Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are:

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
Correction of varus, valgus or post-traumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Ligament deficiencies.
Tumor resections.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
Revision of previously failed total joint arthroplasty.
Trauma.

These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).

*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.

When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:

Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Tumor resections.
Revision of previously failed total joint arthroplasty.
Trauma.

Device Description

The Orthopedic Salvage System is a system of modular components that are intended to be used for difficult revision surgeries or limb salvage procedures. The components can replace any portion of, or the total femur and/or the knee and proximal tibia.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: Orthopedic Salvage System (OSS) with modified male tapers (roller hardened and machined taper).

The manufacturer conducted non-clinical testing to demonstrate that the modified tapers perform equivalently or better than the predicate device's tapers. Clinical testing was not required.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Cantilever Fatigue Test	Met acceptance criteria (explicitly stated)	Roller hardened tapers were stronger in cantilever fatigue than the predicate tapers.
Compressive Fatigue Test	Met acceptance criteria (explicitly stated)	Compressive fatigue strength of rollercoaster hardened tapers was equivalent to or greater than the predicate tapers.
Static Axial Separation Test	Met acceptance criteria (explicitly stated)	Pull-off strength of rollercoaster hardened tapers was equivalent to or greater than the predicate tapers.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of test articles) used for each non-clinical test (Cantilever Fatigue, Compressive Fatigue, Static Axial Separation).

The data provenance is from non-clinical laboratory testing conducted by Biomet Manufacturing Corp. (the applicant/sponsor). No country of origin is explicitly stated for the testing, but the company is based in Warsaw, Indiana, USA. The testing is inherently prospective as it evaluates new modifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this device (mechanical performance) is established through objective engineering measurements in non-clinical laboratory tests, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" for mechanical testing is based on engineered measurements and comparisons to predefined acceptance criteria, not human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This is a medical device (orthopedic implant) where performance is evaluated through mechanical testing, not through human interpretation of medical images. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence of the design modifications proposed to the cleared predicate devices."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical orthopedic implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established engineering standards and mechanical test results. The performance of the modified device (roller hardened tapers) was compared against the performance of predicate device tapers. The acceptance criteria for these tests serve as the ground truth benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with a thick outline. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black and the background is white.

K12350 (pg 1/3)

FEB 2 7 2013

510(k) Summary

Preparation Date:

23 October, 2012

Applicant/Sponsor: Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46582 FDA Registration #: 1825034

Contact Person:

Gary Baker Sr. Regulatory Specialist 56 East Bell Drive Warsaw, IN 46582 574-267-6639 Ext. 1568 574-371-1027 gary.baker@biomet.com

Proprietary Name:

· Orthopedic Salvage System (OSS)

Constrained knee Common Name:

Classification Code(s)/Name(s): JDI, KRO

888.3350 (JDI) - Hip joint metal/polymer semi-constrained cemented prosthesis.

888.3510 (KRO) - Knee joint femorotibial metal/polymer constrained cemented prosthesis

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K002757 - Oncology Salvage System (Biomet)

Device Description:

Intended Use:

The Orthopedic Salvage System components are intended for cemented use only unless used in a proximal femoral replacement application.

Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
www.biomet.com

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Indications For Use:

Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
1. Correction of varus, valgus or post-traumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
1. Ligament deficiencies.
1. Tumor resections.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
1. Revision of previously failed total joint arthroplasty.
1. Trauma.

These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).

*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.

When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:

1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
1. Tumor resections.
1. Revision of previously failed total joint arthroplasty.
1. Trauma.

Summarv of Technologies:

The modifications proposed within this submission include expanding the product line and modifying the male tapers from a machined taper to a roller hardened and machined taper.

Non-Clinical Testing:

Cantilever Fatigue testing was conducted to evaluate the taper cantilever fatigue strength and compare the results with the cantilever fatigue strength of the predicate tapers. Results determined that the roller hardened tapers were stronger in cantilever fatigue than the predicate tapers. The acceptance criteria were met.

Compressive Fatigue testing was conducted to evaluate the taper compressive fatigue strength and compare the results with the compressive fatigue strength of the predicate tapers. Results determined that the compressive fatigue strength of the roller hardened tapers was equivalent to or greater than the compressive fatigue strength of the predicate tapers. The acceptance criteria were met.

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K123501 (pg 3/3)

Static Axial Separation testing was conducted to evaluate the pull-off strength of the taper junction and compare the results with the pull-off strength of the taper junction of the predicate tapers. Results determined that the pull-off strength of the roller hardened tapers was equivalent to or greater than the pull-off strength of the predicate tapers. The acceptance criteria were met.

Clinical Testing:

Clinical testing was not required to demonstrate substantial equivalence of the design modifications proposed to the cleared predicate devices.

All trademarks are property of Biomet, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2013

Biomet Manufacturing Corp. % Mr. Gary Baker Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582

Re: K123501

Trade/Device Name: Orthopedic Salvage System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, KRO Dated: January 11, 2013 Received: January 28, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Gary Baker

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ErinI.D.Keith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _______K123501

Device Name: Orthopedic Salvage System

Indications for Use:

Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
1. Correction of varus, valgus or post-traumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
1. Ligament deficiencies.
1. Tumor resections.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femirr with head involvement, unmanageable by other techniques. *
1. Revision of previously failed total joint arthroplasty.
1. Trauma.

These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).

*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.

When components of the Orthopedie Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, there intended for uncemented application and indicated for:

Correction or revision of unsucessful osteotomy, arthrodesis, or previous joint replacement.

1. Tumor resections.
1. Revision of previously fuiled total joint arthroplasty.
1. Traumu

Prescription Use _ YES __ AND/OR Over-The-Counter Use NO NO ____(Part (21 CFR 807 Subpart C) 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabethi i Mrank -S

Division of Orthopedic Devices

Page 1 of 1

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.