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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

The proposed Exactech Alteon HA Femoral Stems are intended for press-fit hip arthroplasty. The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V ELI (per ASTM F136, ASTM F620) with a grit blast surface and HA coating (per ISO 13779-2). The stem has a 12/14 taper. The Alteon HA Femoral Stems are available in various lengths with standard and extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces. The Alteon HA Femoral Stems are compatible with the same femoral components as the predicate: - Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392) - Exactech Ziramic Zirconia Femoral Heads (K050398, K060107) - Exactech BIOLOX forte Alumina Femoral Heads (K032964, K051682) - Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters (K103012,K121392) - AcuMatch L-series Unipolar endoprostheses (K010081) - AcuMatch L-Series Bipolar Endoprostheses (K013211) . The Alteon HA Femoral Stems are compatible with the same acetabular components as the predicate: - AcuMatch A-Series Acetabular Shells and Liners (K993082, K042906) - AcuMatch A-Series Acetabular GXL Liners (K051556) - AcuMatch A-Series Acetabular Cups, All-polyethylene, Cemented (K963313) - Novation Crown Cup Acetabular Shells and Liners (K070479, K100269, K121392, K141960) - Novation Crown Cup Acetabular Shells with InteGrip (K102975) - Novation Crown Cup Constrained Liners and Rings (K071676) - Exactech Integrip Acetabular Shells (K122798) - Exactech Novation and AcuMatch E-HXL Acetabular Liners (K173583) - Exactech Alteon Acetabular Cup System (K182502)

The Vantage® Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Vantage® Total Ankle System is indicated for cemented use only.

The Vantage® Total Ankle System is a system of orthopedic implants intended for total ankle replacement. The system includes Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. This submission proposes three new components as line extensions of the Vantage Total Ankle System, which are modifications of their respective predicate components: - 3D Tibial Plates - 3D+ Tibial Plates ● - 3D/3D+ Locking Clips ● The proposed devices have the same indications for use and similar design characteristics as their predicate devices (cleared under K152217). The proposed tibial plates differ from the predicate in that they are additively manufactured, have minor geometrical modifications, and are offered in additional sizes. The proposed locking clips differ from the predicate in that they are offered in additional sizes.

The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment. - The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation. - . The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon. - . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon. - Humeral Heads are intended for use in cemented and press-fit applications. ● Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows: | P | L | F | Indications | |---|---|---|---| | √ | √ | | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems | | √ | √ | | Congenital abnormalities in the skeletally mature | | √ | | | Primary and secondary necrosis of the humeral head. | | √ | | √ | Humeral head fracture with displacement of the tuberosities | | √ | √ | Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable | | | √ | √ | Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) | | | | | √ | Displaced three-part and four-part upper humeral fractures | | | √ | | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) | | √ | √ | | Revision of failed previous reconstructions when distal anchorage is required | | √ | √ | | To restore mobility from previous procedures (e.g. previous fusion) | The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The Equinoxe Laser Cage Glenoids are intended to be used with Exactech Equinoxe Humeral Head components in Total Shoulder Arthroplasty. The Laser Cage Glenoids are composed of an Ultra High Molecular Weight Polyethylene (UHMWPE) body molded onto Ti-6Al-4V peripheral pegs and a central cage. The central cage and peripheral pegs of the implant are additively manufactured using direct metal printing (DMP) technology. The Laser Cage Glenoids are available in four sizes and four augment angle options.

The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for anatomic total shoulder arthroplasty are as follows: - · Osteoarthritis, osteonecrosis or post-traumatic degenerative problems - · Congenital abnormalities in the skeletally mature - · Primary and secondary necrosis of the humeral head - · Pathologies where arthrodesis or re sectional arthroplasty of the humeral head are not acceptable - · Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) - · To restore mobility from previous procedures (e.g. previous fusion) In the USA, the Equinoxe Stemless Shoulder is only indicated for total shoulder arthroplasty. The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use. When used in total shoulder arthroplasty, the Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Humeral Components are intended to be used with Exactech Equinoxe Stemless Humeral Heads and the Equinoxe glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V and have porous regions. The Equinoxe Stemless Humeral Components are available in in three sizes, with lengths between 17mm and 24mm.

The Exactech Alteon Modular Dual Mobility (MDM) System is a component of the Alteon Acetabular System. The Alteon MDM System is indicated for skeletally mature individuals undergoing surgery for hip replacement due to osteoarthritis, theumatoid arthritis, osteonecrosis or post-traumatic degenerative problems of the hip. The Alteon Modular Dual Mobility System is also potentially indicated for ankylosing spondylitis, congenital hip dysplasia and to restore mobility resulting from previous fusion. The Alteon MDM System is also indicated for use in primary or revision patients at a high risk of hip dislocation. The Alteon Acetabular System is intended for press-fit fixation.

The Alteon® MDM System provides modular implants for use in total hip arthroplasty (THA) to restore patient joint function. The Exactech® Alteon® Modular Dual Mobility (MDM) System is intended for use in total hip replacement as an interface between the acetabulum and femoral heads. The Alteon® MDM liners and inserts are manufactured from CoCr alloy and Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol), respectively. The Alteon® MDM liners and inserts are each available in seven configurations. The Alteon® MDM insert inner diameter (femoral head compatibility) includes 22mm or 28mm, while the Alteon® MDM liners are compatible with acetabular shells with outer diameters 46-68mm.

The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or posttraumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use. Exactech Alteon Bone Screws are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Alteon Bone Screws are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. The Exactech Alteon Bone Screws are also indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The tibial tray implant and its porous structure is manufactured from Ti-6Al-4V titanium alloy using electron beam melting (EBM) technology. This product line represents a scope extension of the Truliant knee implant system. The previously cleared Alteon Bone Screws are now cleared for use with the TRULIANT Porous Tibial Trays.

All Exactech® Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech® Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where stock is present, and to restore mobility resulting from previous fusion. Exactech® Highly Polished Femoral Stems are intended for cemented fixation.

The Exactech® Alteon® Highly Polished Femoral Stem implants are manufactured from forged Cobalt Chromium Alloy (Co-28Cr-6Mo) with a polished neck finish and polished surface finish. The Alteon® Highly Polished Femoral Stems are available in different combinations of stem length, neck offset, and diameter to accommodate an array of patient anatomies. The femoral stem has a 12/14 taper and has a trapezoidal cross-sectional stem geometry with a distal taper. Alteon® Highly Polished Femoral Stem implants are collarless femoral stems and are intended for cemented use only.

The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Exactech Equinoxe Small Reverse Shoulder is a subsystem of the Exactech Equinoxe Reverse Shoulder System which provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Small Reverse Shoulder Glenospheres and Humeral Liners. As well as minor geometry modifications, this submission proposes Equinoxe Locking Cap compatibility with the Small Reverse Glenoid Plates and Small Reverse Glenospheres.

The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use.

Truliant femoral components are for use in resurfacing femoral bone as part of tricompartmental total knee arthroplasty employing modular components from the Optetrak / Optetrak Logic and Truliant device families. Proposed Truliant porous femoral components represent modifications to Optetrak Logic porous femoral components cleared per 510(k) K140302. The proposed Truliant porous femoral components are identical to other Truliant femoral components but employ a porous structure identical to that used for the cited predicate femoral components and can be implanted as part of an uncemented surgical approach. Proposed and predicate devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in similar product size scopes, are implanted using similar surgical techniques and the same or similar instrumentation, have equivalent Indications for Use statements, and, size for size, are compatible with the same Optetrak, Optetrak Logic, and Truliant patellar and tibial components.

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. - · Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. - · Press-fit femoral stems and acetabular cups are intended for press-fit fixation. - · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Compared to predicate Alteon Monobloc Revision Stems implants, proposed Alteon Monobloc Revision Stem line extension implants offer a longer stem length option, a reduced neck offset option, and options for intermediately sized stem diameters to accommodate an array of patient anatomies.