(104 days)
Not Found
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.
The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies for an AI device.
The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device called the "CoCr Bi-Angular Humeral Component," which is a shoulder joint prosthesis. It describes the device, its potential risks, and lists commercially available equivalent devices. It also includes a table of reported complications associated with total shoulder arthroplasty, citing various medical literature.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided text.
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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
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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.
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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 humeralhead | 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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§ 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.”