MAK OSS KNEE FEMORAL COMPONENTS

• K Number: K083779
• Device Name: MAK OSS KNEE FEMORAL COMPONENTS
• Manufacturer: BIOMET MANUFACTURING CORP.
• Date Cleared: 2009-04-03 ( 105 days)
• Product Code: KRO
• Regulation Number: 888.3510
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K002757 , K051479 , K052685
• Predicate For: K131393

Intended Use

Biomet's OSS Knee System is intended for use in total knee replacement. Specific indications for these devices are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
2. Correction of varus, valgus or post traumatic deformity
3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies
5. Tumor resections
6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
7. Revision of previously failed total joint arthroplasty
8. Trauma
   These devices are to be used with bone cement

Device Description

There are two styles of MAK OSS Knee Femoral components, resurfacing and segmental. They have a plasma spray porous coating on the distal bone/implant interface surface and the articular surfaces have a color buff surface and two holes in the posterior condyles accommodate the femoral bushings and axle that connect the femoral component to the tibial component to create a hinged knee.
A polyethylene hyperextension bumper component fits into a pocket between the femoral condyles at the time of surgery. The bumper limits the amount of extension allowed by the implant.

AI/ML Overview

This 510(k) premarket notification for the "MAK OSS Knee Femoral Components" indicates that it is a medical device for total knee replacement. The review explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means that no clinical study was conducted for this device to prove it meets specific acceptance criteria based on human or AI performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details. The submission relies solely on non-clinical laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an explanation of what can and cannot be provided based on the given text:

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

• Cannot be provided. The document states "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This refers to mechanical or material testing, not performance against clinical acceptance criteria. No specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) are mentioned for human or AI performance.

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

• Cannot be provided. No clinical test set was used for human or AI performance evaluation.

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):

• Cannot be provided. No clinical test set requiring expert ground truth was utilized.

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

• Cannot be provided. No clinical test set requiring adjudication was utilized.

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:

• Cannot be provided. No MRMC study was conducted, as no clinical testing was performed. The device is a physical knee implant, not an AI-assisted diagnostic tool.

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

• Cannot be provided. This device is a physical knee femoral component, not an algorithm, so standalone algorithm performance is not applicable.

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

• Cannot be provided. No clinical ground truth was established as no clinical testing was performed.

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm was used, as this is a physical medical device.

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

• Cannot be provided. Not applicable as no training set for an algorithm was used.

Summary

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Ko83729

Image /page/0/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized, blocky font, with a registered trademark symbol to the right of the "T". Below the logo is the text "MANUFACTURING CORP." in a simpler, sans-serif font.

510(k) Summary

APR - 3 2009

Preparation Date:	November 26, 2008
Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587Establishment Registration Number: 1825034
Contact Person:	Patricia Sandborn BeresSenior Regulatory Specialist
Proprietary Name:	MAK OSS Knee Femoral Components
Common Name:	Total Knee Replacement
Classification Name:	Knee joint femoraltibial metal/polymer constrained cementedprosthesis (21 CFR 888.3510)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K002757	Oncology Salvage System
K051479	RS (Reduced Size) OSS (Orthopedic Salvage System) Component
K052685	Orthopedic Salvage System – OSS

Device Description:

There are two styles of MAK OSS Knee Femoral components, resurfacing and segmental. They have a plasma spray porous coating on the distal bone/implant interface surface and the articular surfaces have a color buff surface and two holes in the posterior condyles accommodate the femoral bushings and axle that connect the femoral component to the tibial component to create a hinged knee.

A polyethylene hyperextension bumper component fits into a pocket between the femoral condyles at the time of surgery. The bumper limits the amount of extension allowed by the implant.

P.O. Box 587 Warsaw. IN 46581-0581 Toll Free: 800 348 9500 Office: 574 267 6630 Main Fax: [phone] www.biomet.com

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

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Intended Use:

Biomet's OSS Knee System is intended for use in total knee replacement. Specific indications for these devices are:

• 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
• 2. Correction of varus, valgus or post traumatic deformity
• 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
• 4. Ligament deficiencies
• 5. Tumor resections
• 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanaqeable using other techniques
• 7. Revision of previously failed total joint arthroplasty
• 8. Trauma

These devices are to be used with bone cement

Summary of Technologies:

The MAK OSS Knee Femoral Components have the same technological characteristics as the predicates listed above.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.

Public Health Service

APR - 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K083779

Trade/Device Name: MAK OSS Knee Femoral Components Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: December 17, 2008 Received: January 5, 2009

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 to 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 may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Aubrey Buchman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ___

Device Name: MAK OSS Knee Femoral Components

Indications For Use:

Biomet's OSS Knee System is intended for use in total knee replacement. Specific indications for these devices are:

K083779

• 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
• 2. Correction of varus, valgus or post traumatic deformity
• 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
• 4. Ligament deficiencies
• 5. Tumor resections
• 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
• 7. Revision of previously failed total joint arthroplasty
• 8. Trauma

These devices are to be used with bone cement

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ohabau Buelin for mom

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K083779

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.