The Arcos Trochanteric Button is intended for use with the Arcos Modular Femoral Revision System, which is cleared only for uncemented use (K090757), as well as the Arcos Interlocking Stems, a line extension to the Arcos Modular Femoral Revision System, added by Special 510(k) K 100469, listed in the compatible component section.

Indications For Use:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed total hip arthroplasty.

The Arcos Modular Femoral Revision System Trochanteric Button hip components are singleuse implants, intended for uncemented applications.

Device Description

The Arcos Trochanteric Button is being added to the Arcos Modular Femoral Revision System, K090757, to expand surgical options beyond the claw when increased proximal stability is needed, especially when a greater trochanteric osteotomy has been performed. This assembly allows the greater trochanter to be compressed against the prosthesis or for reattaching the greater trochanter in cases where a trochanteric osteotomy has been performed. The Trochanteric Button comes in one size and is manufactured from Ti-6Al-4V. The design is very similar to the cleared Trochanteric Plate cleared for use with the Mallory-Head Modular Calcar System, K031693.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Arcos Modular Femoral Revision System Trochanteric Button. This device is an accessory for a hip prosthesis system. The acceptance criteria and supporting study are detailed for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, based on reduced stresses due to the smaller hole and larger contact area. (Performance is related to mechanical integrity and ability to fulfill surgical expectations, specifically for increased proximal stability or reattaching the greater trochanter).	Non-Clinical Testing: - Pull-Through Comparison (FEA): This analysis was performed. - Cross Section Analysis: This analysis was performed.The conclusion drawn from these analyses is that "Since the stresses are reduced on the new washer due to the smaller hole and larger contact area, the proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, thus meeting the acceptance criteria, indicating capability to fulfill surgical expectations."

Acceptance Criteria

Reported Device Performance

The proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, based on reduced stresses due to the smaller hole and larger contact area. (Performance is related to mechanical integrity and ability to fulfill surgical expectations, specifically for increased proximal stability or reattaching the greater trochanter).

Non-Clinical Testing: - Pull-Through Comparison (FEA): This analysis was performed. - Cross Section Analysis: This analysis was performed.The conclusion drawn from these analyses is that "Since the stresses are reduced on the new washer due to the smaller hole and larger contact area, the proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, thus meeting the acceptance criteria, indicating capability to fulfill surgical expectations."

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

Sample Size for Test Set: Not applicable. The study conducted was non-clinical (FEA and cross-section analysis) and did not involve a "test set" of patient data or physical samples in the way a clinical study would. It involved engineering analysis of the device design itself.
Data Provenance: Not applicable. As it was non-clinical engineering analysis, there is no country of origin or retrospective/prospective designation relevant for patient data.

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

Number of Experts: Not applicable. The "ground truth" in this context is based on engineering principles and comparison to a predicate device's established mechanical performance, not expert consensus on patient data.
Qualifications of Experts: Not specified, but can be inferred to be engineering professionals capable of Finite Element Analysis (FEA) and mechanical stress analysis, given the nature of the tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no clinical test set requiring adjudication. The evaluation was based on engineering analysis and comparison against the performance characteristics of a predicate device.

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

MRMC Comparative Effectiveness Study: No, this type of study was not conducted as this is a mechanical medical device (implant accessory), not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

Standalone Performance Study: Not applicable. This is not an AI algorithm. The performance was assessed through non-clinical engineering tests (FEA and cross-section analysis) of the device's mechanical properties.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for demonstrating substantial equivalence was the established mechanical performance and safety profile of the predicate device (Mallory-Head® Trochanter Plate) and the application of engineering principles (Finite Element Analysis, stress reduction theory). The objective was to show the new device performs "as well or better" than the predicate.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There was no "training set" in the context of an AI/machine learning model, as this is a mechanical device.

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

Ground Truth for Training Set Establishment: Not applicable. No training set was used.

Summary

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K130063 (Page 1 of 3)

APR 1 9 2013

CORP. MANUF

510(k) Summary

Preparation Date:

March 5, 2013

Becky Earl

Regulatory Specialist

Biomet Manufacturing Corp. Phone: (574) 372-1518 Fax: (574) 372-1683 becky.earl@biomet.com

Applicant/Sponsor:

Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 FDA Registration Number: 1825034

Contact Person:

Proprietary Name:

Arcos Modular Femoral Revision System Trochanteric Button

Common Name:

Trochanteric bolt washer; hip prosthesis accessory

Classification Code(s)/Name(s):

LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358)

LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888.3353)

KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (21 CFR 888.3310)

JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)

Matling Address PO Rox 587 Warsaw IN 46581-0587 Toll Free 800 348 9500 Office: 574 267 6639 Main Fax: 574,267,8137 unmat com

ino Address: st Rell Oriva Warsaw, IN 46582

ﺕ ﻳ

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KWY-Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or Uncemented (21 CFR 888.3390)

MAY-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Cemented, Osteophilic Finish (21 CFR 888.3353)

MEH-Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353)

JDG-Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360).

OOG-Prosthesis, hip, semi-constrained, metal/polymer + additive, porous uncemented (21 CFR 888.3358)

OOH-Hip, semi-constrained, cemented, metal/polymer + additive, cemented (21 CFR 888.3350)

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)

LWJ-prosthesis, hip, semi-constrained, metal/polymer, uncemented (888.3360)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

The predicate device is the Biomet Modular Femoral Revision Modular System (Arcos), K090757.

Device Description:

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Intended Use:

Indications For Use:

1. Noninflammatory 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 using other techniques.
1. Revision of previously failed total hip arthroplasty.

The Arcos Modular Femoral Revision System Trochanteric Button hip components are singleuse implants, intended for uncemented applications.

Summary of Technologies:

The Arcos Trochanteric Button is being added to the line of accessories for use with the Arcos Modular Femoral Revision System. The Arcos Trochanteric Button uses the same technology as the referenced previously cleared Trochanter Plate included in the Revision Mallory-Head Modular Calcar with and without HA, K031693, which served as a predicate for the Arcos Modular Femoral Revision System. The subject device is manufactured from the same material, conforming to the same standard, as the previously cleared Trochanter Plate.

Non-Clinical Testing:

· Pull-Through Comparison (FEA)
· Cross Section Analysis

Since the stresses are reduced on the new washer due to the smaller hole and larger contact area, the proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, thus meeting the acceptance criteria, indicating capability to fulfill surgical expectations.

Clinical Testing:

None provided as a basis for substantial equivalence.

Testing and analysis demonstrates that the modifications made to the Arcos Modular Femoral Revision System, by the addition of the Arcos Trochanteric Button, do not introduce any new risks of safety or efficacy.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Biomet Manufacturing Corporation % Ms. Becky Earl Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Letter dated: April 19, 2013

Re: K130063 Trade/Device Name: Arcos Modular Femoral Revision System Trochanteric Button Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWZ, JDI, KWY, MAY, MEH, JDG, OQG, OQH, OQI, PBI, LWJ Dated: March 22, 2013 Received: March 25, 2013

Dear Ms. Earl:

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

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Page 2 - Ms. Becky Earl

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 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/ResourcesforYou/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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

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); K130063

Device Name: Arcos Modular Femoral Revision System Trochanteric Button

Indications For Use:

1. Noninflammatory 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 using other techniques.
1. Revision of previously failed total hip arthroplasty.

The Arcos Modular Femoral Revision System Trochanteric Button hip components are single-use implants, intended for uncemented applications.

Prescription Use (Part 21 CFR 801 Subpart D)

ースアート (1) 【 ( ) 【 ( ) 【 ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( )

AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR 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)

Elizabeth & Erank -S

Division of Orthopedic Devices

Page 1 of 1

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.