(104 days)
No
The device description details a mechanical implant (humeral stem) with no mention of software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The description focuses on material properties, geometry, and sizes.
No
The device is described as a humeral stem designed to articulate with a glenoid component, used for reconstruction of complex humeral fractures. This indicates it is a prosthetic implant for structural support and joint function, which is a therapeutic purpose. However, the FDA classifies a "therapeutic device" as one that delivers some form of therapy (e.g., electrical stimulation, light therapy). A prosthetic implant, while treating a condition, is generally classified as a "prosthesis" or "implant" rather than a "therapeutic device" in the strictest regulatory sense unless it also performs an active therapeutic function. Based solely on the provided description, it does not actively deliver therapy.
No
The device described is a humeral stem, which is an orthopedic implant for the shoulder, not a tool for diagnosing medical conditions.
No
The device description clearly describes a physical, metallic humeral stem, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases or other conditions.
- Device Description: The description clearly states the device is a "metallic humeral stem" designed to be implanted in the shoulder joint. This is an implantable medical device, not a diagnostic test performed on a sample outside the body.
- Intended Use/Indications for Use: While not explicitly stated, the description of the device as a humeral stem for articulation with a glenoid component strongly suggests its use in shoulder replacement surgery, which is a therapeutic procedure, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological samples, which are characteristic of IVD devices.
Therefore, this device falls under the category of a surgical implant rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The device is composed of a metallic humeral stem which is designed to articulate with a commercially available glenoid component. There is no linkage across the joint. The tapered collarless stem follows the natural contours of the canal; the tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. Proximal fins contribute to maximize rotational stablity while suture holes in the fins allows for proximal reconstruction of complex humeral fractures. The stem is "grit blasted" for a roughened surface of 200 microinches which provides for an improved fixation between the stem/coment interface. Stems are available in 7 sizes with diameters ranging from 6.5mm to 15.5mm in 1.5mm increments at a length of 115mm. for primary use. Revision stems are available in a range of diameters of 8.0mm to 1.5mm increments at a lenath of 190mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
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
961571
AUG - 5 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor:
Biomet. Inc. Airport Industrial Park Warsaw, Indiana 46580
Device: CoCr Bi-Anquiar Humeral Component
Classification Name: Shoulder Joint Non-Constrained Metal/Polymer Cemented Prosthesis
Device Description: The device is composed of a metallic humeral stem which is designed to articulate with a commercially available glenoid component. There is no linkage across the joint.
The tapered collarless stem follows the natural contours of the canal; the tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. Proximal fins contribute to maximize rotational stablity while suture holes in the fins allows for proximal reconstruction of complex humeral fractures. The stem is "grit blasted" for a roughened surface of 200 microinches which provides for an improved fixation between the stem/coment interface.
Stems are available in 7 sizes with diameters ranging from 6.5mm to 15.5mm in 1.5mm increments at a length of 115mm. for primary use. Revision stems are available in a range of diameters of 8.0mm to 1.5mm increments at a lenath of 190mm.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
- Reaction to bone coment Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delayed wound healing Fracture of the cement
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation Metal sensitivity
1
Substantial Equivalence: In function and overall design Blomet's CoCr Bi-Angular Humeral Component is equivalent to almost all shoulder components on the market.
Commercially available shoulder devices include:
Atlas Shoulder, Kirschner, 510(k)# K940537 cleared for marketing 29 August, 1995.
Neer Shoulder, Kirschner, 510(k)# K873073 cleared for marketing 1 October, 1987. Bi-Angular Shoulder, Biomet, 510(k)# K872454 cleared for marketing 27 August, 1987.
2
Reported Complication of Total Shoulder Arthroplasty
. (
| Complication | Citation |
|---|---|
| Glenoid loosening | Gristina (1987), Cofield (1984), Brenner, Neer (1962), Barrett |
| (1967), Warren, Thomas, Kelly (1987), Friedman (1989), Roper, | |
| Hawkins (1989), Averill, Pahle, Boyd (1991), Wilde (1984), | |
| Amstutz (1988), Friedman (1986), Pritchett | |
| Component instability | Gristina (1987), Cofield (1984), Brenner, Neer (1962), Fleega, |
| Barrett (1987), Roper, Hawkins (1989), Averill, Pahle, Wilde | |
| (1984), Amstutz (1988), Clayton, Pritchett | |
| Rotator cuff deficiency or tearing | Cofield (1984), Neer (1982), Fleega, Warren, Kelly (1987), |
| Figgie | |
| Humeral component loosening | Gristina (1987), Neer (1982), Barrett (1987), Warren, Boyd |
| (1991), Amstutz (1988) | |
| Infection | Gristina (1987), Neer (1982), Roper, Pahle, Kelly (1990), Wilde |
| (1984), Amstutz (1988) | |
| Bone fracture | Brenner, Neer (1962), Barrett (1967), Warren, Thomas, Kelly |
| (1987), Hawkins (1989), Averill, Pahle, Kelly (1990), Boyd | |
| (1991), Amstutz (1988), Pritchett | |
| Humeral Subsidence | Kelly (1990), Boyd (1991) |
| Impingement | Barrett (1987), Warren, Wilde (1984) |
| Pain | Barrett (1987), Copeland |
| Heterotopic bone formation | Wilde (1984) |
| Superior migration of the humeral | |
| head | Brenner, Thomas, Kelly (1967), Hawkins (1989), Averill, Boyd |
| (1991), Amstutz (1988), Pritchett | |
| Tuberosity nonunion | Cofield (1984), Neer (1982) |
| Excessive bleeding | Warren |
| Nerve laceration or injury | Gristina (1987), Cofield (1984), Barrett (1987), Warren, |
| Averill, Boyd (1991), Pritchett | |
| Hematoma | Cofield (1984) |
| Wound healing | Figgie |
| Muscle weakness | Copeland, Figgie |
| Reflex sympathetic dystrophy | Cofield (1984) |
| Pulmonary embolism | Cofield (1984) |
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