BIOMET BIAXIAL TOTAL ELBOW by BIOMET, INC.

The Biomet Biaxial Total Elbow is indicated for use in Rheumatoid Arthritis, Non-Inflammatory Degenerative Joint Disease including Osteoarthritis and Avascular Necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed., and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structures about the elbow.

This device is a single use implant. It is intended for use with bone cement.

Device Description

The Biomet Biaxial Total Elbow Prosthesis is a constrained hinge elbow prosthesis used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two main components, an ulnar and a humeral component which are ioined by a modular connecting piece.

The biaxial elbow is a "loose hinge" type that has a parallel acting second axis of articulation between the ulnar and humeral stems. An inheirent characteristic of the biaxial articulation is that it can vary the anterior-posterior offset between the intramedullary stems. The Biaxial Elbow allows the stem offset to vary because of varying amounts of flexion between the displaced axes of the prosthesis.

The humeral component is a titanium allov stem. The humeral stem incorporates a flange on the anterior side for additional fixation. A portion of the stem and flange are plasma sprayed coated. The remainer of the stem is a bead blast finish. The humeral component utilizes a polyethylene humeral bearing (saddle bearing) to prevent metal on metal contact with the connecting segment.

The ulnar component is titanium alloy stem. A portion of the surface of the ulnar component is textured with a thin layer of Biomet's plasma spray coating (Bondcoat) and the remainer is a bead blast finish. The ulnar component utilizes a polyethylene ulnar bearing (saddle bearing) to prevent metal on metal contact with the connecting segment.

The modular connecting segment is a cobalt chromium allov metallic piece with a polished finish. The connecting segment is joined to the humeral and ulnar stems by means of a sleeve bearing metal reinforcing rod and saddle bearing. The metal reinforcing rod or axle assembly is manufactured from cobalt chromium. The axles are sleeved by axle bearings, which are manufactured from ArCom® (ultra high molecular weight polyethylene (UHMWPE)). The axle retaining clips are manufactured from titanium alloy. The saddle bearings of the humeral and ulnar component are manufactured from Arcom.

AI/ML Overview

The provided text describes a medical device, the Biomet Biaxial Total Elbow, and its substantial equivalence to other marketed devices. It outlines the intended use, device description, and potential risks. However, the document does not contain information typically found in acceptance criteria or studies proving device performance for most of the requested parameters. This kind of information is usually detailed in pre-clinical testing reports (e.g., mechanical tests, biocompatibility tests) or clinical studies, which are not included in this summary of safety and effectiveness.

Here's an analysis based on the available text:

Acceptance Criteria and Device Performance Study Information

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or reported device performance data in a quantitative or tabular format. It generally states that the device is "substantially equivalent" to predicate devices, implying it meets similar safety and effectiveness standards, but it doesn't detail what those standards are or how it explicitly performs against them.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes the device and its intended use but does not present data from a test set or clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. No test set or ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The device is a physical elbow prosthesis, not an AI-assisted diagnostic or therapeutic tool, so an MRMC study related to AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document. As mentioned above, this is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. No specific ground truth related to device performance is discussed. The "substantial equivalence" determination by the FDA is based on a review of the device's design, materials, and intended use compared to legally marketed predicate devices, not typically on a new ground truth evaluation through clinical trials for 510(k) clearances unless specific performance data is required for a novel aspect.

8. The sample size for the training set

This information is not provided in the document. No training set is mentioned as this is a physical medical device clearance, not an AI model development.

9. How the ground truth for the training set was established

This information is not provided in the document. No training set or ground truth establishment for a training set is discussed.

Summary of what is present:

The document is a FDA 510(k) Summary of Safety and Effectiveness for a medical device. It provides:

Device Name: Biomet Biaxial Total Elbow
Intended Use: Rheumatoid Arthritis, Non-Inflammatory Degenerative Joint Disease, correction of severe functional deformity, revision procedures, and treatment of acute/chronic fractures with humeral epicondyle involvement.
Device Description: A constrained hinge elbow prosthesis with humeral and ulnar components joined by a modular connecting piece, designed as a "loose hinge." Details on materials (titanium alloy, polyethylene, cobalt chromium) are provided.
Potential Risks: Standard risks associated with joint replacement (e.g., reaction to bone cement, fracture of components, infection, loosening).
Substantial Equivalence: States the device is substantially equivalent to predicate devices like the Coonrad III Total Elbow (Zimmer) and Osteonics Elbow Prosthesis. This is the primary "proof" for 510(k) clearance – demonstrating that the new device is as safe and effective as a legally marketed predicate device.

What is generally expected for acceptance criteria and performance evidence for this type of device (though not present in this document):

For a joint prosthesis like the Biomet Biaxial Total Elbow, acceptance criteria and performance studies typically involve:

Mechanical Testing: Benchtop tests for fatigue, wear, strength, range of motion, and constraint, adhering to ISO or ASTM standards. Acceptance criteria would be specific load cycles, wear rates (e.g., < X mg/million cycles), or force thresholds.
Biocompatibility Testing: In vitro and in vivo tests to ensure materials are non-toxic and do not cause adverse reactions.
Sterilization Validation: Proof that the sterilization process is effective.
Design Validation: Often through a risk analysis and ensuring the design addresses identified risks.
Clinical Data (if required): For 510(k) devices, clinical data is not always required if substantial equivalence can be demonstrated through non-clinical means. If clinical data were gathered, then parameters like patient reported outcomes (PROMs), range of motion, pain scores, revision rates, and adverse event profiles would be evaluated against pre-defined acceptance criteria, potentially involving sample sizes of patients followed prospectively. However, this document does not mention such a clinical study.

Summary

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5 1000 MAY SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:	Biomet, Inc.Airport Industrial ParkWarsaw, Indiana 46580
Device:	Biomet Biaxial Total Elbow
Classification Name:prosthesis. (888.3150)	Elbow joint metal/polymer constrained cemented

K980428Intended Use: The Biomet Biaxial Total Elbow is indicated for use in Rheumatoid Arthritis, Non-Inflammatory Degenerative Joint Disease including Osteoarthritis and Avascular Necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed., and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structures about the elbow.

This device is a single use implant. It is intended for use with bone cement.

Device Description: The Biomet Biaxial Total Elbow Prosthesis is a constrained hinge elbow prosthesis used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two main components, an ulnar and a humeral component which are ioined by a modular connecting piece.

Image /page/0/Picture/9 description: The image shows the number 000076 in a bold, sans-serif font. The numbers are black against a white background. The image is slightly tilted.

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reinforcing rod or axle assembly is manufactured from cobalt chromium. The axles are sleeved by axle bearings, which are manufactured from ArCom® (ultra high molecular weight polyethylene (UHMWPE)). The axle retaining clips are manufactured from titanium alloy. The saddle bearings of the humeral and ulnar component are manufactured from Arcom.

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 Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement Dislocation

Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Breakdown of porous surface
Substantial Equivalence: In function and overall design Biomet's Biaxial Total Elbow is equivalent to almost all elbow joint metal/polymer constrained cemented prostheses on the market. Predicate devices include:

Coonrad III Total Elbow (Zimmer, 510(k) #K883665) Osteonics Elbow Prosthesis (Osteonics Corp., 510(k) #K861680)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1698 MAY

Deborah M. Matarazzo R.N., B.S.N. Clinical Research Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

Re : K980428 Biomet Biaxial Total Elbow Trade Name: Requlatory Class: III Product Code: JDC Dated: January 29, 1998 Received: February 4, 1998

Dear Ms. Matarazzo:

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 controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸ 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 Reqister. 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 requlations.

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Page 2 - Deborah M. Matarazzo R.N., B.S.N.

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.

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 yours,

Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative 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): K980428

Device Name: Biomet Biaxial Total Elbow

Indications For Use: The Biaxial Hinge Total Elbow is indicated for use in Rheumatoid Arthritis, Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structure about the elbow.

This device is a single use implant. It is intended for use with bone cement.

(PLEASE DO NOT WRITE BETON THIS LINE - CONTINUE ON ANOTHER PAGE IN NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

tcolly

Division Sign-Off)
Division of General Restorative Devices
10(k) Number. K980428

Regulation Number and Section

§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,”
(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,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”