(104 days)
The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Frag System, Long Bone Fracture System, and Ankle Fracture/ Fusion System with the following indications:
Mini-frag System:
The Tyber Medical Mini-Frag is indicated tor fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The mini-frag system is also infended for reduction and stabilization of non-bad bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use.
Foot System
The Tyber Medical Foot System is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions of short bones and small fragments of bone in the foot (Phalanges and Metatarsals), and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) in an adult patient. The Tyber Medical Foot System is not for Spinal Use.
Long Bone Fracture System
The Tyber Medical Long Bone Fracture System is indicated for fixation of fractures, ostectomies, nonunions, replantations, and fusions of the clavicle, scapula, olecranon, huma, fibula. The Tyber Medical Long Bone Fracture System is not for Spinal Use.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is indicated for use in:
· Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, nonunions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
• In intra- and extra articular fractures, medial malleolar fractures and nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
• In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use.
The Tyber Medical Anatomical Plating System consists of the following categories:
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- Mini-frag System
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- Foot System
- Long Bone Fracture System
- Ankle Fracture/Fusion System
A brief and concise description of each system is as follows:
Mini-frag System
The Tyber Medical Mini-frag System offers a variety of bone fragments. The system incorporates a series of standard and locking compression plates and screws of varying lengths, thicknesses, and configurations including 1). Straight Fracture Plates, 2). T-shape Fracture Plates, 3). Y-shape Fracture Plates, 5). Cloverleaf plates, 6). Straight Fusion Plates, 7). Oblique Fracture Plates, 8). Oblique Fracture Compression Plates, 10). Zig-Zag Plates, 10). Zig-Zag Plates, 12). Mesh Plates
The System will incorporate both Locking Screws and Non-Locking Screws in 2.0mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary instrumentation is available with the system. The Tyber Medical Mini-frag/Small Bone sterile and non-sterile for single-use.
Foot System
The Tyber Medical Foot System consists of a variety of plates with shapes and sizes designed for internal fixation of short bone fragments of the foot. The implants are designed to provide highly anatomic and versatile options and stabilizations of small bones in the feet. The plates are available in various lengths, with straight, right and left configurations. Plate types consist of 1). TMT-1 Fusion Plates, 2). Open Wedge Plates, 3). Navicular Plates, 5). Lateral Talar Neck Plates, 6). Akin Plates, 7). 5th Metatarsal Jones Fracture Plates, 8), 5th Metatarsal Fracture Compression Plates, 9), 5th Metatarsal Avulsion Fracture Plates, 10). Medial Talar Neck Plates, 11). Distal Medial Column Plates, 13). ORIF Standard Calcaneal Plates, 14). Rectangular Plates, 15). X-Plates, 16). Cotton Plates, 17). Dwyer Plates, 19). MTP Fusion Revision Plates, 20). Stepped Lapidus Plates, 21, Plantar TMT Plates, 22). Medial Column Plates, 24, TMT-I Medial Fusion Plates, 25). Sinus Tarsi Plates, 26). 1st 2nd Ray Lisfranc Joint Plates, 27). 2nd and 3rd Ray Lisfranc Joint Plates, 28). Navicular Cuneiform Plates, 30). Talonavicular Plates.
The system will incorporate both locking and Nor-locking screws. All plates are composed of T-6A-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Foot System is offerile and non-sterile for single-use.
Long Bone Fracture System
The Tyber Medical Long Bone Fracture System consists of a straight low contact locking plate and a 1/3 locking tubular plate. The system will incorporate both Cortical locking and standard Cortical Non-locking screws. All plates are composed of Ti-6Al-4VELL (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of T-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Long Bone Fracture System is offered both sterile and non-sterile for single-use.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system is composed of various locking plate types which include 1). Posterior Tibia Plate, 2). Fibula Plate, 3). Medial Tibia Plate, 5). Anterolateral Tibia Plate, 7). Medial Malleolus Plate, 7). Medial Malleous Plate, 8). Fibula Hook Plate, Straight, 9). Fibula Hook Plate, Anatomic, 10). Anterior TT Plate, 12). Anterolateral TT Plate, 13). Lateral TT Plate, 14). Lateral TTC Plate, 15). Posterior TTC Plate, 17). Posteromedial Tibia Plate, 18). Trimalleolar Plate, 19). Trimalleolar Plate, 19, Posterior Fibular Plate.
The System will incorporate both Locking Screws and Non-locking Screws in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile for single-use.
The provided document is a 510(k) summary for the Tyber Medical Anatomical Plating System, which is a medical device for bone fixation. However, it does not describe any acceptance criteria or a study proving the device meets those criteria.
Instead, the document states:
- "This traditional 510(k) is being completed to update the indications for use of the Tyber Medical Anatomical Plating System." (Page 4)
- "There are no new implants or instruments being added to the system and no changes to the design, functionality, and application of the devices that make up the system cleared under K222465." (Page 4)
- "There are no design, functionality, performance or technological changes to the devices that make up the Tyber Medical Anatomical Plating System." (Page 6)
- "This submission is for an indication change only to the Tyber Medical Anatomical Plating System. There are no changes to the devices, and therefore, there is no change in performance of the device. No new implants are being introduced in this submission. These devices remain the same as the devices cleared from K222465." (Page 6)
- "No clinical testing was performed." (Page 6)
Therefore, based on the provided text, there is no information available regarding:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number or qualifications of experts used for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The submission is for an expanded indication for use of an existing device, asserting substantial equivalence to previously cleared predicates without new performance testing, as no design, functionality, or performance changes were made to the device itself.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.