(442 days)
When used in the Humelock II Reversible Shoulder System: 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 and structurally 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.
When used in the Humelock Reversed Shoulder System:
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 hemishoulder 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.
When used in the Humeris Shoulder System: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.q. 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 Humelock TiN Coated Glenosphere is a new component for Humelock II, Humelock Reversed, and Humeris reversed total shoulder replacement systems. The Humelock TiN Coated Glenosphere has a titanium nitride (TiN) coating, which is applied to the predicate glenosphere made of cobalt chromium molybdenum (CoCr). Compatible components for use with the Humelock TiN Coated Glenosphere to complete the reversed total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr glenospheres in the primary predicate device, K150488 and are also components in K162455 for the Humelock Reversed Shoulder System and K163669 for the Humeris Shoulder, when used for a reverse shoulder construct.
This document describes the Humelock TiN Coated Glenosphere, a new component for shoulder replacement systems. Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Acute System Toxicity Study | Completed; same as reference device |
| Cytotoxicity Study | Completed; same as reference device | |
| GC/MS Fingerprint Study | Completed; same as reference device | |
| Irritation Study | Completed; same as reference device | |
| Sensitization Study | Completed; same as reference device | |
| Bone Implantation Study | Referenced for subject device | |
| 28 Day Muscle Implantation Study | Referenced for subject device | |
| 90 Day Muscle Implantation Study | Referenced for subject device | |
| Material Characterization | Characterization of TiN coating | Demonstrates substantial equivalence to reference device coating |
| Mechanical Performance | Wear testing (worst-case loading & environment) | Completed; analysis of surface roughness, UHMWPE, and metal particles done |
| Mechanical testing for the complete system | Previously submitted with the cleared predicate device | |
| Safety and Effectiveness | Risk analysis, design controls, verification & validation activities | Demonstrate TiN coating does not increase risk or raise new questions of safety and effectiveness. |
| Substantial Equivalence (Overall) | Identical to primary predicate in indications, design, dimensions, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, compatible components, instrumentation, surgical technique. | Device is identical to primary predicate material (CoCr) with the addition of TiN coating. The coating technology is substantially equivalent to the reference device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests. The document mentions "wear testing" and "biocompatibility testing" but doesn't provide the number of devices or samples used for these non-clinical tests.
- Data Provenance: All testing mentioned is non-clinical (e.g., in-vitro, material characterization, animal studies). There is no patient data involved in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable as the evaluation relies solely on non-clinical testing and substantial equivalence to previously cleared devices and a reference device. There are no "ground truth" labels established by human experts on a clinical test set.
4. Adjudication Method for the Test Set
- This is not applicable as there is no clinical test set requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (implant component) and does not involve AI or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is established through objective scientific methods and standards for material characterization, mechanical testing, and biocompatibility, as well as the established safety and effectiveness profiles of the predicate and reference devices. For instance, biocompatibility is evaluated against ISO standards, and mechanical wear is measured.
8. The Sample Size for the Training Set
- This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as there is no training set.
§ 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.”