(141 days)
In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
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 humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.
The Humeris Shoulder is a system of shoulder components that can be used in either an anatomic or a reverse configuration.
The Humeris Cementless Humeral Stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 8-16mm and a length of 100mm. The distal end of the humeral stem is trapezoidal with a polished surface. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP Ti) and hydroxyapatite (HA) coating.
The Humeris Cemented Humeral Stem is also manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-14mm and a length of 100mm. The distal end of the humeral stem is trapezoidal with a polished surface.
Both humeral stems incorporate a female taper for attachment of compatible components. The Humeris humeral stems can be used with a straight or angled double taper connector or a centered spacer, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomical shoulder configuration.
The straight and angled double taper connectors and the centered spacers have a male taper on each end and are used to connect the humeral stem to the humeral head. The straight double taper connector and three options of angled double taper connectors allow the angle of the head to be changed from 135° to 132° or 138° and the offset of the humeral head to be increased from +0 to +3 or +5 mm. The centered spacers also allow the offset of the humeral head to be increased from +0 to +3 or +5 mm. All of the double taper connectors and centered spacers are compatible with all sizes of humeral stems and humeral heads. The double taper connectors and the centered spacers are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.
The humeral heads are available in diameters of 39 – 54 mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem. The humeral heads are manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12.
The 2 peg cemented glenoid component is available in sizes extra small, small, medium and large and features two pegs for cemented fixation to the glenoid bone. It is manufactured from ultra-high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.
The 3 or 4 peg cemented glenoid component is also available in sizes extra small, small, medium and large. Sizes extra small and small have three fixation pegs. Sizes medium and large have four fixation pegs. The 3 or 4 peg cemented glenoid component is manufactured from ultra-high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. The central peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.
The Humeris humeral stems can also be used with a humeral cup and 135/145 adapter or a 135/145 humeral cup, a centered or eccentric glenosphere with or without a central screw, a glenoid baseplate, post extensions and standard (compression) or locking bone screws for use in a reverse shoulder configuration.
The humeral cup and the 135/145 humeral cup are available in two sizes, Ø36 and Ø40 mm. Each size is available in two versions, standard and mobility. Each version is available in three heights: +3mm, +6mm, +9mm; and is compatible with all sizes of humeral stems. A 24mm male taper allows attachment of the 135/145 cup to the humeral stem. If the humeral cup is used, it must be used with a 135/145 adaptor. Male tapers allow attachment of the humeral cup to the 135/145 adaptor and of the 135/145 adaptor to the humeral stem. The humeral cup and 135/145 humeral cup are preassembled, one-piece components manufactured from UHMWPE conforming to ISO 5834-2 and Ti-6Al-4V alloy conforming to ISO 5832-3.
The glenosphere is also available in Ø36 and Ø40 mm sizes and in centered and eccentric styles. The eccentric glenospheres are designed to be offset from the center of the glenoid baseplate. All glenospheres have a 10° tilt, meaning that the curvature of the glenosphere extends 10° beyond the equator of a hemisphere. This additional articular surface lateralizes the center of rotation to help reduce the potential for scapular notching by the humeral cup. All glenospheres mate with the glenoid baseplate via a taper lock. The glenospheres are also available with an optional central, cannulated screw. This screw can be threaded through the central post of the baseplate for additional security. The glenosphere components are manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12. The glenosphere screw is manufactured from Ti-6Al-4V allov conforming to ISO 5832-3.
The glenoid baseplate has a round base with a central, cannulated post and four peripheral, threaded screw holes. The outer edges of the baseplate are tapered to lock with the glenosphere component.
The glenoid baseplate is used with 4.5mm standard or locking bone screws for added stability. The bone screws are available in lengths from 20 - 50mm in 5mm increments. Each screw allows an angulation of +/- 12° around the axial axis of the screw hole.
Optional post extensions are available to extend the central post of the baseplate and provide additional anchoring in cases with poor bone quality. The post extensions are available in 6mm and 10mm lengths. When used, the post extensions screw into the baseplate post.
The glenoid baseplate, standard and locking screws, and post extensions are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxyapatite coating.
I am sorry, but the provided text does not contain information about acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device. The document is a 510(k) premarket notification for a shoulder joint prosthesis (Humeris Shoulder) and details its indications for use, device description, materials, and non-clinical testing. It explicitly states under "Clinical Testing" that "Clinical testing was not necessary to determine substantial equivalence of the Humeris Shoulder to the predicate devices." Therefore, I cannot generate the requested table and study information.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”