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The Exactech® TRULIANT® Knee System is 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. It is 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. The TRULIANT Porous Tibial Trays are indicated for cemented or cementless use.

The Exactech® Truliant® Knee System is a total knee replacement system comprised of femoral, tibial, and patellar implants. The proposed Porous Tibias are additional tibial tray implant variants intended for use with the Truliant Knee System. This submission proposes Truliant Porous Tibial Trays made from titanium alloy consolidated via direct metal laser sintering (DMLS). This submission additionally proposes a Porous Tibial Tray variant without screw holes, additional intermediate tray sizes, and minor geometric change(s) to the predicate Porous Tibial Tray design.

The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment. - The cemented primary humeral stem, longrevision 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 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: - 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 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 in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), 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 proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The Central Screw Baseplate System is comprised of devices that will be included as part of the Exactech Equinoxe® Shoulder System for reverse total shoulder arthroplasty (rTSA). The Central Screw Baseplate System includes Glenoid Baseplates, Central Compression Screws, a Locking Plate, a Locking Nut, and a Glenosphere Locking Screw. Previously cleared components used with the Central Screw Baseplate System include Peripheral Screws and Glenoid components. The design of the proposed Central Screw Baseplate System is based on the existing foundation and principles of the currently marketed Equinoxe Standard and Small Reverse Baseplates.

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 fixed-bearing total ankle replacement device that is comprised of four components (Tibial Plate, Liner, Talar Component and Locking Component). The predicate Vantage Fixed Bearing Liners are constructed of compression-molded UHMWPE. This submission proposes Vantage Fixed Bearing Liners made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Fixed Bearing Liners as well as additional Fixed Bearing Liner thickness options.

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.

Vantage Total Ankle Flat Cut Talar Components are for use in resurfacing talar bone as one of the four components of the Exactech Vantage Total Ankle System (including tibial plate, tibial insert, locking component and talar component) intended for use in total ankle arthroplasty. The proposed Vantage Flat Cut Talar Components represent modifications to the Vantage Total Ankle Talar Components cleared per 510(k) K152217. The proposed Vantage Total Ankle Flat Cut Talar Components are equivalent to the previously cleared talar components, but utilize one additional fixation structure and flat cut geometry on devices' bone-contacting surface rather than a curved underlying surface featured in the cleared, predicate talar components. The proposed and predicate devices share the same fundamental scientific technology, have the same intended use, indications for use, and similar design features, employ the same materials of construction and manufacturing processes, are offered in the same product size scope, are implanted using similar surgical techniques and instrumentation, work with the same compatible Vantage Total ankle tibial plates and locking components, and, size for size, are compatible with the same tibial inserts from the previously cleared Exactech Vantage Total Ankle System.

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 System is a reverse shoulder system that 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 Reverse Shoulder System; these geometry modifications are the entire basis for the proposed Exactech Equinoxe Small Reverse Shoulder System.

The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total 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 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) - To restore mobility from previous procedures (e.g. previous fusion) The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use. The Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V, and have porous regions. The Equinoxe Stemless Humeral Heads are manufactured from Cobalt Chrome. The Equinoxe Stemless Humeral Components are available in two types, Caged and Non-Caged, with each type available in three sizes, with lengths between 17mm and 24mm. The Equinoxe Stemless Humeral Heads are available in 12 sizes, with diameters between 38mm and 53mm and two height options (Extra Short, Short).

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 Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V with a polished neck region, grit blast surface and HA coating on the stem body. The stem has a 12/14 taper. The Alteon HA Femoral Stems 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 intended for press-fit applications and are not intended for use with bone cement.

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 proposed Exactech Equinoxe Reverse Shoulder Compression Screws. Glenosphere Locking Screw, and Locking Cap devices represent a modification of the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap (K063569 and K110708) used in reverse shoulder arthroplasty. All devices were cleared via 510(k) K063569 except the 50mm and 54mm Equinoxe Reverse Shoulder Compression Screws. These sizes were cleared via 510(k) K110708. The only difference between the proposed Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap and predicate Equinoxe Compression Screws, Glenosphere Locking Screw, and Locking Cap is the sterilization method. The predicate compression screws, glenosphere locking screw, and locking cap are provided sterile via gamma radiation. The modified compression screws, glenosphere locking screw, and locking cap will be supplied non-sterile and must be sterilized by steam sterilization in a separately provided re-usable sterilization container prior to implantation. Cleaning and sterilization instructions are provided in the package insert for the Equinoxe Reverse Shoulder System Screw Components.

The Equinoxe Humeral Reconstruction Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Revision where other devices or treatments have failed - Correction of functional deformity - Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment - Traumatic arthritis - Oncology applications including bone loss due to tumor resection. - Significant humeral resection which are unmanageable using other treatment methods The Equinoxe Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures. The Equinoxe Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present. In the USA, the Equinoxe Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications. The Equinoxe Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.

The proposed Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies represent a modification of the predicate Exactech Equinoxe Humeral Reconstruction Prosthesis Proximal Bodies cleared in K143659. Both the predicate and proposed devices have the same intended use, general design features and basic fundamental scientific technology. The only difference between the predicate and the proposed device is a decreased tuberosity thickness.

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 Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.

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. Truliant femoral components represent modifications to Exactech One Logic femoral components cleared per 510(k) K153776. The proposed Truliant femoral components are identical to predicated One Logic femoral components, with the following key exceptions: - . Tapered anterior chamfer and patella flange to reduce the appearance of implant / bone overhang - . Patella flange cement pocket has been modified to increase cement / bone contact area Additional modifications have been made to facilitate manufacturing. Like other femoral implants in compatible device families, One Logic femoral components are made from CoCr alloy and are designed to articulate on an ultra-high molecular weight polyethylene tibial insert seated in a metal tibial tray. Truliant femoral components have the same basic features and articulating surface finish as predicate One Logic femoral components while providing surgeons with an option for a femoral implant with a patella flange that has been comparatively streamlined in the medial-lateral aspects. The articulating congruence featured in all Optetrak and Optetrak Logic femoral-tibial condyle contact is maintained for Truliant femoral components. Cruciate-retaining Truliant femoral components also feature the same patella entry / exit point at the distal trochlear groove featured on predicate One Logic femoral components and intended to enhance patella transition. The proposed devices operate using same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.