate. Lengths of 153 mm, 207 mm, 279 mm, 279 mm, and 314 mm are identical to the plates previously cleared in K121494. Subject device plates in lengths of 350 mm and 386 mm are identical to the plates previously cleared in K121494, except for the length. The subject device plates include screw holes designed to accommodate appropriately sized locking and non-locking cortical and periprosthetic bone screws, previously cleared in K121494 and K072411 and K-wires, previously cleared in K131459, presently marketed as part of the LOQTEQ Distal Lateral Femur Plate 4.5 System. The compatible screws are 4.5 mm in diameter. The subject device plates also are compatible with 2.0 mm diameter aap K-Wires.

For fractures and osteotomies of the calcaneus, including, but not limited to -extra-articular, intra-articular -joint depression -tongue type -severely comminuted fractures

The LOQTEQ® VA Calcaneus Plate 3.5 is an anatomical, polyaxial angular stable, asymmetrical titanium plate (L/R version) for the treatment of calcaneus fractures. The shape of the plate is adapted to the lateral, anatomical shape of the calcaneus. The polyaxial, angle-stable plate-screw-connection (VA technology) allows up to 15° angulating of the screws. Thus, the screws can be placed under the posterior articular facet into the sustentaculum tali, ensuring a stable supply of the fracture.

The system LOQTEQ® VA Foot Plates 2.5 is intended for use in stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of bones of the feet. Implants are intended for single use on adult human bone. LOQTEQ® VA Plantar Fusion Plate 2.5, TMT 1: - plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure) LOQTEQ® VA L-Fusion Plate 2.5: - LisFranc Arthrodesis and/or Stabilization - 2nd Tarsometatarsal (TMT) Fusions LOQTEQ® VA Straight Fusion Plate 2.5: - LisFranc Arthrodesis and/or Stabilization - 3rd Tarsometatarsal (TMT) Fusions LOQTEQ® VA Osteotomy Plate 2.5: First metatarsal osteotomies for hallux valgus correction including: - Opening base wedge osteotomy - Closing base wedge osteotomy - Proximal Chevron osteotomy LOQTEQ® VA MTP Fusion Plate 2.5: Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Primary MTP Fusion due to hallux rigidus and/or hallux valgus LOQTEQ® VA MTP Revision Plate 2.5: Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Revision MTP Fusion - Revision of failed first MTP Arthroplasty implant LOQTEQ® VA Metatarsal Straight Plate 2.5/LOQTEQ® VA Metatarsal L-Plate 2.5/LOQTEQ® VA Metatarsal T-Plate 2.5 - Metatarsal or metacarpal fractures and osteotomies - Phalanges fractures and osteotomies LOQTEQ® VA X-Plate 2.5: - fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including the foot LOQTEQ® VA Hook Plate 2.5: - internal bone fixation for bone fractures of the 5th metatarsal of the foot LOQTEQ® VA Plantar Fusion Plate 3.5, TMT 1: - plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure)

The LOQTEQ® VA Foot Plates 2.5 includes invasive products for the implantation on bones of the foot. The implants consist of a titanium-aluminum-vanadium alloy (TiAl6V4) and have different kind of holes that can be used for fixation with polyaxial angular stable locking screws or standard cortical screws. The DC-hole can be used for dynamic compression with a lag screw. As the case may be, the plates can be placed with a K-wire to fix the plate temporarily before the screws are tightened.

Intra-articular fractures, supracondylar fractures, osteotomies and non-unions of the distal humerus

The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is part of the LOQTEQ® Elbow System (K132787 and K140607), to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate-screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones. aap already offers a system of two plates for treatment of distal Humerus fractures: these are the anatomical shaped Plates LOQTEQ® Distal Dorsolateral Humerus Plate and LOQTEQ® Distal Medial Humerus Plate. Typically these devices are used together for one fracture and are placed under 90° orientation. The devices are already registered under the premarket notification K132787. Depending on the surgeons education some doctors prefer to use a different placement of the two plates. Therefore aap wants to add a further plate for the use in the identical intended use: this is the LOQTEQ® Distal Lateral Humerus Plate which is also used together with the LOQTEQ® Distal Medial Humerus Plate (see surgical approach above). In some rare indications this new device might be used as a standalone The anatomically performed plates are available as right and left version and in different lengths and with several shaft holes. The tapered end of the plate enables tissue-conserving, submuscular insertion. The tip of the shaft is tapered to allow a minimally invasive surgical technique. The bottom of shaft area is structured and tunnelled by cross grooves to minimize bone contact. All shaft holes, with the exception of the elongated hole are compatible with unidirectional locking screws as well as cortical screws. The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The round locking holes are suitable for locking screws as well as cortical screws. The locking screws allow evening catching very small fragments. The design of the so-called glide holes allows angle stable fixation and proximal compression of bone fragments at the same time if LOQTEQ® Cortical Screws are used. The use of standard cortical bone screws leads to a non-angle stable fixation. A compression of the bone fragments can be realised, if the screws are positioned eccentric inside the glide hole. If the screws are placed directly in the locking part of the gliding hole, no compression occurs. The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 consists of: LOQTEQ® Distal Lateral Humerus Plate, right/left, 2/3/5/7/11 holes LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 2.5, small head, T8, self-tapping Cortical Screw 3.5, self-tapping Set of Instruments aap LOQTEQ® Distal Lateral Humerus Plate

LOQTEQ® VA Distal Medial Tibia Plate 3.5: Fixation of complex intra- and extra-articular fractures of the distal tibia; osteotomies of the distal tibia LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5: Fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone LOQTEQ® VA Distal Fibula Plate 2.7/3.5: Fractures, osteotomies, and non-unions of the distal fibula, especially in osteopenic bone

The aap LOQTEQ® VA Distal Tibia Plate System consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures, osteotomies or non-unions. The system includes anatomically preformed and angle-stable small fragment plates, which are available as right and left versions as well as in different lengths. The geometrical shape of those plates is based on the anatomy and biomechanical stress of the distal tibia/distal fibula. A flat plate design, smooth transition of cross sections, chamfers and roundings preserve soft tissue irritation. The tapered tip of those shafts enable a minimal invasive surgery. For a minimization of the contact between bone (tibia) and plate, all holes of the shaft zone are tunneled and the bottom of the plates is structured. All plate holes, with exception of the oblong hole, are compatible with unidirectional locking screws as well as cortical screws. The use of locking screws is state of the art and particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The use as a conventional bone plate and screw osteosynthesis is also possible with standard cortical screws. The System incorporates: • LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5, right/left • LOQTEQ® VA Distal Medial Tibia Plate 3.5, right/left • LOQTEQ® VA Distal Fibula Plate 2.7/3.5, right/left • LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping • Cortical Screw 2.5, small head, T8, self-tapping • LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping • Cortical Screw 3.5, T15, self-tapping • LOQTEQ® Cortical Screw 3.5, T15, self-tapping • LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping

Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.

The aap Plate and Screw System LOQTEQ Distal Fibula Plates consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones. The Distal Fibula Plate System 3.5 is part of the LOQTEQ anatomic plate system. The anatomically preformed plates are available as right and left versions and in different lengths. The tapered end of the plate enables tissue-conserving, submuscular insertion. The 1.8 mm thin anatomic LOQTEQ Distal Fibula Plate 3.5 prevents skin and soft tissue irritation. All plate holes, with the exception of the oblong hole, are compatible with unidirectional locking screws as well as cortical screws (gold). The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The partially threaded Cancellous Screw dia 4.0 engages the remote bone fragment and slides through the bone fragment near the screw head. Thus, partially threaded screws enable interfragmentary compression. Washers in conjunction with aap screws are used to fixate small bone fragments. The aap Plate and Screw System LOQTEQ Distal Fibula Plates 3.5 incorporates: LOQTEQ Distal Fibula Plate 3.5, right and left. LOQTEQ Cortical Screw 3.5, small head, T15, self-tapping. Cortical Screw 3.5, T15, self-tapping. Cancellous Screw 4.0, small head, T15. Washer, I-Ø4.4, A-Ø8.0. Set of Instruments LOQTEQ Distal Fibula Plates 3.5. Material: All implants are made of Ti6Al4V (according ISO 5832-3 or ASTM F136). The surface of the plates is generated by an automatic slide finishing, the so-called "KeramoFinish". Those surfaces correspond to polished surfaces. The surface of the LOQTEQ Cortical Screws are slightly polished and anodised. The surface of the Cortical Screws are fine blasted and anodised as well.

The aap LOQTEQ® VA Volar Distal Radius Plate 2.5, LO- QTEQ® VA Distal Radius Straight Plate 2.5, LOQTEQ® VA Distal Radius L-Plate 2.5 are intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius . The aap LOQTEQ® VA Distal Ulna Plate 2.5, LOQTEQ® VA Distal Ulna Hook Plate 2.5 are intended for fractures and osteotomies of the distal ulna .

The aap LOQTEQ® VA Radius Set 2.5 consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures, osteotomies. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).