1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
1. Revision procedures where other treatment or devices have failed.

The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.

Device Description

The Sirius femoral stem is a highly polished, double-tapered, cemented stem designed to reduce hip pain for patients and restore ioint biomechanics and stability. The short stem is designed to fit a broad range of patient anatomies for primary or revision cases. The features include a collarless, highly polished, doubletaper design, with a rectangular proximal geometry. The distal portion of the stem has a progressive diminishing cross-section. Each stem is packed with a winged and wingless centralizer, made of polymethylmethacrylate (PMMA), designed to help create a uniform mantle.. The size ranges are within the ranges of legally marketed predicates. The Sirius stem is made from Co-Cr-Mo, ASTM F799.

AI/ML Overview

This document describes the Biomet Manufacturing Corp.'s Sirius Femoral Hip Stem, a medical device, and the non-clinical testing performed to establish its substantial equivalence to predicate devices. No clinical testing was conducted.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sirius Femoral Hip Stem are implied by its demonstration of "substantial equivalence" to legally marketed predicate devices through non-clinical testing. The performance demonstrated that the device is "as safe, as effective, and performs as well as or better than the predicate devices."

Acceptance Criteria (Implied from Substantial Equivalence to Predicates)	Reported Device Performance (as demonstrated by non-clinical testing)
Mechanical and physiological performance consistent with predicate devices for:
Distal Stem fatigue strength	Met or exceeded
Proximal Stem fatigue strength	Met or exceeded
Cobalt Chrome Modular Head Pull-off from a Type 1 Reduced Taper strength	Met or exceeded
Range of Motion	Consistent with
Comparison/Justification for Modular Connections	Met or exceeded
Fretting and Corrosion resistance	Met or exceeded
Material composition (Co-Cr-Mo, ASTM F799)	Confirmed to be Co-Cr-Mo, ASTM F799
Centralizer material (Polymethylmethacrylate (PMMA))	Confirmed to be PMMA
Taper-slip principle effectiveness	Demonstrated to be effective
Rotational stability	Demonstrated to be effective

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

This information is not provided in the document. The document refers to "nonclinical performance testing of the worst-case stem" and standardized tests (ISO 7206-4:2010, ASTM F2068-09, ISO 7206-6:1992, ISO 7206-10:2003, ISO 21535:2009) but does not specify the number of samples or data provenance (e.g., country of origin, retrospective or prospective) for these non-clinical tests.

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

This information is not applicable as the study described is non-clinical (mechanical testing) and does not involve human expert evaluation for establishing ground truth in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is non-clinical and does not involve human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The document describes a medical device (femoral hip stem) and its non-clinical testing for substantial equivalence, not an AI or imaging-based device requiring human reader studies.

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

This information is not applicable as the device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was established by international and industry standards and guidance documents (e.g., ISO 7206 series, ASTM F2068-09, "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses"). The performance of the Sirius Femoral Hip Stem was compared against the requirements and performance characteristics outlined in these standards and the known performance of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not a learning algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with a geometric design. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black on a white background.

510(k) Summary

Preparation Date:	March 6, 2013	AUG 3 0 2013
Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587Establishment Registration Number: 1825034
Contact Person:	Becky EarlRegulatory Specialist
Proprietary Name:	Sirius Femoral Stem
Common Name:	Cemented modular hip prosthesis
Classification Name:	JDI— Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350).LZO—Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353).KWZ— Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310).MEH—Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353).LPH—Hip joint metal/polymer/metal semi-constrained porous-coated, uncemented prosthesis (21 CFR 888.3358).KWY—Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390).JDG—Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360).LZY—Hip joint (hemi-hip) acetabular metal cemented prosthesis (21 CFR 888.3370).OQG—Prosthesis, hip, semi-constrained, metal/polymer + additive, porous uncemented (888.3358)OQH—Hip, semi-constrained, cemented, metal/polymer + additive, cemented (21 CFR 888.3350)
Mailing Address:	P.O. Box 587Warsaw, IN 46581-0587Toll Free: 800.348.9500Office: 574.267.6639Main Fax: 574.267.8137
Shipping Address:	56 E. Bell DriveWarsaw, IN 46582

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OOI-Hip. semi-constrained. cemented. metal/ceramic/polymer + additive. porous uncemented (21 CFR 888.3353)

PBI-Prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive (21 CFR 888.3310)

KWL-Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Prosthesis (21 CFR 888.3360)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Generation 4 (Gen 4) Polished Femoral Hip System with Proximal Cement Spacer -Biomet-(K052639)

Collarless Polished Taper (CPT) Stem -Zimmer-(K960658)

Device Description:

Intended Use:

Components are intended for cemented use and may be used in partial and total hip arthroplasties.

Indications for Use:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.
Rheumatoid arthritis. 2.
Correction of functional deformity. 3.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4. head involvement, unmanageable by other techniques.
ട. Revision procedures where other treatment or devices have failed.

The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.

Summary of Technologies:

The technological characteristics are the predicates identified in the Legally Marketed Devices to which substantial equivalence is claimed. The design is based on the taper-slip principle: the taper subsides at the stem/cement interface, and the double-taper becomes solidly engaged in the cement mantle. The geometry favors rotational stability to help minimize loosening. The stem is made of Co-Cr-Mo, ASTM F799, as are the predicates, and the centralizers are made of polymethylmethacrylate (PMMA). The Sirius stem is available in seven body sizes with numerous offsets to enable proper sizing and the Type 1 taper enables the choice of numerous modular heads. The Sirius stem features a short length, but the shortest stem in the Sirius system fits within the predicate range of sizes.

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Non-Clinical Testing:

Nonclinical performance testing was performed to support substantial equivalence. The testing included Distal and Proximal Stem fatigue testing of the worst-case stem, consistent with the "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses", ISO 7206-4:2010, ASTM F2068-09 and ISO 7206-6:1992, Cobalt Chrome Modular Head Pull-off from a Type 1 Reduced Taper, as outlined in ISO 7206-10:2003, as well as a Range of Motion analysis consistent with ISO 21535:2009 and a Comparison/ Justification for Modular Connections, Fretting and Corrosion Testing.

Clinical Testing:

None provided as a basis for substantial equivalence.

The results of non-clinical testing demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure embracing a circle. The words "HUMAN SERVICES-USA" are written around the top half of the circle, and "DEPARTMENT OF" are written around the bottom half of the circle.

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

August 30, 2013

Ms. Becky Earl Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581

Re: K130610

Trade/Device Name: Sirius Femoral Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, LZO, KWZ, MEH, LPH, KWY, JDG, LZY, OQG, OQH, OQI, PBI, K WL Dated: May 31, 2013 Received: June 5, 2013

Dear Ms. Earl:

We have reviewed vour 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

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Page 2 -- Ms. Becky Earl

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Erin I. Keith

For

Mark 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): K130610

Device Name: Sirius Femoral Hip Stem

Indications For Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
1. Revision procedures where other treatment or devices have failed.

The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.

Prescription Use_ × (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ NO (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Page 1 of 1

Division of Orthopedic Devices

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.