(55 days)
The Humelock II Reversible Shoulder is indicated for primary, fracture 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 aud structuraly suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stems are intended for cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.
The Humelock Reversed Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable cuff tear.
The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.
The humeral stem of the Humelock Reversed Cemented Shoulder Prothesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prothesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotational spoiler can be used with either the cementless or the cemented stems.
The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
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A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
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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 32mm Glenosphere and Humeral Cup are new components for Humelock II Reversible Shoulder System, Humelock Reversed, and Humeris Shoulder, when used for a reverse shoulder construct. Compatible components for use with the 32mm Glenosphere and Humeral Cup are the same as those previously cleared compatible components for use with the 36mm and 40mm glenospheres in the primary predicate device, K150488 Humelock II Reversible Shoulder System, K162455 Humelock Reversed Shoulder System, and K163669 Humeris Shoulder System, when used for a reverse shoulder construct.
This is a 510(k) premarket notification for a medical device, which seeks to establish substantial equivalence to a predicate device rather than demonstrate a specific level of performance against acceptance criteria in a clinical study. The document states that clinical testing was not necessary for this particular submission.
Therefore, the requested information regarding acceptance criteria and performance data from a study demonstrating the device meets those criteria, sample sizes, expert qualifications, etc., is not available in this document.
The document primarily focuses on demonstrating that the 32mm Glenosphere and Humeral Cup are substantially equivalent to previously cleared 36mm and 40mm glenospheres and humeral cups. The basis for this substantial equivalence is described as:
- Same design and materials: The 32mm Glenosphere and Humeral Cup are of the same design and materials as the previously cleared 36mm and 40mm glenospheres and humeral cups.
- Previously submitted mechanical testing: Mechanical testing for the complete system was previously submitted with the cleared predicate device.
- Engineering analysis and range of motion analysis: These were also completed.
In essence, the "study" demonstrating the device meets "acceptance criteria" here is the engineering analysis and mechanical testing for the complete system previously submitted with the predicate device, combined with the argument that the 32mm components are a smaller size within an already cleared product range and do not raise new safety or effectiveness concerns.
§ 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.”