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Hemiarthoplasty/Conventional Total Application: · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - · Correction of functional deformity. · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. • Difficult clinical management problems, including cuff arthropathy, where other may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Reverse Application: Zimmer Biomet Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation). The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System cleared previously in K213856 is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty. The Identity Shoulder System in the anatomic configuration is comprised of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head. This configuration can be used as a hemi-athroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component. The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing, This construct is intended to be used with a compatible glenosphere/baseplate component. The current 510(k) is for additional sizes/styles of humeral trays and bearings for the reverse configuration. Extra Extended trays in 3 heights in a neutral configuration are being additional lateralization. A uniforn thickness bearing is also being added in an effort to improve internal/external range of motion and reduce potential of scapular notching.

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.

Anatomic Total Shoulder or Hemi-Shoulder The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: - Osteoarthritis - Post-traumatic arthrosis - Focal avascular necrosis of the humeral head - Previous surgeries of the shoulder that do not compromise the fixation The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - Revision where other devices or treatments have failed. - Correction of functional deformity. - Fractures of the humeral head (with Short Humeral Stems). - Fractures of the humeral head and proximal humerus, where other methods of treatments are deemed inadequate (with Standard or Long Stems). - Difficult clinical management problems where other methods of treatment may not be inadequate. Reverse Total Shoulder The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem. - A severely painful, disabling, arthritic joint - Fractures of the humeral head (with Short Humeral Stems) - Fractures of the humeral head and proximal humerus (with Standard or Long Stems) - Revisions of previously failed shoulder joint replacements

The INHANCE™ Convertible Glenoid system consists of a Baseplate with minor modifications compared to the previously cleared Baseplate in K212737 and a poly insert that locks atop the Baseplate to allow for an anatomic procedure. The Convertible Glenoid Insert implants are offered in four sizes: Small (24.0mm), Medium (26.5mm), Large (29.0mm), and X-Large (31.5mm). The Convertible Glenoid Insert implants consist of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) articulation surface and an interrupted fixation ring along with a finned central fixation post to facilitate poly locking to the Convertible Glenoid Baseplate. The INHANCETM Convertible Glenoid Insert Implants have a lateral surface that is concave and designed to articulate with the Humeral Heads from the INHANCE Anatomic Stemmed and Stemless Shoulder Systems that are indicated for use in total shoulder arthroplasty. The INHANCE™ Convertible Glenoid Baseplates, previously cleared in K212737, were modified to provide for a means of mechanical fixation between the Convertible Glenoid Inserts and Baseplates. The INHANCE Convertible Glenoid implants are compatible with the implants and instruments previously cleared for use in the INHANCE Anatomic Shoulder System (K202716), the INHANCE Stemless Anatomic Shoulder System (K203108), and the INHANCE Reverse Shoulder System (K212737).

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.

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.

Hemiarthoplasty/Conventional Total Application: - · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - · Rheumatoid arthritis. - · Correction of functional deformity. - · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Reverse Application: Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation). The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty. The Identity Shoulder System in the anatomic configuration is comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component. The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing. This constructed is intended to be used with a compatible glenospheres/baseplate component.

Anatomic Total Shoulder or Hemi-Shoulder The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: - Osteoarthritis - Post-traumatic arthrosis - Focal avascular necrosis of the humeral head - Previous surgeries of the shoulder that do not compromise the fixation The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - Revision where other devices or treatments have failed. - Correction of functional deformity. - Fractures of the humeral head (with Short Humeral Stems) - Fractures of the proximal humerus (with Standard or Long Stems) - Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate. Fixation Methods The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

The INHANCE™ Hybrid Anatomic Glenoid Implants are offered in five sizes: X-Small (21.5mm), Small (24.0mm), Medium (26.5mm), Large (29.0mm), and X-Large (31.5mm). The Glenoid Implants consist of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) articulation surface and fixation ring along with an additively manufactured Ti-6Al-4V (titanium alloy) central fixation post. The INHANCE™ Hybrid Anatomic Glenoid Implants have a lateral surface that is concave and designed to articulate with the Humeral Heads from the Ignite Anatomic Stemmed and Stemless Shoulder Systems that are indicated for use in total shoulder arthroplasty.