The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.

The MUTARS® Proximal Femur System is intended for cemented use in total hip arthroplasty or hemiarthroplasty for the following indications:

Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of the prosthesis is generally only indicated in skeletally mature patients.

Device Description

The purpose of this Traditional 510(k) is to expand the MUTARS® Proximal Femur System with a line extension to the existing cementless femoral stems. The new stems are intended for cemented applications.

AI/ML Overview

This is a 510(k) summary for a medical device (MUTARS® Cemented Femoral Stems), not a study report detailing AI device performance. As such, most of the requested information about acceptance criteria, study design, and AI performance metrics is not applicable or available in this document.

However, I can extract the information relevant to the device's performance testing and the conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this document describes a traditional 510(k) for a medical implant and not an AI/software device, the "acceptance criteria" and "reported device performance" are related to mechanical and material properties rather than typical AI performance metrics like sensitivity, specificity, or AUC. The document states that testing was performed to assure substantial equivalence and demonstrate the subject devices perform as intended.

Acceptance Criteria (General Purpose)	Reported Device Performance
Assure substantial equivalence	Achieved
Perform as intended	Achieved
Meet ISO 7206-4 for Distal Stem Fatigue	Testing performed
Particle Analysis	Testing performed

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

The document states: "All testing was performed on test units representative of the finished device." It does not specify the exact sample size for the mechanical testing (e.g., number of stems tested for fatigue) or the data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. This is not an AI/diagnostic device that requires expert ground truth establishment for performance evaluation in the way a clinical study would. The performance is based on engineering and material testing.

4. Adjudication method for the test set

Not applicable. This is not an AI/diagnostic device requiring adjudication for ground truth.

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 a physical medical implant, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

For this type of device, the "ground truth" for performance would be established by:

Engineering specifications and standards: Adherence to established mechanical and material properties as defined by relevant industry standards (e.g., ISO 7206-4 for fatigue testing).
Predicate device characteristics: Comparison to the known performance and characteristics of the legally marketed predicate device (MUTARS® Proximal Femur System (K181778)) to establish substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary

{0}------------------------------------------------

October 16, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

implantcast, GmbH % Lindsay Kleinwaks Associate, Regulatory Affairs Mcra, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20005

Re: K200045

Trade/Device Name: MUTARS Cemented Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH, LZO, KWY Dated: September 16, 2020 Received: September 16, 2020

Dear Lindsay Kleinwaks:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa Vuniqi, M.S. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200045

Device Name MUTARS® Cemented Femoral Stems

Indications for Use (Describe)

The MUTARS® Proximal Femur System is intended for cemented use in total hip arthroplasty or hemiarthroplasty for the following indications:

Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of the prosthesis is generally only indicated in skeletally mature patients.

Type of Use (Select one or both, as applicable)	☑ Prescription Use (Part 21 CFR 201 Subpart D)☐ Over-The-Counter Use (21 CFR 201 Subpart C)	☑ Prescription Use (Part 21 CFR 201 Subpart D)	☐ Over-The-Counter Use (21 CFR 201 Subpart C)
☑ Prescription Use (Part 21 CFR 201 Subpart D)
☐ Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5. 510(K) SUMMARY

Manufacturer:	implantcast GmbHLueneburger Schanze 2621614 BuxtehudeGermany
Contact:	Ms. Juliane HöppnerPhone: +49 4161 744-135Fax: +49 4161 744-200j.hoeppner@implantcast.de
Prepared By:	Lindsay Kleinwaks, Ph.D.MCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5833lkleinwaks@mcra.com
Date Prepared:	January 8, 2019
Device Trade Name:	MUTARS® Cemented Femoral Stem
Device Class andCommon Name:	Class II, Femoral Stem
Classification:	21 CFR §888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis21 CFR §888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis – Class II
Product Codes:	MEH, LZO, KWY
Indications for Use:	The MUTARS® Proximal Femur Replacement System is amodular hip replacement system offering various components thatcan be combined to replace the hip joint and address major bonedefects with various options depending upon the size and locationof the defects of each patient.
	The MUTARS® Proximal Femur System is intended for cementedand uncemented use in total hip arthroplasty or hemiarthroplasty forthe following indications:
	- Proximal femur replacement in oncology cases whereradical resection and replacement of bone is required.- Limb salvage procedures including surgical intervention forsevere trauma, failed previous prosthesis, and/or oncologyindications, where radical resection and replacement of thebone is required.
	Use of the prosthesis is generally only indicated in skeletally maturepatients.
Device Description:	The purpose of this Traditional 510(k) is to expand the MUTARS®Proximal Femur System with a line extension to the existingcementless femoral stems. The new stems are intended forcemented applications.
Predicate Devices:	MUTARS® Proximal Femur System (K181778)
SubstantialEquivalence:	The MUTARS® Cemented Femoral Stems are substantiallyequivalent to the predicate device system, the MUTARS® ProximalFemur Replacement System with respect to intended use anddesign.
Performance Testing:	All necessary testing has been performed for the worst-caseMUTARS® Cemented Femoral Stems to assure substantialequivalence to its predicate and to demonstrate the subject devicesperform as intended. All testing was performed on test unitsrepresentative of the finished device. The following testing wasconducted to characterize the devices:- Distal Stem Fatigue Testing (ISO 7206-4)- Particle Analysis

{4}------------------------------------------------

{5}------------------------------------------------

Conclusions: The MUTARS® Cemented Femoral Stems possess the same intended use and technological characteristics as the predicate device. As such, the MUTARS® Cemented Femoral Stems are substantially equivalent for the intended use.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.