(84 days)
No
The 510(k) summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is a permanent implant (shoulder replacement system) and not a therapeutic device for short-term use.
No
Explanation: The device is a shoulder replacement system (implant) used for treatment, not for diagnosis. Its purpose is to repair rather than to identify a condition.
No
The device description clearly outlines physical components (humeral head components, stem) made of Co-Cr-Mo material, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant used for shoulder replacement. It is a physical device implanted into the body to restore function to the shoulder joint.
- Intended Use: The intended use is for hemi- or total shoulder replacement in patients with specific conditions like cuff tear arthropathy. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The description clearly indicates a device that is surgically implanted, which falls under the category of implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Copeland™ Extended Articulating Surface (EAS) Resurfacing Heads are indicated for hemi- or total shoulder replacement in patients with massive, irreparable rotator cuff tears and arthritis. Specific indications Include:
- Cuff tear arthropathy.
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
Implants with Interlok®/hydroxyapatite coating are cleared for uncemented applications. Implants with MacroBond® and MacroBond® coating with hydroxyapatite are cleared for cemented and uncemented applications; however, cement should only be applied to the surfaces that do not contain hydroxyapatite coating (i.e. stem).
Product codes
HSD, KWS, KWS, KWT, MBF
Device Description
These devices are intended for use in patients with an irreparable rotator cuff as a shoulder replacement system that requires minimal bone resection. The Co-Cr-Mo Copeland™ EAS Resurfacing Heads can be used in hemi- or total shoulder replacement surgical procedures in patients experiencing pain and disability of the gleno-humeral joint. By preserving the bone stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed. This device can easily be revised to a longer stemmed prosthesis, if necessary, due to the initial bone preservation.
The humeral head components are available in eight (8) sizes (1-8). The Copeland™ EAS Resurfacing Heads have a variable spherical radii that range fro 20mm to 27mm. The stem is tapered and fluted to provide maximum stability in the humerus.
The most notable landmark on the Copeland™ EAS Humeral Resurfacing Head is the addition of material to the superior-lateral side of the resurfacing head. This material is added to keep the implant surface in contact with the acromion longer, reducing pain and increasing the amount that the arm can be raised in patients with rotator cuff deficiency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint humeral (hemi-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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Bio-Modular® EAS Heads- K030710, Copeland™ Resurfacing Heads - K010657, Global™ Advantage Extended Humeral Heads - K000575, Global™ C.A.P. Resurfacing Replacement Shoulder- K031971
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered in the image. The font is a serif font, and the text is black. The background is white.
Image /page/0/Picture/12 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
FEB - 9 2006
Public Health Scrvice
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
Ms. Tracy Bickel Johnson, RAC Manager of Regulatory Affairs Biomet, Inc. 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K051843 Trade/Device Name: Copeland" EAS Humeral Resurfacing Heads Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Codes: HSD, KWS, KWS, KWT, MBF Dated: July 5, 2005 Received: July 7, 2005
Dear Ms. Johnson:
This letter corrects our substantially equivalent letter of September 29, 2005.
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. Drug. 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 device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA 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
1
Page 2- Ms. Tracy Bickel Johnson, RAC
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 1000-1050. 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 (301) 443-6597 or at its Internet address ltttp://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
2
ా Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): _K051843
Device Name: Copeland™ EAS Humeral Resurfacing Heads
Indications For Use:
The Copeland™ Extended Articulating Surface (EAS) Resurfacing Heads are indicated for hemi- or total shoulder replacement in patients with massive, irreparable rotator cuff tears and arthritis. Specific indications Include:
-
- Cuff tear arthropathy.
-
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
Implants with Interlok®/hydroxyapatite coating are cleared for uncemented applications. Implants with MacroBond® and MacroBond® coating with hydroxyapatite are cleared for cemented and uncemented applications; however, cement should only be applied to the surfaces that do not contain hydroxyapatite coating (i.e. stem).
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Wilkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051843
Page 1 of 1
3
.f 2-
510(k) Summary
- Biomet Manufacturing, Corp. Sponsor: P.O. Box 587 Warsaw, IN 46581-0587
- Contact Person: Tracy Bickel Johnson, RAC Manager, Requlatory Affairs Biomet Manufacturing Corp. (574) 267-6639
Proprietary Name: Copeland™ EAS Humeral Resurfacing Heads
Common Name: Resurfacing head
Classification Name(s):
-
Prosthesis, shoulder, semi-constrained, metal/polymer cemented (888.3660)
-
Prosthesis, shoulder, non-constrained, metal/polymer uncemented (888.3650)
-
Prosthesis, shoulder, semi-constrained, metal/polymer uncemented (888.3670)
- Prosthesis, shoulder, hemi-, humeral, metallic uncemented (888.3690) ो
Bio-Modular® EAS Heads- K030710 (Biomet); Substantially Equivalent Devices: Copeland™ Resurfacing Heads - K010657 (Biomet); Global™ Advantage Extended Humeral Heads - K000575 (DePuy); Global™ C.A.P. Resurfacing Replacement Shoulder- K031971 (DePuy)
Device Description:
These devices are intended for use in patients with an irreparable rotator cuff as a shoulder replacement system that requires minimal bone resection. The Co-Cr-Mo Copeland™ EAS Resurfacing Heads can be used in hemi- or total shoulder replacement surgical procedures in patients experiencing pain and disability of the gleno-humeral joint. By preserving the bone stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed. This device can easily be revised to a longer stemmed prosthesis, if necessary, due to the initial bone preservation.
The humeral head components are available in eight (8) sizes (1-8). The Copeland™ EAS Resurfacing Heads have a variable spherical radii that range fro 20mm to 27mm. The stem is tapered and fluted to provide maximum stability in the humerus.
The most notable landmark on the Copeland™ EAS Humeral Resurfacing Head is the addition of material to the superior-lateral side of the resurfacing head. This material is added to keep the implant surface in contact with the acromion longer, reducing pain and increasing the amount that the arm can be raised in patients with rotator cuff deficiency.
4
510(k) Summary- Page 2 of 2 Biomet Manufacturing Corp. Copeland™ EAS Humeral Resurfacing Heads
Indications for Use:
The Copeland™ Extended Articulating Surface (EAS) Resurfacing Heads are indicated for hemior total shoulder replacement in patients with massive, irreparable rotator cuff tears and arthritis. Specific indications include:
-
- Cuff tear arthropathy.
-
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
Implants with Interlok®/hydroxyapatite coating are cleared for uncemented applications. Implants with MacroBond® and MacroBond® coating with hydroxyapatite are cleared for cemented and uncemented applications; however, cement should only be applied to the surfaces that do not contain hydroxyapatite coating (i.e. stem).
Summary of Technologies: Combined designs (Bio-Modular® EAS Heads- K030710 and Copeland™ Resurfacing Heads - K010657) were used to develop the Copeland™ Extended Articulating Surface (EAS) Resurfacing Heads.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.