The components of Bi-Anqular® Shoulder System included in this submission are intended for hemi- or total shoulder joint arthroplasty. Indications for use include:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Revision where other devices or treatments have failed
Correction of functional deformity
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene components are indicated for cemented application only.

Device Description

The Bi-Anqular® Shoulder System is composed of a titanium alloy humeral stem with a modular humeral head which is designed to articulate with an all polyethylene qlenoid component or the natural glenoid bone in a hemi-shoulder configuration. There is no linkage across the joint.

The proximally tapered, collarless stem follows the natural contours of the humeral canal thus promoting evenly distributed stress off-loading. Cylindrical distal stems fill the humeral canal. Proximal fins contribute to rotational stability while suture holes in the fins allow for proximal reconstruction of complex humeral fractures. Durinq insertion, a K-wire can be placed into the version hole in the medial calcar region of the stem to allow exact version control of the component referencing off the patient's forearm.

Proximal porous coating on the humeral stem provides for biological fixation when used without bone cement. Non-porous humeral stems are available for cemented use.

The humeral component utilizes a modular head which is taper-fit onto the stem at the time of surgery.

The all polyethylene glenoid component has an angled triangular shaped keel which can be trimmed during surgery.

AI/ML Overview

The presented document is a 510(k) premarket notification for a medical device, the Bi-Angular® Shoulder System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics.

Therefore, the document explicitly states: "Clinical Testing: None provided."

Based on this, it's not possible to provide the requested information regarding acceptance criteria and performance studies because no clinical studies were conducted or provided in this 510(k) submission. The FDA's determination was based on substantial equivalence to existing predicate devices and non-clinical mechanical testing, not on clinical performance against specific acceptance criteria.

Summary

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K032895

NOV 2 0 2003

Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics Inc. The logo is in black and white and features the word "BIOMET" in a stylized font. Below the word "BIOMET" is the phrase "ORTHOPEDICS INC." in a smaller, sans-serif font. The logo is simple and modern.

Summary of Safety and Effectiveness

Applicant/Sponsor:Biomet Orthopedics, Inc.

Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist

Proprietary Name: Bi-Angular® Shoulder System

Common or Usual Name: Total shoulder replacement components

Classification Name:

1. Prosthesis, Shoulder, non-constrained, Cemented (21 CFR Section 888,3650)
1. Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented (21 CFR Section 888.3660)
1. Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Uncemented (21 CFR Section 888.3670)
1. Prosthesis, Shoulder, Hemi-, Humeral, Metallic, Cemented or Uncemented (21 CFR Section 888.3690)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Bio-Modular® Shoulder System - K030710 Proximal Humeral Component - K925613

Device Description: The Bi-Anqular® Shoulder System is composed of a titanium alloy humeral stem with a modular humeral head which is designed to articulate with an all polyethylene qlenoid component or the natural glenoid bone in a hemi-shoulder configuration. There is no linkage across the joint.

Proximal porous coating on the humeral stem provides for biological fixation when used without bone cement. Non-porous humeral stems are available for cemented use.

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SHIPPING ADDRE Airport Inclustrial Park Warsaw, IN 46580

biomet@biome1.com

OFFICE -

267 (1633)

MAILING ADDRESS

P.O. Box 587

Warsaw, IN 46581 0587

FAX

219.267.8137

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The humeral component utilizes a modular head which is taper-fit onto the stem at the time of surgery.

The all polyethylene glenoid component has an angled triangular shaped keel which can be trimmed during surgery.

Intended Use: The components of Bi-Anqular® Shoulder System included in this submission are intended for hemi- or total shoulder joint arthroplasty. Indications for use include:

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. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (Interlok®) and polyethylene components not attached to a metal backi are indicated for cemented application only.

Summary of Technologies: The materials, surface finishes and processing of the Bi-Angular® Shoulder System are similar to the predicate device.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. A full characterization of the porous surface was provided.

Clinical Testing: None provided

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All trademarks are property of Biomet, Inc.

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NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K032895

Trade/Device Name: Bi-Angular® Shoulder System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or seni-constrained porous-coated uncemented prosthesis. Regulatory Class: II Product Code: MBF Dated: September 16, 2003 Received: September 17, 2003

Dear Ms. Beres:

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 10 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 max publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 1000-1050.

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Page 2 - Ms. Patricia Sandborn Beres

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 (301) 594-4659. 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 http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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K037895 510(k) Number (if known):

Device Name: Bi-Anqular® Shoulder System

Indications For 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. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

(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
Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devic

510(k) Number K032895

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.”