MAXIM REMOVABLE MOLDED POLY TIBIA by BIOMET, INC.

Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.

Device Description

The Maxim Removable Molded Poly Tibia is intended to replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132. This device is a CoCr tibial plate with a removable molded UHMWPE tibial bearing that can be used with previously cleared modular Maxim tibial bearings.

AI/ML Overview

This document is a 510(k) summary for the Biomet, Inc. Maxim Removable Molded Poly Tibia Device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria. Therefore, the requested information about acceptance criteria and a study proving the device meets them cannot be fully provided from the given text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of acceptance criteria or reported device performance metrics in the way typically found in a clinical or performance study report (e.g., sensitivity, specificity, accuracy, mechanical failure rates, etc.).

Instead, the document details the intended use and potential risks of the device, and discusses its substantial equivalence to existing devices on the market. The FDA's letter further clarifies specific limitations and conditions for marketing the device.

Acceptance Criteria (Not explicitly stated in the document as such)	Reported Device Performance (Implied by substantial equivalence and intended use)
Functional Equivalence to legally marketed predicate devices	"In function and overall design the Maxim Removable Molded Poly Tibia Prosthesis is equivalent to other commercially available tibial components currently on the market."
Safety Profile comparable to existing knee joint replacement prostheses	Potential risks "are the same as with any joint replacement device." (A list of potential risks is provided: Reaction to bone cement, Fracture of components, Cardiovascular disorders, Implant loosening/migration, Soft tissue imbalance, Deformity of the joint, Delayed wound healing, Fracture of the cement, Bone fracture, Hematoma, Blood vessel damage, Nerve damage, Excessive wear, Infection, Metal sensitivity, Dislocation).
Material Composition for tibial plate and bearing	Device is a "CoCr tibial plate with a removable molded UHMWPE tibial bearing."
Specific Design Features	"Removable Molded Poly Tibia" intended to "replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132."
Cemented Use Only	Device is intended for "cemented use only." (This is a condition of clearance, not an "acceptance criterion" per se, but implies the device's performance relies on cemented fixation).
Minimum Polyethylene Thickness	The thinnest nominal 12mm insert has a minimum polyethylene thickness under the condyles of 6.6 mm. (This is a design specification, not a performance criterion).

2. Sample size used for the test set and the data provenance

The document does not report on a specific "test set" or a clinical study with associated sample sizes to demonstrate performance against acceptance criteria. The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than extensive new clinical performance data unless a new technological claim or significant difference warrants it.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no such test set or ground truth establishment is described in the provided document.

4. Adjudication method for the test set

Not applicable, as no such test set or adjudication process is described in the provided document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done or reported in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices assessing human-in-the-loop performance, not mechanical implants.

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

No, a "standalone algorithm only" performance study was not done or relevant. This device is a physical knee joint implant, not an algorithm.

7. The type of ground truth used

Not applicable, as the document focuses on substantial equivalence based on design, materials, and intended use, rather than a performance study requiring a "ground truth."

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI algorithm that requires a training set.

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

Not applicable.

Summary

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K98 4623

SUMMARY OF SAFETY AND EFFECTIVENESS

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

Maxim Removable Molded Poly Tibia Device:

Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis

Intended Use: Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant.

Device Description: The Maxim Removable Molded Poly Tibia is intended to replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132. This device is a CoCr tibial plate with a removable molded UHMWPE tibial bearing that can be used with previously cleared modular Maxim tibial bearings.

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

Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Dislocation
Substantial Equivalence: In function and overall design the Maxim Removable Molded Poly Tibia Prosthesis is equivalent to other commercially available tibial components currently on the market.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1999

Mr. Fred McClure Regulatory Specialist Biomet®, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K984623 Maxim Removable Molded Poly Tibia Requlatory Class: II Product Code: JWH Dated: February 16, 1999 Received: February 17, 1999

Dear Mr. McClure:

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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

The thinnest tibial insert available is the nominal 1. "12mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.6 mm.
1. This device may not be labeled or promoted for noncemented use.
1. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.

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Page 2 - Mr. Fred McClure

Any non-cemented fixation of this device is considered 4 . investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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. 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 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Page 3 - Mr. Fred McClure

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,

Turell C. Payne

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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Page 1 of 1

510 (k) Number (if known) : £ 984623

Maxim Removable Molded Poly Tibia Device Name:

Indications for use of knee joint replacement prostheses include: 1) painful and Indications For Use: disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.

Nunez// Lugano for Cia

Prescription Use
(Per 21 CFR 801.109)

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

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar 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.