(14 days)
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Not Found
No
The device description and intended use focus on the mechanical design and materials of a shoulder implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an orthopedic implant (glenoid component in a total shoulder arthroplasty) intended to treat various joint conditions, including degenerative and inflammatory diseases, fractures, and failed previous surgeries, which are therapeutic indications.
No
Explanation: The provided text describes a medical implant (glenoid component for total shoulder arthroplasty) intended for treatment, not for diagnosing conditions.
No
The device description clearly describes a physical implant made of polyethylene and titanium, intended for surgical implantation in the shoulder joint. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "Curved-back Pegged All-Poly Glenoid," which is a component of a total shoulder arthroplasty system. It is an implant designed to be surgically placed within the body to replace the natural glenoid.
- Intended Use: The intended use describes the conditions for which the device is used in total shoulder arthroplasty, which is a surgical procedure.
- No Mention of Samples or Testing: There is no mention of the device being used to test samples from the body or to provide diagnostic information based on such tests.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Select Shoulder Curved-back Pegged All-Poly Glenoids, when used with one of the Select Shoulder Humeral Stems and Humeral Heads, are intended only for use with bone cement in cases of total shoulder arthroplasty for treatment of the following:
- Patient conditions, including but not limited to, noninflammatory degenerative joint > 1. 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-2. 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 3. persists.
- Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the 4. humeral neck, arthrodesis or hemiarthroplasty.
-
- Cuff tear arthropathy.
- Avascular necrosis or osteonecrosis of the humeral head. 6.
- Tumor resection. 7.
Product codes
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Device Description
The Curved-back Pegged All-Poly Glenoid is a one piece, polyethylene (ASTM F648) design intended to reproduce the function of the natural glenoid. The design is such that the component may be used in either the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.
This design features a curved articulating surface. The component has two grooved pegs bounded by two dovetail cement grooves which provide translational and rotational stability to the implant as well as to enhance cement fixation. The grooves in the pegs also allow the surgeon to intraoperatively trim the length in the glenoid vault is shallow and prevents the full length from being seated. Titanium (ASTM F136) x-ray marker pins are incorporated in the superior aspects of the component to assist in postoperative evaluation. The lateral surface of the glenoid component accommodates the humeral head. The articulating geometry is nonconstrained for greater range of motion and greater translation.
Contact area testing indicates that the Curved-back Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The designs are substantially equivalent to the Select Shoulder Pegged All-Poly Glenoids and Keeled All-Poly Glenoids as well as those glenoids used in the Orthornet/3M Modular Neer II Shoulder System, the Zimmer Fenlin Total Shoulder, the Smith & Nephew Richards Cofield Shoulder, the Kirschner/Biomet Modular Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuv Global Total Shoulder System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
K970567
510(k) SUMMARY
February 13, 1997
FEB 27 1997
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Sulzer Orthopedics Inc. Select Shoulder Curved-back Pegged All-Poly Glenoids.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, TX 78717
(512) 432-9900 |
|----------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Regulatory Affairs Manager |
| Classification Name: | 21 CFR Part 888.3650 - Shoulder joint metal/polymer non-
constrained cemented prosthesis |
| Common/Usual Name: | Glenoid prosthesis |
| Trade/Proprietary: | Select Shoulder Curved Back Pegged All-Poly Glenoids |
Product Description/Substantial Equivalence:
The Curved-back Pegged All-Poly Glenoid is a one piece, polyethylene (ASTM F648) design intended to reproduce the function of the natural glenoid. The design is such that the component may be used in either the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.
This design features a curved articulating surface. The component has two grooved pegs bounded by two dovetail cement grooves which provide translational and rotational stability to the implant as well as to enhance cement fixation. The grooves in the pegs also allow the surgeon to intraoperatively trim the length in the glenoid vault is shallow and prevents the full length from being seated. Titanium (ASTM F136) x-ray marker pins are incorporated in the superior aspects of the component to assist in postoperative evaluation. The lateral surface of the glenoid component accommodates the humeral head. The articulating geometry is nonconstrained for greater range of motion and greater translation.
Contact area testing indicates that the Curved-back Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction.
The designs are substantially equivalent to the Select Shoulder Pegged All-Poly Glenoids and Keeled All-Poly Glenoids as well as those glenoids used in the Orthornet/3M Modular Neer II Shoulder System, the Zimmer Fenlin Total Shoulder, the Smith & Nephew Richards Cofield
1
Shoulder, the Kirschner/Biomet Modular Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuv Global Total Shoulder System.
The Select Shoulder Curved-back Pegged All-Poly Glenoids, when used with one of the Select Shoulder Humeral Stems and Humeral Heads, are intended only for use with bone cement in cases of total shoulder arthroplasty for treatment of the following:
- Patient conditions, including but not limited to, noninflammatory degenerative joint > 1. 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-2. 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 3. persists.
- Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the 4. humeral neck, arthrodesis or hemiarthroplasty.
-
- Cuff tear arthropathy.
- Avascular necrosis or osteonecrosis of the humeral head. 6.
- Tumor resection. 7.