ABC TOTAL ELBOW PROTHESIS by BIOMET, INC.

The ABC Elbow Prothesis 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 device is a single use implant. It is intended for use with bone cement.

Device Description

The ABC elbow is a total elbow prothesis. The implant consists of two components, an ulna and a humeral component.

The ulna is made up of two elements, the polyethylene articulating surface and the titanium stem. The polyethylene is compression molded onto the substrate. The articulating section is formed like part of a cylinder, the inner part being the polyethylene bearing and the outer being the substrate. The ulna component is designed to match the existing trochlea anatomy. This conserves bone and will improve the ease of implant alignment and fixation.

The substrate is roughened to enhance fixation to the cement interface. The stem is shaped to approximate to the internal geometry of the proximal ulna at the trochlea. The stem may be coated with a titanium plasma spray to provide additional cement fixation. The inner surface of the implant, the polyethylene bearing, is radiused in both axes.

The humeral component is a one piece cobalt chrome casting. The barrel is open ended and this matches the bone cut on the distal anterior humerus. The open section has been thickened internally to compensate for mechanical weakening caused by the removal of the closing section of the barrel. The transition from the barrel has been profiled to match the natural anatomy of the olecranon fossa. The support of the inside of the barrel and the gradual transition from barrel to stem ensure the mechanical strength of the barrel is not compromised. It requires less bone removal to implant the humeral component and the stem is designed to match the natural anatomy of the olecranon fossa and the surrounding borders.

AI/ML Overview

This document, K972691, is a 510(k) premarket notification for a medical device called the "ABC Total Elbow Prothesis." It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document. The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is "substantially equivalent" in safety and effectiveness to a legally marketed predicate device, not necessarily to prove performance against pre-defined acceptance criteria through a clinical or performance study in the way a PMA (Premarket Approval) might require.

The document mainly covers:

Device Description: Details about the ABC Total Elbow Prothesis (ulnar and humeral components).
Intended Use: The medical conditions for which the device is indicated.
Potential Risks: General risks associated with joint replacement.
Substantial Equivalence: A list of predicate devices to which the ABC Total Elbow Prothesis is compared.
FDA Communication: The FDA's letter granting clearance based on the determination of substantial equivalence.

There is no mention of:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or data provenance.
Number of experts or their qualifications for ground truth.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used (pathology, outcomes data, etc.).
Training set sample size or how its ground truth was established.

Summary

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OCT 1 5 1997

K972691

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SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580

Device: ABC Total Elbow Prothesis

Classification Name: Elbow joint metal/polymer semi-constrained cemented prothesis. (888.3160)

Intended Use: The ABC (Anatomical Bone Conserving) Elbow Prothesis is indicated for use in Rheumatoid Arthritis, Non-Inflammatory degenerative join 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 device is a single use implant. It is intended for use with bone cement.

Device Description: The ABC elbow is a total elbow prothesis. The implant consists of two components, an ulna and a humeral component.

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SHIPPING ADDRESS

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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 Tissue growth failure Delaved wound healing Fracture of the cement

Bone Fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation Metal sensitivity Breakdown of porous surface

Substantial Equivalence: The ABC Total Elbow Prothesis is substantially equivalent to almost all elbow devices on the market in overall design and intended function. Predicate devices include:

Sorbie-Questor Total Elbow System (Wright Medical, 510(k) #K955099) Osteonics Elbow Prothesis (Osteonics, 510(k) #K861680) Coonrad III Total Elbow (Zimmer, 510(k) #K883665) Pritchard Elbow (Depuy, 510(k) #K810847) Surface Replacement Elbow (Howmedica, 510(k) # K820957) Capitello Condylar (Johnson & Johnson, Preamendment?)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kara Mezger Glinical Research Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

OCT 1 5 1997

K972691 Re: Biomet IBC Elbow Prosthesis (Originally Submitted as ABC Total Elbow Prosthesis Regulatory Class: II Product Code: JDB Dated: July 16, 1997 Received: July 17, 1997

Dear Ms. Mezger:

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Ms. Kara Mezger

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,

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

Enclosure

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510(k) Number (if known): K972691

Device Name: ABC Total Elbow Prothesis

Indications For Use:

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

(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)

ﻤﻌﺎﻣﺔ

Over-The-Counter Use_

(Optional Format 1-2-96)

Division of General Restorative Devices 510(k) Number_K47269 |

Regulation Number and Section

§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.