RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS

• K Number: K051479
• Device Name: RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
• Manufacturer: BIOMET MANUFACTURING, INC.
• Date Cleared: 2005-08-10 ( 68 days)
• Product Code: KRO
• Regulation Number: 888.3510
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K002757 , K021260
• Predicate For: K083779 , K141331

Intended Use

Indications for Use:

• 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 or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
• Ligament deficiencies. 4.
• 5. Tumor resections.
• Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with 6. head involvement, unmanageable using other techniques.
• 7. Revision of previously failed total joint arthroplasty.
• 8. Trauma.
     The RS OSS Additional Components are intended for cemented use only.

Device Description

The RS OSS Additional Components are a series of components including distal femoral resurfacing components in 3cm resection lengths and distal femoral segmental components with either modular or elliptical bone interface surfaces in 7cm and 8.5cm resection lengths. The tibial tray components are non-modular in design with either short stems. The Proximal Tibial Sleeves have a modular design that utilizes either the short or long stem tibial travs to provide 3cm. 7cm or 9cm of resection height. The resection tibial tray provides a non-modular 9cm resection height. The tibial augments are either 10mm or 20mm augment sizes. The 20mm augments are side specific. The 15° tibial bearings have been included and the extension bumper design has been modified. These components are intended to expand the available options for the Reduced Size Orthopedic Salvage System.

AI/ML Overview

The provided document is a 510(k) summary for the RS (Reduced Size) OSS (Orthopedic Salvage System) Additional Components. This document describes a medical device, specifically components for a joint replacement system (hip, knee, tibia, or total femur), and aims to demonstrate its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the requested information based only on the provided text:

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

Acceptance Criteria	Reported Device Performance
Mechanical Equivalence to Predicate Devices (Implicit: The new components should perform mechanically similar to the predicate devices and meet established standards.)	"Mechanical testing and engineering justification demonstrate that the RS OSS Additional Components are substantially equivalent to the predicate components."
Material Equivalence to Predicate Devices (Implicit: Materials should be the same as or equivalent to predicate devices.)	"The RS OSS Additional Components are made from the same materials conforming to the same standards..."
Manufacturing, Packaging, and Sterilization Process Equivalence to Predicate Devices (Implicit: Processes should be the same as or equivalent to predicate devices.)	"...and utilize the same manufacturing, packaging and sterilization processes as the predicate devices."

Explanation: The acceptance criteria for this type of 510(k) submission (a modification or expansion of an existing system) are largely based on demonstrating substantial equivalence to existing legally marketed predicate devices. This means showing that the new components perform at least as well as, and are as safe and effective as, the predicates. The "reported device performance" directly addresses this by stating that mechanical testing and engineering justification confirmed equivalence in critical areas.

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

The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence to the predicate devices."

Therefore:

• Sample size for the test set: Not applicable, as no clinical testing was performed.
• Data provenance: Not applicable. The "testing" referred to is non-clinical (mechanical and engineering).

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

Not applicable. As noted above, no clinical testing, and therefore no "ground truth" established by experts in a clinical study context, was deemed necessary for this 510(k) submission. The equivalence was established through non-clinical means.

4. Adjudication method for the test set

Not applicable, as no clinical testing with a test set requiring adjudication was performed.

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

Not applicable. This device is an orthopedic implant system, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is an orthopedic implant system, not an algorithm, and does not involve AI or human-in-the-loop performance in that context.

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

Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this device's acceptance is found in its demonstrated substantial equivalence to predicate devices through:

• Conformity to the same standards for materials.
• Utilization of the same manufacturing, packaging, and sterilization processes.
• Mechanical testing and engineering justification demonstrating equivalent performance.

This implicitly refers to established engineering and material science principles, and performance characteristics derived from testing against industry standards, rather than clinical outcomes or pathology.

8. The sample size for the training set

Not applicable. There is no "training set" mentioned or implied, as this is a physical medical device submission, not an AI/machine learning application.

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

Not applicable, as there is no training set.

Summary

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K051479$\rho^{1/2}$

AUG 1 0 2005

510(k) Summary

Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Gary BakerBiomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587Phone: [phone]FAX: [phone]
Proprietary Name:	RS (Reduced Size) OSS (Orthopedic Salvage System)Additional Components
Common Name:	Orthopedic Salvage Hip, Knee, Tibia, or Total Femur
Classification Name:	Prosthesis, Knee Femorotibial, Constrained, Cemented, Metal/Polyme
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Oncology Salvage System - K002757 (Biomet Inc.) Reduced Size Oncology System - K021260 (Biomet Inc.)

Device Description: The RS OSS Additional Components are a series of components including distal femoral resurfacing components in 3cm resection lengths and distal femoral segmental components with either modular or elliptical bone interface surfaces in 7cm and 8.5cm resection lengths. The tibial tray components are non-modular in design with either short stems. The Proximal Tibial Sleeves have a modular design that utilizes either the short or long stem tibial travs to provide 3cm. 7cm or 9cm of resection height. The resection tibial tray provides a non-modular 9cm resection height. The tibial augments are either 10mm or 20mm augment sizes. The 20mm augments are side specific. The 15° tibial bearings have been included and the extension bumper design has been modified. These components are intended to expand the available options for the Reduced Size Orthopedic Salvage System.

Intended Use:

Indications for Use:

• Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid 1. arthritis, or traumatic arthritis.
• 2. Correction of varus, valgus, or post traumatic deformity.
• 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
• Ligament deficiencies. 4.
• 5. Tumor resections.

MAHING ADDRESS PO Box 58" Warsaw, IN 16581 0587

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Supprise ADDRESS E. Bell Drives
Warsaw, IN -16-38.3 SHIPPING ADDRESS Warsaw. IN 16582

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EAN 574.36 181 57

E MAH. [e-mail]

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• Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with 6. head involvement, unmanageable using other techniques.
• 7. Revision of previously failed total joint arthroplasty.
• 8. Trauma.

The RS OSS Additional Components are intended for cemented use only.

Summary of Technologies: The RS OSS Additional Components are made from the same materials conforming to the same standards and utilize the same manufacturing, packaging and sterilization processes as the predicate devices.

Non-Clinical Testing: Mechanical testing and engineering justification demonstrate that the RS OSS Additional Components are substantially equivalent to the predicate components.

Clinical Testing: Clinical testing was not necessary to determine substantial equivalence to the predicate devices.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2005

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K051479

Trade/Device Name: RS (Reduced Size) OSS (Orthopedic Salvage System) Components Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: July 21, 2005 Received: July 22, 2005

Dear Mr. Baker:

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 - Mr. Gary Baker

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

A. Hypt. Rurke

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

Enclosure

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Page 1 of 1

Statement of Indications For Use

510(k) Number (IF KNOWN): _ K o S 147 S

Device Name: RS(Reduced Size) OSS (Orthopedic Salvage System) Components

Indications for Use:

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

The RS OSS Components are intended for cemented use only.

Prescription Use _ X (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Per 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)

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

510(k) Number K051479

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.