(90 days)
The Select Shoulder Offset Humeral Heads, when used with one of the Select Shoulder Humeral Stems and Glenoid Components (if applicable), are intended for use in treatment of the following:
- Patient conditions, including but not limited to, noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the humeral neck, arthrodesis or hemiarthroplasty.
- Cuff tear arthropathy.
- Avascular necrosis or osteonecrosis of the humeral head.
- Tumor resection.
The Select Shoulder Offset Humeral Heads are metallic components manufactured from cobalt chrome alloy (CoCrMo). The heads, once impacted onto one of the Select Shoulder humeral stems, are designed to articulate with the normal human glenoid or with a replacement all-poly glenoid component. The humeral heads feature a female taper which allows for attachment to the male taper of the Sulzer Orthopedics Select Shoulder Humeral Stems. The articulating surface of the head is polished. The underside of the head, with the exception of the taper attachment feature, may be either polished or grit blasted. Similar to the face of a clock, the underside of the head is numbered from 1-12, giving the surgeon the ability to reference and select the position of the head relative to the glenoid. The location of the female taper is offset from center, thus permitting ease of insertion into the joint, allowing closer replication of the normal head anatomy permitting accurate anatomic soft tissue balancing, and providing greater contact with the glenoid when the humerus is in a normal resting position. The heads are available in a variety of heights and diameters. The humeral heads are designed for use with Sulzer Orthopedics Humeral Stems and/or glenoid components which come in a variety of sizes for increased stability of the glenohumeral joint.
The Sulzer Orthopedics Inc. Select® Shoulder Offset Humeral Heads are metallic components manufactured from cobalt chrome alloy (CoCrMo). These heads are designed to articulate with the normal human glenoid or with a replacement all-poly glenoid component after being impacted onto one of the Select Shoulder humeral stems.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pulloff Strength | Comparable to currently marketed devices. |
| Contact Area | Adequate contact area at various levels of abduction. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the pulloff strength or contact area testing.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It states "Testing indicated," implying internal testing conducted by Sulzer Orthopedics Inc.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The "ground truth" in this context refers to performance testing against established engineering standards or predicate device performance, not expert medical opinion on clinical outcomes based on patient data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The testing appears to be objective, laboratory-based engineering evaluation rather than data requiring human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a physical orthopedic implant, not a diagnostic imaging or AI-assisted system that would involve human readers interpreting output.
6. Standalone Performance Study
Yes, the studies on "pulloff strengths" and "contact area" represent standalone performance evaluations of the device's physical and mechanical properties. These tests assess the device's inherent characteristics without human intervention during the measurement process.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance criteria appears to be based on:
- Engineering Standards / Predicate Device Performance: The device's pulloff strength was compared to "currently marketed devices," implying that the performance of existing, accepted devices served as the benchmark.
- Biomechanical Adequacy: "Adequate contact area" suggests a biomechanical requirement for proper joint function.
8. Sample Size for the Training Set
This information is not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
§ 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.”