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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: - **Non-inflammatory degenerative joint disease including** - osteoarthritis - traumatic arthritis, and - avascular necrosis (not applicable to Physica TT Tibial Plate); - **Inflammatory degenerative joint disease including rheumatoid arthritis;** - **Correction of functional deformity;** - **Revision procedures where other treatments or devices have failed; and** - **Treatment of fractures that are unmanageable using other techniques.** **Additional indications for Physica LMC component are:** - Moderate varus, valgus, or flexion deformities. In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for: - **Absent or not-functioning posterior cruciate ligament;** - **Severe antero-posterior instability of the knee joint.** **Additional indications for Physica HPS component are:** - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - 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. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Moderate varus, valgus, or flexion deformities. Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use. Tibial liners can be used with cemented or uncemented tibial or femoral components.

This 510(k) submission aims at introducing the Physica CR Porous Femoral components as part of the subject Physica system. The subject device components are intended to be used without cement, articulating with other components of the cleared Physica system. The Physica system (including subject Physica CR Porous Femoral components) is intended for a total knee replacement. Physica CR Porous Femoral components are designed based on the cemented Physica CR Femoral components already cleared (K151266). They are made of CoCrMo (ISO 5832-4 / ASTM F75) and are intended to replace the condyles of the distal femur. The femoral components are available in ten sizes (left and right) and are intended to replace the condyles of the distal femur. The femoral components are available in left and right versions and have an asymmetric anterior flange (to adapt left and right knees) with symmetric condyles for the articulation with the tibial liner.

Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: - · Non-inflammatory degenerative joint disease including o osteoarthritis o traumatic arthritis, and o avascular necrosis (not applicable to Physica TT Tibial Plate); - · Inflammatory degenerative joint disease including rheumatoid arthritis; - · Correction of functional deformity: - · Revision procedures where other treatments or devices have failed; and - · Treatment of fractures that are unmanageable using other techniques. Additional indications for Physica LMC component are: - · Moderate varus, valqus, or flexion deformities. In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for: - · Absent or not-functioning posterior cruciate ligament; - · Severe antero-posterior instability of the knee joint. Additional indications for Physica HPS component are: · Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - · 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. - · Collagen disorders, and/or avascular necrosis of the femoral condyle. - · Moderate varus, valgus, or flexion deformities. AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.

Physica Porous Femoral Components have been cleared via K210554 with a Porous coating performed by a supplier. With this 510(k) submission, Limacorporate intends to add an additional coating vendor for these components. No other change is introduced on the Physica Porous Femoral Components: Intended use, design, material, sterilization, packaging and principle of operation are unchanged compared to the information approved in K210554.

AMF TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

The AMF TT Cones are intended to be used as an optional accessory component in total knee arthroplasty. The AMF TT Cones are one-piece devices, made from Ti6A14V alloy, conically shaped with cannulation all the way through the cone. With this 510(k) submission, the compatibility of the AMF Revision TT Cones (K200653) with the EMPOWR Revision Knee (K230169) manufactured by Encore Medical, L.P. is introduced.

The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon. The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to: - . Non-inflammatory degenerative joint disease (i.e. osteoarthritis), - Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis, . - Avascular necrosis of the humeral head, ● - . Traumatic/post-traumatic arthritis, - Fractures of the humeral head where adequate fixation can be achieved and adequate bone . stock remains, - . Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains, - . Cuff tear arthropathy (CTA Heads only). The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy). Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses. The PRIMA reverse implant is indicated for patients suffering from pain and disability due to: - Rotator cuff tear arthropathy, - Osteoarthritis with rotator cuff tear, - Rheumatoid arthritis with rotator cuff tear, - Massive irreparable rotator cuff tear, - Avascular necrosis of the humeral head, - Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains, The PRIMA Glenoid System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

This 510(k) submission aims at introducing new components to the previously cleared PRIMA Humeral (K212800) and Glenoid (K222427) systems. The PRIMA Short Stem Plus is introduced as part of the PRIMA Humeral System. As the already cleared PRIMA Short Stem, the PRIMA Short Stem Plus is a convertible short stem component with proximal (metaphyseal) fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the stem component can be coupled with an Adaptor for the humeral heads for the anatomic configuration and with a Reverse Tray and Reverse Insert in reverse configuration. The PRIMA Short Stem Plus is intended for use in cementless and cemented applications. The PRIMA Short Stem Plus is made of Ti6A14V (ISO 5832-3) and is available in two different lengths: 86 mm and 96 mm. Each length is available in seven different sizes, varying from 28mm to 40mm in the proximal diameter. The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20mm are introduced as part of the PRIMA Glenoid System, as an additional option to the already available sizes (length 25 to 50mm), cleared via K222427. The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws are intended to be inserted in the central hole of the glenoid baseplate and are used to fix the PRIMA TT Glenoid baseplates to the glenoid bone. As for the already cleared central compressive screws of PRIMA TT Glenoid, the PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20 mm are manufactured from Ti6A14V (ASTM F1472, ISO 5832-3) and have respectively diameter 5mm (cortical) and 6.5mm (cancellous).

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: - non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ● - inflammatory degenerative joint disease such as rheumatoid arthritis; ● - treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; - . revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains; - cuff tear arthropathy (CTA Heads only); - glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid ● Glenoid only). The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed. The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

The SMR Hybrid Glenoid System (K223876) is a modular system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a SMR Hybrid Glenoid component to be used in anatomical shoulder configuration and a reverse baseplate with screws and glenosphere that are used in reverse shoulders. The SMR Hybrid Glenoid is a cemented glenoid component composed of a polyethylene baseplate connected to a central peg made of Trabecular Titanium. The baseplate has two peripheral pegs intended to be cemented into the native glenoid with the central peg being uncemented. The SMR Hybrid Glenoid is available in different sizes of baseplate and peg. If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the anatomic polyethylene baseplate and leaving the metal peg in place. A metal SMR Hybrid Glenoid Reverse Baseplate is then connected to the central peg and a SMR Glenosphere coupled to the metal SMR Hybrid Glenoid Reverse Baseplate to articulate with a SMR Reverse Shoulder humeral liner, body and stem assembly on the humeral side. The metal SMR Hybrid Glenoid Reverse Baseplate and central porous peg assembly is intended for uncemented use with the addition of screws for fixation in reverse shoulder reconstructions. This 510(k) is to introduce Selective Laser Melting (SLM) as a manufacturing option for central peg comprised of Trabecular Titanium. The subject device peg, made by SLM, has the same design of the predicate SMR Hybrid Glenoid System (K223876) and features the same net on the external surface.

The MINIMA S System stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the MINIMA S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the MINIMA S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: · non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dvsplasia: · rheumatoid arthritis; · treatment of femoral head and neck fracture; · revisions in cases of good remaining femoral bone stock.

The MINIMA S System is intended for partial or total hip arthroplasty in cementless use. It is a monolithic collarless stem currently available in 9 sizes (sizes from 4 to 12) in standard and lateralized versions. This Special 510(k) is to introduce Size 3 of the stem. Also this size comes in a standard and a lateralized version. The Minima S stem is made of Ti6Al4V, and it has a plasma sprayed titanium coating in the proximal area (ASTM F1472, ISO 5832-3). The stem is characterized by a 12/14 conical taper to be coupled to LimaCorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads.

The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to: · non-inflammatory degenerative joint disease including osteoarthritis; • revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant); · glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only). The SMR Stemless Anatomic is intended for uncemented use.

The SMR Stemless Anatomic is a modular system comprised of a stemless core and humeral head adaptor taper. The modular components are available in various sizes and are interchangeable allowing for independent sizing and positioning. The SMR humeral heads were previously cleared (K161476, K100858), and the SMR Stemless Anatomic is compatible with the previously cleared Cemented SMR metal back Glenoid Components (K113254, K133349, K143256), Cemented SMR all polyethylene glenoid components (K100858, K130642, K153722), and SMR TT Hybrid Glenoid System (K163397).

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: - non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - inflammatory degenerative joint disease such as rheumatoid arthritis; ● - treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; - revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains); - . cuff tear arthropathy (CTA Heads only); - glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid ● Glenoid only). The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient ioint with severe arthropathy (disabled shoulder). The patient's ion t must be anatomically suited to receive the selected implants and a functional deltoid muscle is neces sary to use the device. The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The SMR Shoulder System is a complete system intended to be used in primary or revision total shoulder joint replacement in either anatomic or reverse configurations. The SMR Shoulder System was cleared via several 510(k) submission, up to the latest approval under K220792. The new compatibilities introduced with this 510(k) are related to the system when used in reverse shoulder configuration only. The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The SMR Shoulder System in reverse configuration consists of humeral stems, reverse humeral bodies, reverse liners, glenospheres, metal back glenoid components and pegs. The metal back glenoid component, when used as part of a reverse shoulder replacement, is intended for cementless fixation with bone screws. Glenoid components of the SMR Shoulder System are cleared for use also with the humeral components of the PRIMA Humeral System (K212800). When used in combination with the PRIMA Humeral System, the device consists of a humeral stem, tray, reverse insert, glenospheres, metal back glenoid components and pegs. With this Traditional 510(k) submission, new compatibilities between already cleared devices of the SMR Shoulder System are introduced: - Bone Screws dia. 5.0 mm (K210717) compatible with SMR Metal Back Glenoid -(K113254) and SMR TT Baseplate (K133349); - -SMR TT Hybrid Glenoid Reverse Baseplate (K163397) compatible with SMR Glenosphere dia. 42 mm (K212800). No changes in indications for use, materials, manufacturing processes, packaging and sterilization are introduced with this 510(k) on already cleared devices.

Smart SPACE Shoulder 3D Positioners and Anatomical Models The Smart SPACE Shoulder 3D Positioners and Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to to transfer a pre-operative plan into surgery, designed on the basis of patient-specific pre-operative CT scans. The Smart SPACE Shoulder 3D Positioners are intended, by quiding the surgical instruments in some steps of the orthopedic surgical procedure, to prepare the bone to host the implantable components. The Smart SPACE Shoulder Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the surgeon. The model is intended to be used to check that the 3D Positioner(s) is properly placed on the anatomical compartment. These devices must be exclusively utilized by an orthopedic surgeon who has a good knowledge of the specific operative technique. Smart SPACE Shoulder 3D Positioners and Anatomical Models are indicated for use on adult patients that are candidates for primary elective reverse and anatomic total shoulder arthroplasty. Smart SPACE Shoulder Planner Smart SPACE Shoulder Planner is a medical device for surgeons component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. Smart SPACE Shoulder Planner does not include any system to manufacture the shoulder patient-specific instrumentation. Smart SPACE Shoulder Planner is intended to be used by an orthopedic surgeon, with clinical experience in shoulder replacement surgery to make decisions regarding implant position, orientation and sizing. Smart SPACE Shoulder Planner is intended to be used for adult patients planning only. The Smart SPACE Shoulder Planner is intended for use with patients that are candidates for primary reverse and anatomic total shoulder arthroplasty. The specific functionalities of the Smart SPACE Shoulder Planner version are described in the User Manual and Quick Start Guide provided by LimaCorporate.

The Smart SPACE Shoulder Planner consists of a software which assists the user in planning anatomic total or reverse shoulder arthroplasty. It provides the user to select surgical execution using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance. The Smart SPACE Shoulder system was cleared by TechMah Medical via K202151, K202454. K191247, and it includes the Smart SPACE Shoulder Planner, the Cubit Guidance system, the 3D Humeral and Glenoid Positioners and the Anatomical models. TechMah Medical became part of Limacorporate S.p.A in 2021. With this registration, LimaCorporate aims to: - introduce an upgrade of the Smart SPACE Shoulder Planner; - - introduce the Smart SPACE Shoulder 3D Positioners and Anatomical Models manufactured by LimaCorporate, that are provided non-sterile.