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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.

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 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.

TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to: 1. Elbow joint destruction which significantly compromises the activities of daily living 2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia. 3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain 4. Revision where other devices or treatments have failed. 5. Correction of severe functional deformity. 6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement. 7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations. TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies. The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly. The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies. TEMA Elbow system - Line extension introduces two new sizes of Ulnar stems to the ulnar stem range already cleared; moreover, a design change is introduced for the axle component, ulnar body component and for the humeral body compared to the original cleared version.

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.

The PRIMA TT Glenoid, that is part of the PRIMA Glenoid System, is a modular shoulder system intended to be used in combination with the previously cleared humeral components of the SMR Shoulder System (K220792) and PRIMA Humeral System (K212800). The new system components include a monoblock glenoid baseplate, a modular glenoid baseplate and the related glenoid peg, a glenosphere connector with screw, central and peripheral bone screws and locking caps. The baseplates are provided in different angulations, ranging between 10° and 20°, and in different offsets, up to +4mm lateralization. The glenosphere has articular diameter 36, 40 and 42mm and the connector with screw is available in low, medium and high lateralization. Central compressive screws are available in dia. 5 and 6.5mm and in length ranging between 25 and 50mm, while peripheral screws are available in dia. 5mm and in length ranging between 18 to 50mm. Baseplates, peg, screws and locking cap are made of Ti6Al4V, the glenosphere is made of CoCrMo and the glenosphere connector with screw is made of Ti6Al4V and UHMWPE.

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.

SMR Reverse Liners are made from LimaVit (cross-linked ultra-high molecular weight polyethylene with Vitamin E) conforming to ISO 5834-2, ASTM F648 and ASTM F2695. SMR Reverse Liners are coupled to SMR Reverse Humeral Bodies (K110598, K201905), with or without the use of the SMR Humeral Extension (K113523), and articulates with the SMR Glenosphere (K110598, K142139, K163397). SMR Reverse Liners have an articulating surface diameter of 36 mm and 40mm to articulate with the same diameter glenospheres respectively.

PRIMA Humeral System: The PRIMA humeral system is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. 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 PRIMA Stem is 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 Stem is intended as conversion surgery from anatomic to reverse, where the PRIMA 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, - Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains. The PRIMA Humeral System consists of the following single use components: - Anatomic configuration: - stem - adaptor for humeral heads. - Reverse configuration: - stem - reverse tray and - reverse insert. The PRIMA Humeral System is intended to be used with all SMR glenoids implants. SMR Glenosphere Ø42: 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 and structurally 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. In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented. The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct. On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The PRIMA Humeral System is the subject of this 510(k) and includes the SMR Glenosphere Ø42. The PRIMA Stem is a convertible short stem component with proximal fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the short stem component (Ti6Al4V) can be coupled with an Adaptor for the humeral heads (Ti6Al4V) in case on anatomic system and with a Reverse Tray (Ti6Al4V) and Reverse Insert (LimaVit E UHMWPE Ti6A14V ring) only in case of reverse. The PRIMA Stem is intended for use in cementless and cemented applications, at the discretion of the surgeon. When used in reverse configuration, the PRIMA Stem is coupled with a Glenosphere through a Reverse Tray and a Reverse Insert. PRIMA Stem is compatible with already cleared SMR Glenospheres Ø36 and Ø40 (K110598, K163397). In addition, PRIMA Stem is compatible with the new SMR Glenosphere Ø42 (CoCrMo), subject of the present 510(k).