Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Revision where other devices or treatments have failed
Correction of functional deformity
Treatment of acute fracture of the humeral head unmanageable using other treatment methods
Cuff tear arthroplasty
This is a single use implant for use with cemented or uncemented humeral components. It is intended for use with Biomet's humeral components previously cleared by the FDA.

Device Description

The Biomet® Bi-Polar Shoulder Prosthesis is a self-retaining humeral shell that can be used with either the Bi-Angular® humeral prosthesis or the Bio-Modular® humeral prosthesis. In assembling, the liner is place over a modular inner head that is already impacted to an implanted humeral stem. The shell is then placed over the liner and the Ring-Loc lock ring snaps into the outer groove of the liner, which completes assembly of the prosthesis. The shell is available in six spherical diameters, 40 mm, 48 mm, 52 mm, 56 mm and 60 mm. The liner and Ring-Loc® locking ring are modular, i.e. there is only one size of each, and each is used with all six shell sizes.

AI/ML Overview

The provided text describes a medical device submission (K002998) for the Biomet® Bi-Polar Shoulder System. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document is primarily a Notice of Substantial Equivalence from the FDA, indicating that the device is substantially equivalent to a previously marketed predicate device (Biomet® Bi-Polar Shoulder, K991585). This type of FDA clearance (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish efficacy and safety from scratch.

Therefore, I cannot provide the requested information. The text does not elaborate on:

A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented.
Sample size used for the test set and the data provenance: No test set or corresponding data is described.
Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is detailed.
Adjudication method: Not applicable as no ground truth establishment is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
Standalone (algorithm only without human-in-the-loop performance): This device is a physical shoulder prosthesis, not an algorithm, so this is not applicable.
The type of ground truth used: Not applicable as no ground truth assessment is described.
The sample size for the training set: Not applicable as this is a physical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

The document mainly focuses on:

Sponsor and contact information.
Device name and classification.
Intended use and device description.
Potential risks associated with the device (general risks for joint replacement).
Identification of the predicate device.
The FDA's official letter of substantial equivalence.
The Indications for Use statement.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:

Biomet Inc. Airport Industrial Park P.O. Box 587 Warsaw. IN 46581-0587

Contact Person:	Tracy J. Bickel
	(219) 372-1761

Biomet® Bi-Polar Shoulder System Device(s):

Prosthesis, shoulder, non-constrained, metal/polymer, cemented Classification:

Device Product Code: 87 KWT (21 CFR 888.3650) 87 MBF (Unknown, recently down classified)

Intended Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Revision where other devices or treatments have failed
1. Correction of functional deformity
1. Treatment of acute fracture of the humeral head unmanageable using other treatment methods
1. Cuff tear arthroplasty

Device Description:

The Biomet® Bi-Polar Shoulder Prosthesis is a self-retaining humeral shell that can be . used with either the Bi-Angular® humeral prosthesis or the Bio-Modular® humeral prosthesis.
In assembling, the liner is place over a modular inner head that is already impacted to . an implanted humeral stem. The shell is then placed over the liner and the Ring-Loc lock ring snaps into the outer groove of the liner, which completes assembly of the prosthesis.
The shell is available in six spherical diameters, 40 mm, 48 mm, 52 mm, 56 . mm and 60 mm. The liner and Ring-Loc® locking ring are modular, i.e. there is only one size of each, and each is used with all six shell sizes.

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 cement Deformity of the joint Cardiovascular disease

Blood vessel damage Soft tissue imbalance Delayed wound healing

Bone fracture · Infection Hematoma

000171

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Fracture of the cement Implant loosening/migration Tissue growth failure

Metal sensitivity Fracture of the components Nerve damage

Dislocation Excessive wear

Predicate Device(s):

Biomet® Bi-Polar Shoulder, K991585

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT = 6 2000

Ms. Tracy J. Bickel Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K002998

Trade Name: Biomet® Bi-Polar Shoulder Regulatory Class: II Product Code: KWT and MBF Dated: September 18, 2000 Received: September 26, 2000

Dear Ms. Bickel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might 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) 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.

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Page 2 - Ms. Tracy J. Bickel

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours,

Mark N Melkerson

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 of

K002998 510(k) Number (if known): _ Device Name: Biomet® Bi-Polar Shoulder System Indications for Use:

The Biomet® Bi-Polar Shoulder System is indicated for use in:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Revision where other devices or treatments have failed
1. Correction of functional deformity
1. Treatment of acute fracture of the humeral head unmanageable using other treatment methods
1. Cuff tear arthroplasty

This is a single use implant for use with cemented or uncemented humeral components. It is intended for use with Biomet's humeral components previously cleared by the FDA.

Mark n Millerson

vision Sien-Off Division of General Restorative Devices 510(k) Number _

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

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)

0000008

Regulation Number and Section

§ 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.”