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The Exactech® Equinoxe® Scapula Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the scapula. Specific clinical indications for ORIF are as follows: Levy Type I, IIA, and IIB fractures, fracture dislocations, osteotomies, and non-unions of the acromion and scapular spine. The 3.5mm diameter and 2.7mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula. The Straight Plates of the EPIC Fracture Plate System (cleared under K172441) are also intended for use with the Exactech® Equinoxe® Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.

The Exactech® Equinoxe® Scapula Fracture System with EPIC Screws and Straight Plates is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the acromion and scapular spine. The Exactech® Equinoxe® Scapula Fracture System includes a range of sizes and options of scapula fracture plates and screws to accommodate varying patient anatomy and needs. Previously cleared components to be used with the Exactech® Equinoxe® Scapula Fracture System include the Exactech® EPIC Locking Screws, EPIC Non-Locking Screws, and EPIC Straight Plates. All components work together in various configurations to address scapular ORIF procedures.

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 Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus. The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.

The Exactech® Equinoxe® PHx® Fracture System is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the proximal humerus. The Exacteche Equinoxe® PHx® Fracture System includes various sizes of fracture plates and fixation screws and is to be used with the 3.5mm diameter Exactech® EPIC locking and non-locking style screws (cleared under K153340). The Exactech® Equinoxe® PHx® Fracture System with the Exactech® EPIC Screws are intended to be used for internal fixation of fractures, fracture dislocations, non-unions, and osteotomies of the proximal humerus. The Exactech® EPIC Screws were previously cleared with the Epic Extremity Plate System with an indication for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. This is an indication change only for the 3.5mm EPIC locking and non-locking screws.

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: | 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 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 proposed Exactech Equinoxe Reverse Humeral Liners and Humeral Adapter Trays are intended for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.

The TRULIANT E-PX Tibial Inserts and Patellas 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 E-PX Patellas are intended for cemented use only.

The TRULIANT Knee System is a system of orthopedic implants intended for total knee replacement. The system includes Femoral components, Tibial Trays, Tibial Inserts, and Patellas. The Tibial Inserts and Patellas used in the TRULIANT Knee system currently are constructed of compression molded UHMWPE and extruded UHMWPE respectively. This submission proposes TRULIANT Tibial Inserts and Patellas made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Tibial Insert devices as well as additional intermediate TRULIANT CC Tibial Insert size options.

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 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 Exactech Alteon Short Tapered Wedge is a collarless, press-fit femoral stem component to be used in total or hemi hip arthroplasty, and is designed to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal. The Alteon Short Tapered Wedge has seventeen size offerings and two lateral offsets per size. It is made from titanium alloy and includes a 12/14 trunnion, a polished neck region, a commercially pure titanium plasma spray coated press-fit region, and a bead-blasted (satin) distal surface finish. The 12/14 trumion allows for compatible connection with Exactech femoral heads. As a line extension to the predicate, the proposed Alteon Short Tapered Wedge differs from the predicate in that it features a shortened distal stem length.

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 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 Reverse Shoulder Glenospheres and Extended Locking Cap are for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Glenospheres and Locking Cap; these geometry modifications are the entire basis for the proposed devices.