The Copeland Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and neck are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis
Correction of functional deformity
Reconstructable rotator cuff
Treatment of fractures of the humeral head
Traumatic arthritis
For cemented use only.

Device Description

These devices are cemented and are designed to maintain maximum bone stock by removing minimal bone and replacing only the defective surface. Copeland Resurfacing Humeral Heads can be used in hemi- or total shoulder replacement surgical procedures. By preserving the bone stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed.
The humeral head components are available in four sizes - small, medium, large, and extra-large. The small, medium, and large humeral heads have the same radius of curvature, but the heights differ to cater for the range of anatomical sizes and offsets. The extra-large head has a larger radius of curvature to accommodate a patient with larger bone stock. The stem is tapered and fluted to provide maximum stability in the humerus. The components are manufactured from cobalt-chrome-molybdenum alloy (ASTM F-75) and coated with MacroBond™ (Ti-Al-4V, ASTM F-1580) on the nonarticulating surface.
The small, medium, and large humeral head components can be used with Biomet's BioModular Glendoids or Integrated Glenoids. The extra-large head can only be used with Biomet's BioModular Glenoids due to the larger spherical radius.

AI/ML Overview

The provided documentation is a 510(k) summary for the Copeland Resurfacing Humeral Heads and does NOT contain information about acceptance criteria or a study proving device performance against such criteria.

The document primarily focuses on:

Device Description: What the device is, its components, materials, and sizes.
Intended Use: The medical conditions it's designed to treat.
Potential Risks: General risks associated with joint replacement devices.
Predicate Device: A similar device previously cleared by the FDA (K003044 - Copeland Resurfacing Heads).
FDA Clearance Letter: Confirmation that the device has been cleared for marketing based on substantial equivalence to the predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text.

To answer your request, information about a specific design validation study, performance metrics, and acceptance thresholds would be required. This type of information is typically found in the full 510(k) submission, specifically in the testing and clinical data sections, which are not included here.

Summary

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APR - 5 2001

SUMMARY OF SAFETY AND EFFECTIVENESS

KO10664

1000

Sponsor:	Biomet, Inc.Airport Industrial ParkWarsaw, Indiana 46580
Contact Person:	Sara A. Bailey(219) 372-1568
Device:	Copeland Resurfacing Humeral Heads
Classification Name:	Shoulder joint metal/polymer/ non-constrained cemented prosthesis
Device Product Code:	KWT (21 CFR 888.3650)

Intended Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis
1. Correction of functional deformity
1. Reconstructable rotator cuff
1. Treatment of fractures of the humeral head
1. Traumatic arthritis

For cemented use only.

Device Description:

The humeral head components are available in four sizes - small, medium, large, and extra-large. The small, medium, and large humeral heads have the same radius of curvature, but the heights differ to cater for the range of anatomical sizes and offsets. The extra-large head has a larger radius of curvature to accommodate a patient with larger bone stock. The stem is tapered and fluted to provide maximum stability in the

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humerus. The components are manufactured from cobalt-chrome-molybdenum alloy (ASTM F-75) and coated with MacroBond™ (Ti-Al-4V, ASTM F-1580) on the nonarticulating surface.

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2017

The small, medium, and large humeral head components can be used with Biomet's BioModular Glendoids or Integrated Glenoids. The extra-large head can only be used with Biomet's BioModular Glenoids due to the larger spherical radius.

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:

l ) Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant.
1. Early or late postoperative infection and allergic reaction.
1. Intraonerative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.
1. Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.
1. Prearticular calcification or ossification, with or without impediment of joint mobility.
1. Inadequate range of motion due to improper selection or positioning of components.
1. Undesirable shortening of limb.
1. Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions.
1. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.
1. Fretting and crevice corrosion can occur at interfaces between components.
1. Wear and/or deformation of articulating surfaces.
1. Accelerated wear of glenoid articular cartilage.
1. Postoperative bone fracture and pain.

Predicate Device(s): Copeland Resurfacing Heads, K003044

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 5 2001

Ms. Sara A. Bailey Regulatory Affairs Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K010664

Trade Name: Copeland Resurfacing Humeral Heads Regulatory Class: II Product Code: HSD and KWT Dated: March 2, 2001 Received: March 6, 2001

Dear Ms. Bailey:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section > rotification of clice in the midications for use to May 28, 1076, the above and we nave delemined the devices marketed in interstate commerce prior to May 28, 1976, the stated in the enclosure) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Dovice Fullendments, or og, and Cosmetic Act (Act). You mays accordance with the provisions of the reachers' room a controls provisions of the Act of devices therefore, market the device, subject to the genirements for annual registration, listing of devices, controls provisions of the Act mende requirentibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into claim additional (casting major regulations).
(Premarket Approval), it may be subject to such additional (Title 21). Register ( (Premarket Apployal), it may of subject to ater a Regulations, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, Pa allecting your device our of round ation assumes compliance with the current Good A Substantially Squrvalent decemmant, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the rood and Drug Nammount in regulatory action. In addition, FDA may publish Contiply with the GMI Yegataton may roundevice in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation your night have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonfication. The I Drice results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Ms. Sara A. Bailey

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 101 in 10 - 10 questions on the promotion and advertising of your device, (2017) 594-4639. Nationally 10. quee at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on your responsibility free number (800) 638-2041 or at (301) 443-6597, or at its İnternet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Millican

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510 (k) Number (if known) : __________________________________________________________________________________________________________________________________________________

Device Name: Copeland Resurfacing Humeral Heads

Indications For Use:

KOID664

1. Non-inflammatory degenerative joint disease including
osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis
1. Correction of functional deformity
1. Reconstructable rotator cuff
1. Treatment of fractures of the humeral head
1. Traumatic arthritis

For cemented use only.

Mark N Mulkeim

(Division Sign-Off) Division of General, Resto tive and Neurological Devices

510(k) Number ___ K010664

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.