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510(k) Data Aggregation
K Number
K241754Device Name
NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate
Manufacturer
Zimmer Switzerland Manufacturing GmbH
Date Cleared
2024-08-15
(58 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Zimmer Switzerland Manufacturing GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NCB® Polyaxial Locking Plate System:
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of distal femoral (NCB DF), proximal humeral (NCB PH), and proximal tibial (NCB PT) fractures and osteotomies.
NCB® Periprosthetic Femur Plate System:
The NCB Periprosthetic Femur Plate System is indicated for temporary internal fixation and stabilization of femoral fractures and osteotomies, including periprosthetic fractures.
If combined with the NCB Periprosthetic Trochanter Plate and Connection Screw, the NCB Periprosthetic Proximal Femur Plate is additionally indicated for temporary internal fixation and stabilization of greater trochanter fractures and osteotomies including re-attachment of the greater trochanter following fracture and osteotomy in total hip arthroplasty.
The NCB Periprosthetic Trochanter Plate and Connection Screw can only be used in combination with the NCB Periprosthetic Proximal Femur Plate.
NCB® Cable Button:
The NCB Cable Button for the NCB Polyaxial Locking Plate System in combination with the Zimmer Biomet NCB Polyaxial Locking Plate System and Cable-Ready System Cerclage Cables is indicated for temporary internal fixation of fractures and osteotomies.
NCB® Straight Narrow Shaft Plate
The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including periprosthetic fractures.
Device Description
NCB® Polyaxial Locking Plate System
The NCB (Non-Contact-Bridging) Polyaxial Locking Plate System is a plate solution intended for the treatures and osteotomies of the distal femur (NCB DF), proximal humerus (NCB PH) and proximal tibia (NCB PT). NCB plate holes allow for polyaxial screw placement (30° cone) with subsequent screw locking, the screws can act as lag screws and be used for fracture reduction. In the locked mode, the plates act as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment.
An additional extension tuberculum minus plate can be assembled to the humeral plate with cerclage wire technique for fixation of anteroposterior (AP) tuberculum minus fractures. NCB femoral, humeral and tibial plates, cortical, cancellous and cannulated screws, locking cap, blind screw inserts and spacers are made from titanium alloy Protasul®-64 (Ti-6Al-4V - ISO 5832-3/ASTM F136). The tuberculum minus plate is made from cpTi (ISO 5832-2/ASTM F67), cortical screws from titanium alloy Protasul-100 (Ti-6Al-7Nb ISO 5832-11/ASTM F1295) and the cerclage wire from 1.4441 stainless steel Protasul-S (ISO 5832-1/ASTM F138-F139).
NCB® Periprosthetic Femur Plate System
The NCB (Non-Contact-Bridging) Periprosthetic Femur Plate System is a line of polyaxial locking plates for the treatment of femoral fractures, particularly of periprosthetic femoral fractures. The system consists of Proximal Femur Plates, Curved Shaft Plates, Trochanter Plates and a Connection Screw. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Periprosthetic Plate acts as an internal fixator without contact between the bone suface, reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.
Additionally, within this system, the NCB Periprosthetic Trochanter Plates used in combination with the NCB Periprosthetic Proximal Femur Plates for the treatment of proximal femoral fractures, which includes greater trochanter fractures and osteotomies. The Connection Screw for NCB Periprosthetic Trochanter Plate is used to attach the Proximal Femur Plate. The NCB Periprosthetic Trochanter Plates contain threaded conical holes which allow for monoaxial screw placement using locking screws with threaded heads. Non-locking cortical screws can also be used.
The NCB Periprosthetic Proximal Femur Plates are available in five lengths (Length=245mm, 324mm, 363mm, 401mm) which can be used either as standalone implants or in combination with the NCB Periprosthetic Trochanter Plates. The NCB Periprosthetic Proximal Femur Plate short (Length=115 mm) is used only in combination with the NCB Periprosthetic Trochanter Plates. The NCB Curved Shaft Plates are also included in the NCB Periprosthetic Femur Plate System and are specifically designed for the femur. The Proximal Femur Plates, Distal Femur Plates, Trochanter Plates and Connection Screw are made of a titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3).
NCB Cable Button for NCB Polyaxial Locking Plate
The NCB (Non-Contact-Bridging) Cable Button for NCB Polyaxial Locking Plate is a temporary internal fixation component used in conjunction with Zimmer Biomet NCB Polyaxial Locking Plate System Cerclage Cables. The Cable Button is threaded into a vacant screw hole of the Zimmer Biomet NCB Polyaxial Locking Plate System and provides a positioning point for a Cerclage Cable.
The Cable Button is made of titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3) and has a color anodization (Type III).
NCB Straight Narrow Shaft Plate
The NCB (Non-Contact-Bridging) Straight Narrow Shaft Plate is a line of polyaxial locking plates for the treatment of humeral and tibial shaft fractures, including periprosthetic fractures. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Straight Narrow Shaft Plate acts as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment. This Non-Contact-Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.
The NCB Straight Narrow Shaft Plate is made of Titanium alloy [Ti6Al4V (Protasul®-64WF) ISO 5832-3].
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K Number
K231114Device Name
Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System
Manufacturer
Zimmer Switzerland Manufacturing GmbH
Date Cleared
2023-08-09
(112 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
Zimmer Switzerland Manufacturing GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) are intramedullary nails intended for temporary internal fixation and stabilization of femoral fractures or osteotomies. Indications for the Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) include:
- · Compound and simple shaft fractures.
- · Proximal, metaphyseal and distal shaft fractures.
- · Segmental fractures.
- · Comminuted fractures.
- · Fractures involving osteopenic and osteoporotic bone.
- · Pathological fractures.
- · Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union and delayed union.
- · Periprosthetic fractures.
- · Surgically created defects such as osteotomies.
- · Intertrochanteric and subtrochanteric fractures.
The Affixus Natural Nail Humeral Nails are intramedullary nails intended for temporary internal fixation and stabilization of humeral fractures or osteotomies.
- The Affixus Natural Nail Humeral Nail System is indicated for use in a variety of fractures, such as:
- · Proximal fractures (proximal short and long nails only).
- · Diaphyseal fractures (proximal long nails and antegrade/retrograde nails only).
- · Open and closed fractures.
- · Comminuted fractures.
- · Nonunions and malunions.
- Pathologic fractures.
Device Description
The Zimmer Natural Nail System Cephalomedullary Nails are intramedullary nails designed to restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. A set screw (with a polyethylene peg) allows guided rotational stability of the lag screw. Nails, nail caps and screws are made from Tivanium Ti-6Al-4V Alloy. Set screws are made from Tivanium Ti-6Al-4V Alloy and Polyethylene (PE). Selected components of the Zimmer Natural Nail System are color coded to aid in identifying which components should be used together. The package label for each of the nails indicates which screw sizes should be used with that nail. Each section contains the color name that matches the color/color name on the label of the appropriate screw size for that section. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Zimmer Natural Nail System components.
The Affixus Natural Nail Humeral Nail System consists of temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. The nails restore the shape of preinjured bone and they are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.
The Ante/Retrograde Humerus Nails, Ante/Retrograde Humeral Nail Caps, Proximal Humerus Nail Caps, Washers, Cortical Bone Screws, and Blunt Tip Screws are made of Titanium alloy [Protasul®-64WF (Ti-6Al-4V) ISO 5832-3/ASTM F136] and Proximal Humerus Nails are made of Titanium alloy [Protasul-64WF (Ti-6AI-4V) ISO 5832-3/ASTM F136] and C.P Titanium [Protasul®-Ti ISO 5832-2/ASTM F67].
Package labels indicate the material of each component. Selected components of the Affixus Natural Nail Humeral Nail System instruments are color coded to aid in identifying which components should be used together. Refer to the surgical techniques for more detailed instructions on the use of Affixus Natural Nail Humeral Nail System components.
The purpose of this traditional bundled 510(k) is to update the Instructions for Use (IFU) and labels of the Zimmer® Natural Nail® System Cephalomedullary Nails and Affixus® Natural Nail® Humeral Nail System to include MR Conditional labeling. Additionally, to harmonize the content format of the IFU, some chapters of the IFUs are reorganized.
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K Number
K212129Device Name
Persona® Personalized Knee System
Manufacturer
Zimmer Switzerland Manufacturing GmbH
Date Cleared
2021-09-28
(82 days)
Product Code
JWH, MBH, OIY
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
Zimmer Switzerland Manufacturing GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
When a kinematic alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.
Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, stem extension, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Device Description
The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Personalized Knee System includes surgical instrumentation that facilitate implantation of the above described implant components.
The purpose of this submission is the introduction of an optional alternative surgical technique for distal femoral resection that enables for gap balancing and femoral external rotation, accomplished via the use of a new instrument platform including a femoral rotation guide and anterior-posterior cutting blocks. The resection of the proximal tibia is performed in accordance with the standard Persona Primary Knee Surgical Technique.
The new instruments do not change the intended use or fundamental scientific technology of the Persona Personalized Knee System components.
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