(79 days)
Not Found
No
The summary describes a mechanical implant system for shoulder arthroplasty and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is a prosthetic shoulder system intended to replace damaged humeral and glenoid articular surfaces, alleviating pain and restoring function in patients with severe joint destruction or fractures. This directly treats a disease or condition, fitting the definition of a therapeutic device.
No
The device is described as a "Total Shoulder System" for arthroplasty and treatment of shoulder conditions, indicating it is a prosthetic implant for surgical reconstruction, not a diagnostic tool.
No
The device description clearly states it is a "Total Shoulder System" and refers to "components" and "materials," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the shoulder joint due to various conditions like fractures, arthritis, and avascular necrosis. This is a therapeutic device, not a diagnostic one.
- Device Description: The description talks about components and materials of a shoulder system, which are physical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
- Anatomical Site: The device is used directly on the shoulder joint, which is an in-vivo application, not in-vitro (outside the body).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cofield2 Total Shoulder System is indicated for the following:
Proximal Humeral Prosthesis
- Complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma -- three and four-part 1. injuries in the Neer classification or head splitting, or head impression fractures).
- Informer in the read easily ar fracture-dislocations of the humeral head with malunion, non-union of a 2. small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
- Avascular necrosis with intact glenoid cartilage. 3.
- Avaschal necross with mast growers and have adequate scapular bone to support a glenoid component 4. or must engage in moderately heavy activities.
Total Shoulder Arthroplasty
I our Shounder Articular surfaces with intractable chronic pain in rheumatoid arthritis. juvenile rheumatoid arthritis, osteoarthritis, traumatic arthroplasty, ancient septic arthritis, Javenne mechanism athansis glenoid changes, radiation necrosis, and other failed reconstructive procedures.
The Cofield2 Total Shoulder System includes porous coated devices which are intended for use without bone cement, and are single use devices.
Product codes (comma separated list FDA assigned to the subject device)
MBF
Device Description
The overall design, components, and materials of the Cofield Total Shoulder System are substantially equivalent to the existing components of the Cofield Total Shoulder System cleared under previous cquirvation to the 'existing components of between the subject components of the Cofield Total Shoulder premanet notified on the currently is the intended use of the system without bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, humeral head, glenoid
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K955767, K003566, K011099, K030710
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement 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 (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
0
K07a565
510(k) Summary Smith and Nephew Cofield2 Total Shoulder System
| Submitter's Name: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| Submitter's Address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's Telephone Number: | 901-399-6055 |
| Contact Person: | Marlon D. Ridley |
| Date Summary Prepared: | February 27, 2007 |
| Trade or Proprietary Device Name: | Smith & Nephew Cofield² Total Shoulder System |
| Common or Usual Name: | Shoulder Joint Prosthesis |
| Classification Name: | Shoulder Joint Metal/Polymer/Metal Nonconstrained or |
| Semi-Constrained Porous-Coated Uncemented | |
| Prosthesis | |
| Device Class: | Class II |
| Panel Code: | MBF Orthopaedics/ 87 |
| Classification Name: | 21 CFR 888.3670 - Shoulder joint metal/polymer/metal |
| nonconstrained porous-coated uncemented prosthesis. |
Device Intended Use
The Cofield2 Total Shoulder System is indicated for the following:
Proximal Humeral Prosthesis
- Complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma -- three and four-part 1. injuries in the Neer classification or head splitting, or head impression fractures).
- Informer in the read easily ar fracture-dislocations of the humeral head with malunion, non-union of a 2. small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
- Avascular necrosis with intact glenoid cartilage. 3.
- Avaschal necross with mast growers and have adequate scapular bone to support a glenoid component 4. or must engage in moderately heavy activities.
Total Shoulder Arthroplasty
I our Shounder Articular surfaces with intractable chronic pain in rheumatoid arthritis. juvenile rheumatoid arthritis, osteoarthritis, traumatic arthroplasty, ancient septic arthritis, Javenne mechanism athansis glenoid changes, radiation necrosis, and other failed reconstructive procedures.
The Cofield2 Total Shoulder System includes porous coated devices which are intended for use without bone cement, and are single use devices.
Device Description
Device Description
The overall design, components, and materials of the Cofield Total Shoulder System are substantially equivalent to the existing components of the Cofield Total Shoulder System cleared under previous cquirvation to the 'existing components of between the subject components of the Cofield Total Shoulder premanet notified on the currently is the intended use of the system without bone cement.
Substantially Equivalent
Cofield2 Total Shoulder System - Smith & Nephew (K955767) Coffeld2 Eccentric and Lateral Offset Humeral Heads - Smith & Nephew (K003566) Global 134 Fx Porous-Coated Humeral Stem - Depuy Orthopaedics (K011099) Bio-Modular® Shoulder System -- Biomet Orthopedics (K030710)
Image /page/0/Picture/17 description: The image shows a series of vertical black and white stripes. The stripes vary in width and spacing, creating a pattern that resembles a barcode. The overall impression is one of organized chaos, with the contrasting colors and irregular widths adding visual interest.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc % Mr. Marlon D. Ridlev Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
MAY 1 8 2007
Re: K070565
Trade/Device Name: Smith & Nephew Cofield2 Total Shoulder System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal unconstrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: II
Product Code: MBF Dated: February 26, 2007 Received: February 28, 2007
Dear Mr. Ridley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Trug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devise can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-11050.
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Page 2 - Mr. Marlon D. Ridley
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Sincerely yours,
Mark N. Malkerson
Mark N. Melkerson Dirèctor Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew Cofield2 Total Shoulder System
Indications for Use:
The Cofield2 Total Shoulder System is indicated for the following:
Proximal Humeral Prosthesis
-
- Complex, acute fractures or fracture-dislocations of the humeral head (e.g. frauma three and four-part injuries in the Neer classification or head splitting, or head impression fractures).
-
- Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union 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. ဒေ
- বা Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or 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 Cofield Total Shoulder System includes porous coated devices which are intended for use without bone cement, and are single use devices.
Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence,
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Division of General, Restorative, and Neurological Devices
510(k) Number K070565