(109 days)
K / DEN: Not Found
Not Found
No
The summary describes a mechanical implant system for shoulder arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a prosthetic system (humeral prosthesis, total shoulder arthroplasty) intended to replace damaged anatomical structures to treat various severe shoulder conditions, which falls under the definition of a therapeutic device.
No
The description indicates that the device is a shoulder prosthesis (Proximal Humeral Prosthesis and Total Shoulder Arthroplasty), used to replace damaged shoulder joints. It is used for treatment of various shoulder conditions, not for diagnosing them.
No
The device description clearly states it consists of physical components (Stem, Head, Glenoid) made of materials like Co-Cr-Mo and UHMWPE, indicating it is a hardware device.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Cofield Modular Shoulder System is a surgical implant designed to replace or repair damaged shoulder joints. It is used in vivo (within the body) during surgery.
- Lack of Diagnostic Function: The device's purpose is to provide structural support and restore function to the shoulder joint, not to diagnose any condition by analyzing biological samples.
Therefore, the Cofield Modular Shoulder System falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cofield Modular Shoulder System is indicated for the following use: Proximal Humeral Prosthesis 1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part injuries in the Neer classification, or headsplitting, or head impression fractures). 2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures. 3. Avascular necrosis with intact glenoid cartilage. 4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities. Total Shoulder Arthroplasty Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The device is intended only for use with bone cement and is a single use device.
Product codes
Not Found
Device Description
The Cofield Modular Shoulder System consists of the following components: Stem component Head component Glenoid UHMWPE component The humeral components are fabricated from Co-Cr-Mo. The porous coating on the undersurface of the collar of the stem is fabricated from Co-Cr-Mo beads. The glenoid component is manufactured from UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder Joint
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was performed according to the requirements of FDA guidance documents and met or exceeded acceptable performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
- Biomet Biomodular Total Shoulder
- DePuy Global Total Shoulder
- Orthomet 3M Neer II and Modular Shoulder
- Zimmer Fenlin Total Shoulder
- Kirschner Modular II-C
- Intermedics Select Shoulder System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Smith & Nephew Orthopaedic Implant Division
a division of Smith & Nephew Richards Inc. 1450 Brooks Road, Memphis, TN 38116 Telephone: 901-396-2121
APR - 8 1996
Smith ╬ Nephew
Thomas L. Craig Director, Regulatory and Clinical Affairs Orthopaedics Smith & Nephew Richards Inc. 1450 Brooks Road Memphis. TN 38115 Telephone: (901) 396-2121 Fax: (901) 398-5146
Summary of Safety and Effectiveness Smith & Nephew Richards Inc. Cofield Modular Shoulder System October 20, 1995
Trade Name - Cofield Modular Shoulder System Common Name - modular shoulder system Classification Name - Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR 888.3660
Substantial Equivalent Information
The Cofield Modular Shoulder System is similar to the following shoulder systems:
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- Biomet Biomodular Total Shoulder
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- DePuy Global Total Shoulder
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- Orthomet 3M Neer II and Modular Shoulder
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- Zimmer Fenlin Total Shoulder
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- Kirschner Modular II-C
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- Intermedics Select Shoulder System
All the devices listed above are indicated for total shoulder replacement and are indicated for use with cement. They are all similar to the design of the Cofield Modular Shoulder. The safety and effectiveness of the Cofield Modular Shoulder are based on the long history of use of these devices in the market place.
Device Description
The Cofield Modular Shoulder System consists of the following components:
Stem component Head component Glenoid UHMWPE component
1
The humeral components are fabricated from Co-Cr-Mo. The porous coating on the undersurface of the collar of the stem is fabricated from Co-Cr-Mo beads. The glenoid component is manufactured from UHMWPE.
Indications for Use
The Cofield Modular Shoulder System is indicated for the following use:
Proximal Humeral Prosthesis
-
- Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part injuries in the Neer classification, or headsplitting, or head impression fractures).
-
- Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
-
- Avascular necrosis with intact glenoid cartilage.
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- Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities.
Total Shoulder Arthroplasty
Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.
The device is intended only for use with bone cement and is a single use device.
Mechanical Testing
Mechanical testing was performed according to the requirements of FDA guidance documents and met or exceeded acceptable performance.