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510(k) Data Aggregation

    K Number
    K243509
    Device Name
    Archer PSI System
    Manufacturer
    3D-Side
    Date Cleared
    2025-05-12

    (181 days)

    Product Code
    QHE, KWS, PHX
    Regulation Number
    888.3660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Archer^R PSI System is indicated as an orthopedic instrument to assist the physician in the intraoperative positioning of total shoulder replacement components and in guiding the drill and the cut of the bone. Archer^R PSI System must only be used conjointly with Archer™ CSR Total Shoulder (K152825, K173812, K181287, K182500, K191811), Catalyst EA Convertible Stemmed Shoulder (K222317) and Archer™ R1 Reverse (K202611, K211991, K213349, K223655, K232583) components in the context of primary total shoulder replacement and following a delto-pectoral approach only. Archer^R PSI System is manufactured from a pre-operative planning validated by the surgeon in the 'Archer™ 3D Targeting' platform (K213779). Archer^R PSI System is indicated for patient population fulfilling the Archer™ CSR Total Shoulder, Catalyst EA Convertible Stemmed Shoulder and Archer™ R1 Reverse indications and for which CT images are available with identifiable placement anatomical landmarks and compliant with imaging protocol provided by Archer 3D Targeting. The device is intended for single use only. The device is intended for adult patients. The device has to be used by a physician trained in the performance of surgery.
    Device Description
    The "Archer PSI System" device is a patient-matched additively manufactured single use surgical instrument (PSI). Archer PSI System is an instrument set containing a glenoid guide and its bone model and/or a humeral guide and its bone model. This patient-specific medical device is designed to fit the patient's anatomy to transfer a patient-specific pre-operative plan to the operating room. It is intended for surgical interventions in orthopaedic procedures for total shoulder arthroplasty. The Archer PSI system instruments are designed from a draft treatment plan available via the Archer™ 3D Targeting' platform. Based on computed tomography (CT) of the shoulder anatomy, 3D CAD models of the bones and positioning and sizing of the glenoid and humeral components are submitted for evaluation to the surgeon. Upon the surgeon's approval, the guides and bone models are designed based on the validated planning and are manufactured using additive manufacturing.
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    K Number
    K241944
    Device Name
    AGILON® XO Shoulder Replacement System
    Manufacturer
    implantcast, GmbH
    Date Cleared
    2025-03-10

    (251 days)

    Product Code
    KWT, HSD, PHX
    Regulation Number
    888.3650
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: - · Non- inflammatory deqenerative joint disease including osteoarthritis and avascular necrosis, - · Post-traumatic osteoarthritis. - · Fractures, - · Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - · Multi-fragmental comminuted fractures of the humeral head, - · 3- and 4-Fragment-fractures of the proximal humerus, - · Head-splitting fractures, - · Dislocated head-splitting fractures, - · Humeral head depression with more than 40% of joint surface depressed, - · Interlocking chronic dislocation with deep HILL-SACHS lesion, - · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening), - · Posttraumatic humeral head necrosis, - · Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - · Rotator cuff tear arthropathy, - · Chronic trauma shoulder, - · Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows: - · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure - From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The device is intended for adults. The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation. The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.
    Device Description
    The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components: - Humeral Head Components ● - Glenoid and Glenosphere Components ● - Humeral Stems and Stem Extension Pieces - Metaphyseal Components ● - Fixation and Cancellous Screws ● The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.
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    K Number
    K241817
    Device Name
    InSet Total Shoulder System
    Manufacturer
    Shoulder Innovations, Inc.
    Date Cleared
    2025-02-11

    (232 days)

    Product Code
    KWT, HSD, KWS
    Regulation Number
    888.3650
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shoulder Innovation's InSet Total Shoulder System, when used with the Inset Stem, is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. Significant disability in degenerative, rheumatic disease of the glenohumeral joint; 2. Fractures of the humeral head 3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 4. Avascular necrosis of the humeral head 5. Revision where other devices or treatments have failed. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The InSet Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
    Device Description
    The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems. The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a peqged design intended for cemented fixation only.
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    K Number
    K242253
    Device Name
    JARVIS Glenoid Reverse Shoulder Prosthesis
    Manufacturer
    FH Industrie
    Date Cleared
    2024-11-25

    (117 days)

    Product Code
    PHX, KWS, KWT
    Regulation Number
    888.3660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation.
    Device Description
    The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.
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    K Number
    K240716
    Device Name
    AETOS Shoulder System Stemless Humeral Prosthesis
    Manufacturer
    Smith & Nephew, Inc.
    Date Cleared
    2024-11-20

    (250 days)

    Product Code
    PKC, HSD, KWS, KWT, PHX
    Regulation Number
    888.3660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In Anatomic: The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural dlenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis - · Non-inflammatory degenerative ioint disease - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - Revision of other devices if sufficient bone stock remains The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff. When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by: - · Non-inflammatory degenerative joint disease - · Traumatic arthritis - Revision of other devices if sufficient bone stock remains The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only. In Reverse: The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: - Rheumatoid arthritis - · Non-inflammatory degenerative joint disease - · Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - · Revision of devices if sufficient bone stock remains The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear. The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation. Note: All implant components are single use.
    Device Description
    The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.
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    K Number
    K231657
    Device Name
    AGILON® XO Shoulder Replacement System
    Manufacturer
    Implantcast, GmbH
    Date Cleared
    2024-02-16

    (254 days)

    Product Code
    KWT, HSD, PHX
    Regulation Number
    888.3650
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: - · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - · Post-traumatic osteoarthritis, - · Fractures, - · Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - · Multifragmental comminuted fractures of the humeral head, - · 3- and 4-Fragment-fractures of the proximal humerus, - · Head-splitting fractures, - · Dislocated head-splitting fractures, - · Humeral head depression with more than 40% of joint surface depressed, - · Interlocking chronic dislocation with deep HILL-SACHS lesion, - Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening), - · Posttraumatic humeral head necrosis, - · Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - · Rotator cuff tear arthropathy, - · Chronic trauma shoulder, - · Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary. In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows: - · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty - From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure - · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The device is intended for adults. The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation. The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.
    Device Description
    The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined for use in a total (anatomic and reverse) or a hemi shoulder replacement: Hemi Shoulder: - Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap) - Humeral Stems (Cementless) Total Anatomic Shoulder: - Humeral Head Components (AGILON® XO Cap) - Glenoid Components (AGILON® PE-Glenoid, Cemented) - Humeral Stems (Cementless) Total Reverse Shoulder: - Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ● - Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere) - Humeral Stems (Cementless) Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations. The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.
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    K Number
    K233712
    Device Name
    PRIMA Humeral System; PRIMA TT Glenoid
    Manufacturer
    LimaCorporate S.p.A
    Date Cleared
    2024-01-11

    (52 days)

    Product Code
    MBF, HSD, KWS, KWT, PAO, PHX
    Regulation Number
    888.3670
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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).
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    K Number
    K231099
    Device Name
    SMR Hybrid Glenoid System
    Manufacturer
    LimaCorporate S.p.A.
    Date Cleared
    2023-12-21

    (247 days)

    Product Code
    MBF, KWS, KWT, PAO, PHX
    Regulation Number
    888.3670
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K232425
    Device Name
    Signature™ ONE System
    Manufacturer
    Orthosoft Inc. (d/b/a) Zimmer CAS)
    Date Cleared
    2023-12-12

    (123 days)

    Product Code
    QHE, HSD, KWS, KWT, MBF, PHX
    Regulation Number
    888.3660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the Signature™ ONE System. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal Reverse Plus® Shoulder. Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance® Glenoid System. The Signature™ ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, and Identity™ Shoulder System. The Signature™ ONE System Guides and bone models are intended for single use only.
    Device Description
    The Signature™ ONE System is developed to assist in preoperative planning (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides and bone model) if desired in skeletally mature individuals for Total Shoulder Arthroplasty. Both anatomic and reverse (TSA and RSA respectively) approaches are supported. The Signature ONE Guides and Bone Models are designed and manufactured of polyamide (nylon) using additive manufacturing selective laser sintering (SLS), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provided nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan on the scapula. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty workflow. The Signature™ ONE System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon. The purpose of this submission is to introduce new hardware kits for the existing compatible Comprehensive Reverse Augment implants and to include the addition of pre-operative planning of humeral components. A Rotational Guide component will be available as part of these two kits. Modifications have been made to the software applications to accommodate the new guide ordering option. The overall manufacturing process, materials, sterilization methods, have not changed from the previous primary predicate and principal of operation remains similar.
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    K Number
    K230831
    Device Name
    INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
    Manufacturer
    Depuy Ireland UC
    Date Cleared
    2023-11-13

    (231 days)

    Product Code
    MBF, HSD, KWS, KWT, PAO, PKC
    Regulation Number
    888.3670
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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
    Device Description
    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).
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