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 this prosthesis is generally only indicated in skeletally mature patients.

Device Description

The purpose of this Traditional 510(k) is to expand the MUTARS® Cemented Femoral Stems and MUTARS® Proximal Femur Replacement System with a line extension to the existing stems. The new stems are available with longer lengths (160 and 200mm).

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically the MUTARS® femoral stem cemented 160 mm and 200 mm. Such notifications focus on demonstrating "substantial equivalence" to a legally marketed predicate device rather than establishing new acceptance criteria and proving performance against them in the same way one might for a novel device or software.

In this context, the "acceptance criteria" for the new device are implicitly that it performs comparably or acceptably to the predicate device, as demonstrated through adherence to relevant standards and performance testing.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance (Fatigue Strength): The device should withstand anticipated physiological loads without failure, demonstrated by meeting or exceeding the requirements of ISO 7206-4 for distal stem fatigue testing.	"All necessary testing has been performed for the worst-case MUTARS® femoral stem cemented 160 mm and 200 mm to assure substantial equivalence to the predicates and to demonstrate the subject devices perform as intended.""- Distal Stem Fatigue Testing (ISO 7206-4)""All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable."
Biocompatibility: Materials should be biocompatible and not elicit adverse biological responses.	While not explicitly detailed in the provided snippets, a 510(k) submission for an implantable device would typically include or reference biocompatibility testing to relevant ISO standards (e.g., ISO 10993 series). The statement "All necessary testing has been performed" implies this was addressed.
Material Properties: The materials used in the device should meet specified mechanical and chemical properties.	Not explicitly detailed in the provided snippets, but implied by the "All necessary testing" statement and comparison to the predicate device.
Design Equivalence/Similarity: The design features should be comparable to the predicate device for the intended use.	"The MUTARS® femoral stem cemented 160 mm and 200 mm subject to this submission possess the same intended use and technological characteristics as the predicate device system components."
Dimensional Specifications: The device dimensions (e.g., length) should meet manufacturing specifications and be within the expected range for the intended application (extension to 160mm and 200mm lengths).	The submission is for a "line extension to the existing stems" with "new stems... available with longer lengths (160 and 200mm)." This implies the dimensional specifications for these new lengths are defined and were adhered to. The testing of "worst-case" further supports this.
Manufacturing Quality: The device should be manufactured under a Quality System (QS) Regulation (21 CFR Part 820).	The FDA letter explicitly states, "Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820)..." and references design controls, nonconforming product, and corrective/preventive action. This is a regulatory requirement for acceptance of the device into the market.

The crucial phrase indicating acceptance criteria were met is: "All performance testing conducted... met the predetermined acceptance criteria or were otherwise considered acceptable."

Regarding the study that proves the device meets the acceptance criteria:

The document describes performance testing conducted on the device.

Type of Study: This was a bench testing study, specifically focused on Distal Stem Fatigue Testing (ISO 7206-4). This standard is designed to assess the endurance of femoral components of hip prostheses under simulated physiological loading conditions.
Proof of Meeting Criteria: The conclusion states that "All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable." This directly confirms the device performed as required by the established standard and internal criteria.

The remaining sections are not applicable to the provided document, as this is a mechanical medical device (femoral stem for hip replacement) and not an AI/software device. Therefore, questions related to sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not relevant to this 510(k) submission for a physical implant.

Specifically:

Sample size used for the test set and the data provenance: Not applicable. For mechanical testing like fatigue, the sample size is determined by the testing standard (e.g., ISO 7206-4) and statistical requirements for demonstrating meeting performance thresholds. The data provenance is from the specific test laboratory where the bench tests were conducted.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth in this context refers to engineering specifications and performance standards, not diagnostic interpretations by experts.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable as this is not an AI/software imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: For mechanical devices, the "ground truth" is defined by established engineering principles, material science, and international performance standards (like ISO 7206-4).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

October 30, 2024

Implantcast, GmbH % Hannah Irwin Director, Regulatory Affairs MCRA, LLC 803 7th Street NW, Floor 3 Washington, District of Columbia 20001

Re: K240391

Trade/Device Name: MUTARS® femoral stem cemented 160 mm and 200 mm 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: LZO, KWY

Dear Hannah Irwin:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 24, 2024. Specifically, FDA is updating this SE Letter to include the additional product code KWY as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Limin Sun, Ph.D., OHT6: Office of Orthopedic Devices, at 301-796-7056 or Limin.Sun(@fda.hhs.gov.

Sincerely,

Limin Sun -S

Limin Sun, Ph.D. 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

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 24, 2024

Implantcast, GmbH % Hannah Irwin Director, Regulatory Affairs MCRA, LLC 803 7th Street NW, Floor 3 Washington, District of Columbia 20001

Re: K240391

Trade/Device Name: MUTARS® femoral stem cemented 160 mm and 200 mm 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: LZO Dated: September 26, 2024 Received: September 25, 2024

Dear Hannah Irwin:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Limin Sun -S

Enclosure

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Indications for Use

510(k) Number (if known) K240391

Device Name

MUTARS® femoral stem cemented 160 mm and 200 mm

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 this prosthesis is generally only indicated in skeletally mature patients.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:	Ms. Hannah IrwinMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5820hirwin@mcra.com
Date Prepared:	October 22, 2024
Device Trade Name:	MUTARS® femoral stem cemented 160 mm and 200 mm
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
Product Codes:	LZO, KWY
Indications for Use:	The indications for use for the proposed MUTARS® femoralstem cemented 160 mm and 200 mm are as follows:The MUTARS® Proximal Femur Replacement Systemis a modular hip replacement system offering variouscomponents that can be combined to replace the hip jointand address major bone defects with various optionsdepending upon the size and location of the defects ofeach patient.
	The MUTARS® Proximal Femur System is intended forcemented and uncemented use in total hip arthroplasty orhemiarthroplasty for the following indications:
	• Proximal femur replacement in oncology caseswhere radical resection and replacement of boneis required.• Limb salvage procedures including surgicalintervention for severe trauma, failed previousprosthesis, and/or oncology indications, whereradical resection and replacement of the bone isrequired.
	Use of this prosthesis is generally only indicated inskeletally mature patients.
Device Description:	The purpose of this Traditional 510(k) is to expand theMUTARS® Cemented Femoral Stems and MUTARS®Proximal Femur Replacement System with a line extension tothe existing stems. The new stems are available with longerlengths (160 and 200mm).
Primary PredicateDevice:	MUTARS® Cemented Femoral Stems (K200045)
Additional PredicateDevice:	MUTARS® Proximal Femur Replacement System(K181778)
SubstantialEquivalence:	The MUTARS® femoral stem cemented 160 mm and 200mm is substantially equivalent to the hip stems of the legallymarketed predicate device systems, the implantcastMUTARS Cemented Femoral Stems and MUTARS®Proximal Femur Replacement System with respect tointended use and design.
Performance Testing:	All necessary testing has been performed for the worst-caseMUTARS® femoral stem cemented 160 mm and 200 mm toassure substantial equivalence to the predicates and todemonstrate the subject devices perform as intended. Alltesting was performed on test units representative of thefinished device.
	The following testing was conducted to characterize thedevice:

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. Distal Stem Fatigue Testing (ISO 7206-4)
Conclusions: The MUTARS® femoral stem cemented 160 mm and 200 mm subject to this submission possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the MUTARS® femoral stem cemented 160 mm and 200 mm is substantially equivalent to the predicate devices 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.