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General Indications: The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. Indications: - Primary and secondary osteoarthritis - Rheumatoid arthritis - Correction of functional deformities - Avascular necrosis - Femoral neck fractures - Revision after implant loosening dependent on bone mass and quality Dual Mobility Insert (in addition to the indications and general indications): - Dislocation risk The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell. Additional indications specific to the TrabecuLink Augments: - Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. MobileLink PlasmaLink and TiCaP Shells: The MobileLink System consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either titanium plasma sprayed (TPS) coating (brand name: PlasmaLink) or a double coating consisting of titanium plasma spray coating plus calcium phosphate (CaP) coating (brand name: TiCaP). The MobileLink PlasmaLink and TiCaP Shells are compatible with polyethylene liners (K182321, K241636), acetabular bone screws (K192559), Dual Mobility Inserts (K200607) with BiMobile Dual Mobility Liners (K171273, K190535), Shell/Insert Adapters ("Face Changers", K200607), and TrabecuLink Augments (K241636).

The MobileLink Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. Indications: - 1) Primary and secondary osteoarthritis - 2) Rheumatoid arthritis - 3) Correction of functional deformities - 4) Avascular necrosis - 5) Femoral neck fractures - 6) Revision after implant loosening dependent on bone mass and quality The MobileLink Dual Mobility Insert is additionally indicated for: 7) Dislocation risks Additional indications specific to the TrabecuLink Augments: Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies. The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. This 510k adds several system components to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607, and K222066. X-LINKed Inserts: The X-LINKed Inserts are manufactured from highly crosslinked polyethylene material. The inserts are available in the same sizes and designs as the previously cleared E-Dur inserts (K182321). The design variants include a neutral variant with or without offset, a shouldered variant with or without offset and 10° and 20° inclining variants with an offset. The inserts are fixed using a clamping system consisting of a combination of snap mechanism and conical clamping. Notches (tabs/recesses) at the rim further contribute to the rotational stability of the PE inserts. TrabecuLink Augments: The TrabecuLink Metal Acetabular Augments are wedgeshaped components that conform to the shape of the acetabular shell. They are additively manufactured Ti6A14V alloy per ISO 5832-3 (chemistry and mechanical properties) and feature a porous structure (TrabecuLink) on the bone interfacing surface. They mate with the same MobileLink (TrabecuLink) Shells as previously cleared in K182321 and K222066 and they can be used with the same 6.5mm diameter bone screws cleared in K192559, or with new smaller diameter (4.5mm) bone screws introduced in this submission. Bone Screws: The MobileLink Bone Screws are Ø 4.5mm in lengths from 15 -60mm (by 5mm increments). They feature the same head size/design as the previously cleared Ø 6.5mm screws and are made of the same wrought Ti6A14V alloy per ISO 5832-3 and ASTM F136 as the previously cleared Ø 6.5mm screws.

General Indications: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty. Indications: Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically and structurally suited to receive the implants. The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws. The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation. The Humeral Stems Standard without CaP (HX) are intended for cemented or cementless fixation. The Humeral Fracture Stems and Proximal Bodies are intended for cemented or cementless fixation. The Modular Stems 75mm are intended for cemented or cementless fixation. The Modular Stems, fully corundum blasted, are intended for cementless fixation. The Modular Stems, fully polished, are intended for cemented fixation.

This Line Extension portfolio includes: - Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutral designs and in wedged (10°, 15° and 20°) and lateralized variants (+3mm and +6mm). The new 25mm Ø RGB components include new peripheral 4.5mm Ø cortical screws in lengths of 20-60mm with a reduced head diameter as compared with the predicate 4.5mm Ø cortical screws cleared in K200368. The screws are available in standard and angle-stable/locking versions. - Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mm and +6mm lateralization. - Humeral Reverse Tray in a neutral (concentric) version with extended +5mm height.

General indications: Mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. Indications: 1) Primary and secondary osteoarthritis 2) Rheumatoid arthritis 3) Correction of functional deformities 4) Avascular necrosis 5) Femoral neck fractures 6) Revision after implant loosening dependent on bone mass and quality The MobileLink Dual Mobility Insert is additionally indicated for: 7) Dislocation risks The MobileLink Acetabular Shells are intended for cementless fixation.

This 510k adds MobileLink TrabecuLink Acetabular Shells to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607. These shells are additively manufactured from Ti6Al4V alloy per ISO 5832-3 and feature a porous structure (TrabecuLink) on the bone interfacing surface for biologic fixation. The shells come in cluster-hole and in multi-hole patterns. mate with the same UHMWPE liners (in conventional PE and highly-crosslinked vitamin E PE) as previously cleared in K182321, and with the same Dual Mobility Inserts and Shell/Insert Adapters previously cleared in K200607. They can be used with the same bone screws cleared in K192559.

General Indications: The LinkSymphoKnee is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: - Primary degenerative arthritis / osteoarthritis - Secondary arthritis resulting from rheumatoid arthritis - Fracture

The LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is available in cPE and E-Dur. In cases of good joint stability, where the ligaments and capsule are intact the FB UC version is available. This configuration is provided for PCL retaining joint reconstruction or if the posterior cruciate ligament is sacrificed. The Fixed Bearing Ultracongruent (FB UC) Articulating Surface is compatible with the already cleared LinkSymphoKnee (K202924). The LinkSymphoKnee is available in multiple versions with different applications, characteristics, and materials.

The SP-CL Hip Stem and LCU Hip System are indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The hip systems are indicated for the following conditions: - Primary and secondary coxarthrosis - Osteoarthritis - Necrosis of the femoral head - Femoral neck fractures The stems are indicated for cementless use only.

The submission includes a straight stem, LCU Hip Sytem, and an anatomically curved stem, SP-CL Hip Stem. Both stems are comprised of titanium alloy (Ti6A14V acc. to ISO 5832-3, ASTM F136) available with HX (CaP) (ASTM F1609) coating. The stems are available in a range of sizes, lengths, and offsets. In total hip replacement, the SP-CL Hip Stem and LCU Hip System are combined with a corresponding prosthesis head and the acetabular implant components manufactured by Waldemar Link. The change that is subject of this 510(k) is to add calcium phosphate coating (CaP) done by Waldemar Link inhouse to the above listed systems. The devices are already commercially available with CaP coating applied by an external vendor. There is no change to the fundamental scientific technology of the referenced hip systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufactured. All components are sterile and for single use only.

Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. Femoral neck fractures. Correction of functional deformities.

The Vario-Cup System consists of an UHMWPE component encased in an ultra-smooth polished EndoDur (CoCrMo) outer metal casing, for articulation in the bony acetabulum. It is to be used in conjunction with femoral components of the LINK Total Hip Systems. The 22 mm inner diameter Vario-Cup Prostheses are available in outer diameters ranging from 39-43 mm in 1 mm increments. Vario-Cups are self-centering which provides for a functional view of their position in post-op X-rays. An anti-luxation feature resists dislocation: an UHMWPE Safety Ring is placed in a groove at the entrance of the polyethylene insert after assembly of Vario-Cup and femoral components.

The BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects of hip joint or proximal femur, which cannot be treated by conservative or osteosynthetic procedures. The BiMobile Dual Mobility System is indicated for the following conditions: - · Primary and secondary coxarthrosis - Rheumatoid arthritis - · Correction of functional deformities - · Avascular Necrosis - · Femoral neck fractures - · Revision after implant loosening dependent on bone mass and quality - · Dislocation risks The device is intended for cemented and cementless use.

The BiMobile instruments are considered a line extension to the instrument system cleared in 510(k) K171273 and K190535 with the BiMobile Dual Mobility System. Like the original instruments, the additional BiMobile instruments are manual orthopedic surgical reusable instruments offered to aid the implantation of the BiMobile Dual Mobility System (K171273 and K190535). The BiMobile Instruments incorporate design changes for simplicity of use. The modifications do not significantly alter the surgical workflow or technique, the intended use, or involve any change in technology.

General Indications LINK Endo-Model EVO Knee System: The LINK Endo-Model EVO Knee System is intended for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or os- teosynthetic procedures. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: All LINK Endo-Model EVO components: - · Primary and secondary osteoarthritis. - Rheumatoid arthritis. - · Revision after primary or revision total knee replacement. - · Bone necroses which won't compromise the successful implantation of a hinged total knee endoprosthesis. - · Varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers. The LINK Endo-Model EVO Pure Hinge is additionally indicated for: · Extreme cases of varus/valgus deformities (20-30°), theumatoid arthritis, muscular deficiency and any kind of genu laxum. · Oncological and revision surgery in lower limb (in conjunction with the Endo- Model EVO -W and the Megasystem-C) The LINK Endo-Model EVO Rotating Hinge is additionally indicated for: · Oncological and revision surgery in lower limb (in conjunction with the Endo- Model EVO - W and the Megasystem-C) General Indications Link OptiStems: The Link OptiStems are for use with the following LINK knee femoral components, both intracondylar and distal femoral replacement versions: LINK Endo-Model SL. LINK Endo-Model EVO-M. and LINK Endo-Model EVO-W and are indicated for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. The Link OptiStems cemented are intended for cemented use only. The Link OptiStems cementless are intended for cementless use only. Indications: · Revision arthroplasty due to juxta-articular bone defects. - · Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture. - · Bone deficiencies, e.g. due to tumors, as well as in large post-revision and posttrauma segmental bone defects. · Oncological and revision surgery in the area of the distal femur (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses or LINK Endo-Model EVO - M/ - W).

The LINK Endo-Model EVO Knee System is available in multiple versions with different applications, characteristics, and materials. The LINK Endo-Model EVO is a constrained total knee prosthesis, which is based on the previously cleared LINK Endo-Model Knee System (K143179, K152431, K212742), and is considered an evolution ('EVO') of the previous designs. The Knee System is available in two different hinge designs - Rotating Hinge and Non- rotating (Pure) Hinge. Also like the previously cleared system, the subject LINK Endo- Model EVO is available in two versions - LINK Endo-Model EVO Standard and LINK Endo-Model EVO - Modular. The femoral and tibial components of the standard version have fixed stems while the femoral and tibial components of the modular system are available with stems having a taper connection. The modular system includes femoral components with either a male taper or a female taper, and are designated as LINK Endo-Model EVO-M (male taper) and Endo-Model EVO-W ("weiblich" = female taper). The LINK Endo-Model EVO - Standard consists of a cemented monoblock femoral component made from CoCrMo and cPE and a cemented monoblock tibial component made from CoCrMo and an articulating surface made from cPE. The Standard System is available in Rotating Hinge or Pure Hinge. The LINK Endo-Model EVO – M consists of a cemented modular femoral component made from CoCrMo, Ti6A14V (Tilastan) and cPE and a cemented modular tibial component made from CoCrMo, Ti6Al4V (Tilastan) and an articulating surface made from cPE and with modular stems, cemented made from CoCrMo or cementless made from Ti6Al4V (Tilastan). The Modular System is available in Rotating Hinge or Pure Hinge. The LINK Endo-Model EVO – W intracondylar and condylar replacements consists of a cemented modular femoral component made from CoCrMo, Ti6Al4V (Tilastan) and cPE and a cemented modular tibial component made from CoCrMo, Ti6Al4V (Tilastan) and an articulating surface made from cPE and with modular stems, cemented made from CoCrMo or cementless made from Ti6Al4V (Tilastan). The Modular System is available in Rotating Hinge or Pure Hinge. The femoral components can be used with distal and femoral (straight and L-shaped) segments made from Ti6A14V (Tilastan). The modular tibial components can be used with tibial spacers made from Ti6Al4V (Tilastan). The femoral and tibial components Rotating Hinge versions are also available in LINK PorEx (TiNbN) coated version. Additionally a 3-peg patella can be used with the LINK Endo-Model EVO Knee System. It is made from cPE. The LINK Endo-Model EVO Knee System femoral and tibial components are compatible with the previously cleared LINK Endo-Model Knee System (K143179, K152431 and K212742). The femoral components of the LINK Endo-Model EVO – W are compatible with the previously cleared LINK MEGASYSTEM-C (K151008). The LINK Endo-Model EVO Knee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364). The Link OptiStems are an expansion of the modular stem portfolio. The Link OptiStems consist of a modular stem, adapter and fixation screw. The Link OptiStems come in cemented and cementless version. The Link OptiStems have to be joined and implanted in combination with the Femoral Components of LINK Endo-Model SL (K151008) or LINK Endo-Model EVO – M / -W.

The MP Reconstruction System is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The MP Reconstruction System is indicated for the following conditions: 1. Revision arthroplasty due to juxta-articular bone defects. 2. Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone. 3. Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture. 4. Deformed proximal femur due to fractures or osteotomies. 5. Correction of bone deficiencies, e.g. due to tumors. 6. Large post-revision and post-trauma segmental bone defects. The MP Reconstruction System is for cementless use. Only cemented labeled modular stems are indicated for cemented use.

This 510k adds Cemented Stems to the MP Reconstruction System. The MP Reconstruction System is a modular hip prosthesis system and consists of Prosthesis Heads, Stems, Neck Segments, Proximal Spacers, and Expansion Bolts. The modular components are interchangeable allowing for independent positioning. The Prosthesis Stems are available in a variety of diameters and lengths. Neck Segments are available in a variety of CCD angles and sizes. Proximal Spacers are available in two different heights and can be used independently or combined to add leg length. Expansion Bolts are used to secure the Neck Segments and Proximal Spacers, when used, to the Prosthesis Stems. The cementless prosthesis stems are tapered with a microporous surface, and include longitudinal fluting. The cemented prosthesis stems have a rounded triangular shape with an anatomic bow at the distal tip. The MP Reconstruction Prosthesis Stems (cementless) and Neck Segments are produced of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). Cemented Stems, Proximal Spacers and Expansion Bolts are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.