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510(k) Data Aggregation

    K Number
    K241878
    Device Name
    Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
    Manufacturer
    Stryker Corporation (Tornier, Inc.)
    Date Cleared
    2024-12-06

    (161 days)

    Product Code
    KWS, HSD, PHX
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Corporation (Tornier, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tornier Humeral Reconstruction System (Tornier HRS) IN ANATOMIC: The Tornier HRS 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 Tomier HRS is indicated for use as a replacement of shoulder joints disabled by: - · Rheumatoid arthritis with pain - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Revision of other devices if sufficient bone stock remains IN REVERSE: The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by: - · Rheumatoid arthritis - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Massive and non-repairable rotator cuff tear - · Revision of other devices if sufficient bone stock remains The reversed tray and polyethyiene inset are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle. Notes: - · All components are single use. - · The coated humeral stem is intended for cemented or cementless use. - · The all-poly glenoid components are intended for cemented use only - · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. - · Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. - The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy. Tornier Perform Humeral System - Stem (Tornier PHS-Stem) In Anatomic: The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement. The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by: · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis - · Proximal humeral malunions - · Post-traumatic arthritis - · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is recommended for patients with a suspected material sensitivity to cobalt alloy. All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with cemented components, in a total shoulder arthroplasty. In Reverse: The PERFORM™ Humeral System – Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following: · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis - · Pseudoparalysis or anterior superior escape - · Rotator cuff tear arthropathy - · Proximal humeral malunions - · Post-traumatic arthritis · Revisions or fractures of the humere adequate fixation can be achieved and adequate bone stock remains The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle. All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
    Device Description
    Tornier HRS (formerly branded Aequalis Flex Revive Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. The Tornier Humeral Reconstruction System (Tornier HRS) is a line existing Aequalis™ Flex Revive™ Shoulder System (AFR) (K191318, cleared June 14, 2019) that builds upon the AFR system with additional sized distal stems, proximal bodies, and reversed insert trays, new monoblock stems, humeral head couplers and MR Conditional labeling for Tornier HRS line extension components. The Tornier Perform Humeral System (Tornier PHS-Stem) (K2013 15) is also being expanded to include additional sized Vitamin E UHMWPE reversed inserts and a renaming of these inserts for clarity.
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    K Number
    K241609
    Device Name
    Tornier Humeral Reconstruction System (Tornier HRS)
    Manufacturer
    Stryker Corporation (Tornier, Inc.)
    Date Cleared
    2024-09-10

    (97 days)

    Product Code
    KWS, HSD, PHX
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Corporation (Tornier, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IN ANATOMIC: The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Tornier HRS Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Tornier HRS Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis with pain - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - Revision of other devices if sufficient bone stock remains IN REVERSE: The Tornier HRS Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by: - Rheumatoid arthritis - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - Massive and non-repairable rotator cuff tear - Revision of the devices if sufficient bone stock remains The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle. Notes: - All components are single use. - The coated humeral stem is intended for cemented or cementless use. - The all-poly glenoid components are intended for cemented use only. - The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. - Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
    Device Description
    Tornier HRS (formerly branded Aequalis™ Flex Revive™ Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant system intended for total or partial replacement of the glenohumeral articulation. Tornier HRS includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and poly inserts. Tornier HRS is implanted by a surgeon and is designed to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and inserts. In addition, Tornier HRS can be transformed from anatomic to reverse shoulder prosthesis without the humeral implant assembly during revision surgery. The humeral length is measured to determine the overall humeral implant construct length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity. The proximal body, stem, and spacers are made from Ti6A4V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.
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    K Number
    K230352
    Device Name
    Tornier Humeral Nail and Tornier Long Humeral Nail
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2023-10-31

    (264 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tornier Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
    Device Description
    The Tornier Humeral Nail and Tornier Long Humeral Nail include intramedullary nails and screws. The Tornier Humeral Nail is a straight, cannulated intramedullary nail available in 9mm proximal diameter with a tapered 7mm distal diameter with nail lengths of 210mm, 230mm, 250mm, and 270mm long and a tapered 8mm distal diameter with nail lengths of 130mm, 210mm. 230mm. 250mm, and 270mm long. Both distal diameter sizes are available in right and left configurations. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the 130mm nails incorporate two or three screw holes for distal stabilization using 4.3mm screws. The nails and screws are manufactured from anodized titanium alloy. The polyethylene insert is manufactured from ultrahigh molecular weight polyethylene (UHMWPE).
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    K Number
    K220914
    Device Name
    Tornier Perform Humeral System – Fracture
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2022-10-14

    (198 days)

    Product Code
    PHX, HSD, KWS, KWT, PAO
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In Anatomic: The Tornier Perform Humeral System - Fracture combined with a humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement. The Tornier Perform Humeral System - Fracture is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The Tornier Perform Humeral System - Fracture is indicated for use as a replacement of shoulder joints disabled by: • Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral head fracture and displaced 3-or 4-part proximal humeral fractures · Fracture sequelae - Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy. All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. In a total shoulder arthroplasty, the Tornier Perform Humeral System - Fracture is intended to be used with cemented polyethylene glenoid components. In Reverse: The Tornier Perform Humeral System - Fracture combined with a reverse insert is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by: • Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures • Proximal humerus bone defect · Fracture sequelae • Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed fracture stem for patients with a functional deltoid muscle. All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. The Tornier Perform Humeral System – Fracture is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
    Device Description
    The Tornier Perform Humeral System – Fracture is a convertible humeral fracture system for anatomic, reverse, and hemiarthroplasty of the shoulder. The system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The Tornier Perform Humeral System - Fracture is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty. The Tornier Perform Humeral System – Fracture includes titanium fracture stems, titanium couplers, titanium spacers and titanium screws. The system is compatible with commercially available Perform humeral heads and reversed inserts. The system also includes reusable instruments used to implant the shoulder prosthesis.
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    K Number
    K220418
    Device Name
    Tornier Perform Humeral System – Stemless
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2022-09-14

    (212 days)

    Product Code
    PKC
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement. The Tornier Perform® Humeral System - Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System -Stemless is indicated for use as a replacement of shoulder joints disabled by: - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis - · Post-traumatic arthritis Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy. All components are single use and intended for cementless use. The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.
    Device Description
    The Tornier Perform Humeral System - Stemless is metaphyseal humeral system intended for anatomic total shoulder arthroplasty. The Perform Humeral System - Stemless is implanted with existing Tornier anatomic glenoid systems. The Tornier Perform Humeral System – Stemless includes new titanium nucleus components and previously-cleared modular humeral heads (K201315). The system also includes reusable instruments used to implant the shoulder prosthesis.
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    K Number
    K211359
    Device Name
    Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2021-11-12

    (193 days)

    Product Code
    PHX, KWS, QHE
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator with pain disabled by: Rheumatoid arthritis, Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), Correction of functional deformity, Fractures of the humeral head, Traumatic arthritis, Revision of glenohumeral joint if sufficient native glenoid bone remains. All components are single use. The Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant. BLUEPRINT™ Patient Specific Instrumentation: BLUEPRINT ™ Glenoid Guides: The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgerv. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose. Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if Patient-Specific instruments or Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.
    Device Description
    Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant (Patient-Matched Glenoid) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis. The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis. BLUEPRINT™ Patient Specific Instrumentation: BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier is the legal manufacturer for the hardware and the software. BLUEPRINT ™ Glenoid Guides: The BLUEPRINT ™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software. BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Generate information required to design a patient-specific glenoid component when appropriate.
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    K Number
    K213124
    Device Name
    Tomier Perform™ Reversed Glenoid Cannulated Glenospheres
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2021-10-26

    (29 days)

    Product Code
    PHX, KWS
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tornier Perform Reversed Glenospheres are 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 (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Revision of the devices if sufficient bone stock remains Notes: - · All components are single use. - The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
    Device Description
    The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres are part of a reverse shoulder prosthesis consisting of cannulated cobalt chromium and titanium alloy glenospheres. The Tornier Perform Reversed Glenoid Cannulated Glenospheres are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status. The Tornier Perform Reversed Glenoid Cannulated Glenospheres must be used in association with a compatible Tornier reversed glenoid and humeral component. The cannulated glenosphere can be used as part of the glenoid implant. The glenoid implant is composed of a baseplate with central and peripheral anchoring screws and a glenosphere. An optional press-fit post is available that can be used in lieu of the central anchoring screw. Ancillary instruments are also provided for the implantation of the prosthesis.
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    K Number
    K201315
    Device Name
    PERFORM Humeral System – Stem
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2020-09-11

    (116 days)

    Product Code
    PAO, HSD, KWS, KWT, PHX
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In Anatomic: The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement. The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The PERFORM Humeral System – Stem is indicated for use as a replacement of shoulder joints disabled by: - Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis . - Correction of functional deformity - Post-traumatic arthritis 0 - o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy. All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty. In Reverse: The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following: - o Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis - Pseudoparalysis or anterior superior escape ● - Rotator cuff tear arthropathy - Correction of functional deformity - Post-traumatic arthritis - o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle. All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
    Device Description
    The PERFORM Humeral System - Stem is an inlay convertible humeral system intended for anatomic, reverse, and hemiarthroplasty of the shoulder system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The PERFORM Humeral System - Stem is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty. The PERFORM Humeral System – Stem includes titanium humeral stems, cobalt chrome and titanium humeral heads, titanium humeral head couplers, conventional and Vitamin E UHMWPE reversed inserts, and titanium humeral spacers. The system also includes reusable instruments used to implant the shoulder prosthesis.
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    K Number
    K191318
    Device Name
    AEQUALIS FLEX REVIVE Shoulder System
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2019-06-14

    (30 days)

    Product Code
    KWS, HSD, PHX
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IN ANATOMIC: The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The AEQUALIS™ FLEX REVIVE™ Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis with pain - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Revision of other devices if sufficient bone stock remains IN REVERSE: The AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by: - Rheumatoid arthritis - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Massive and non-repairable rotator cuff tear - · Revision of the devices if sufficient bone stock remains The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision with a functional deltoid muscle.
    Device Description
    AEQUALIS™ FLEX REVIVE™ Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts. The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery. The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity. The proximal body, stem, and spacers are made from Ti6A14V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.
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    K Number
    K183696
    Device Name
    Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2019-01-30

    (30 days)

    Product Code
    PHX, KWS
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and non-repairable rotator cuff-tear with pain disabled by: - · Rheumatoid arthritis - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - Revision of the devices if sufficient bone stock remains
    Device Description
    The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is a modular system consisting of a Glenoid Component Assembly and a Humeral Component Assembly for total shoulder arthroplasty. The associated shoulder surgical instruments are intended to facilitate proper implantation of this shoulder system. The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is designed and indicated for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
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