Xerxes Hip Stems, when used with cleared and compatible Signature Orthopaedics hip replacement components, are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
Inflammatory joint disease including rheumatoid arthritis
Correction of functional deformity including congenital hip dysplasia
Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement.
Xerxes Hip femoral stems are intended for cementless fixation only. The Xerxes Hip System is intended for use with Logical, World Acetabular System and Signature Orthopaedics' Femoral Heads.
Xerxes Hip when used with constrained liner components is indicated particularly for patients at high risk of hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Device Description

Xerxes™ Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Xerxes™ Hip Stem is an anatomical stem with a 5° anteversion neck and a 250 mm radius curvature on the stem body. The stem has three different surface and/or coating areas. The distal tip portion is colour anodised, polished, and rounded to aid in the insertion and avoiding distal interference. The remainder of the stem below its resection line is coated for cementless fixation. The middle portion of the stem is coated with a single layer of hydroxyapatite coating, as per ISO 13779-2 while the proximal portion is coated with an additional layer of titanium plasma spray as per ASTM F1580.

AI/ML Overview

This document describes a 510(k) premarket notification for the Xerxes Hip Stem, a medical device. It does not contain information about the acceptance criteria or a study proving that the device meets such criteria in the way one might expect for an AI/CADe device.

The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance data, rather than detailing a study that measures new performance metrics against specific acceptance thresholds for a novel device.

However, I can extract the information provided regarding the "performance data" in the context of demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for novel device performance. Instead, it lists non-clinical tests conducted to verify the performance of the Xerxes Hip Stem is adequate for anticipated in-vivo use and support substantial equivalence. The "performance" here refers to satisfying established standards or engineering expectations for hip stems, rather than a quantifiable diagnostic accuracy or similar metric for an AI device.

Test Conducted	Standard/Method Referenced	Reported Device Performance (Implied "Meets Criteria")
Range of Motion testing	ISO 21535	Adequate for anticipated in-vivo use
Stem and Neck Fatigue Finite Element Analysis	ASTM F2996	Adequate for anticipated in-vivo use
Stem and Neck Fatigue Testing	ISO 7206-4 and ISO 7206-6	Adequate for anticipated in-vivo use
Pyrogenicity and Endotoxin Testing	AAMI ST72	Adequate for anticipated in-vivo use

2. Sample Size for Test Set and Data Provenance
Not applicable. This device is a mechanical implant (hip stem), and the testing described is non-clinical performance and fatigue testing, not a study involving patient data or images.

3. Number of Experts and Qualifications for Ground Truth
Not applicable. Ground truth as typically defined for a diagnostic device or AI algorithm is not relevant for the non-clinical mechanical testing of a hip stem.

4. Adjudication Method
Not applicable. No adjudication method is mentioned, as this is non-clinical mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/CADe device, and no MRMC study was conducted.

6. Standalone Performance Study
The "Performance Data" section describes standalone non-clinical testing of the device's mechanical properties and safety (pyrogenicity/endotoxin). These tests are conducted on the device itself (or its components) without human intervention to assess its intrinsic performance against engineering standards. The phrase "standalone" as used in AI performance studies (algorithm only) doesn't directly apply here, but the tests are focused solely on the device's characteristics.

7. Type of Ground Truth Used
Not applicable. For mechanical tests, the "ground truth" is typically defined by the test standard itself (e.g., specific load cycles, deformation limits, material properties).

8. Sample Size for Training Set
Not applicable. This is not an AI/CADe device; therefore, no training set was used.

9. How Ground Truth for Training Set Was Established
Not applicable. This is not an AI/CADe device; therefore, no training set ground truth was established.

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

June 15, 2023

Xerxes Arthopedix LLC H Kurtis Biggs President 181 Eugenia Dr. Naples, Florida 34108

Re: K231109

Trade/Device Name: Xerxes Hip Stem 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, MEH, KWZ Dated: April 13, 2023 Received: April 19, 2023

Dear Dr. H Kurtis Biggs:

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.

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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 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 (QS) 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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K231109

Device Name Xerxes Hip Stem

Indications for Use (Describe)

Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
Inflammatorv joint disease including rheumatoid arthritis
Correction of functional deformity including congenital hip dysplasia
Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement.

Xerxes Hip femoral stems are intended for cementless fixation only. The Xerxes Hip System is intended for use with Logical, World Acetabular System and Signature Orthopaedics' Femoral Heads.

Xerxes Hip when used with constrained liner components is indicated particularly for patients at high risk of hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

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

Prescription Use (Part 21 CFR 801 Subpart D)	✔
Over-The-Counter Use (21 CFR 801 Subpart C)	□

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510(K) SUMMARY

Device Trade Name:	Xerxes Hip Stem
Common Name:	Cementless Hip Replacement Prosthesis
Contact:	Dr. H. Kurtis BiggsPresident, Xerxes Arthropedix LLC
Submitter:	Xerxes Arthropedix LLC181 Eugenia Dr., Naples, FL 34108Phone: 239-313-0543Fax: 239-262-5633
Date Prepared:	15 June 2023
Classification:	Class II as per 21 CFR 888.3353 Hip joint metal/ceramic/polymersemi-constrained cemented or nonporous uncemented prosthesisClass II as per 21 CFR 888.3310 Hip joint metal/polymerconstrained cemented or uncemented prosthesis
Product Codes:	LZO, MEH, KWZ
Predicate Devices:	Primary Predicate Medacta International's MiniMAX Stem (K170845 & K192352) Additional Predicate Device(s): Signature Orthopaedics' Spartan Hip Stem (K192883) Signature Orthopaedics' Everglade Hip Stem (K211505) Signature Orthopaedics' OriginTM Total Hip System (K121297) Signature Orthopaedics' Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner (K153131)

Device Description:

Indications for Use:

Xerxes M Hip Stems, when used with cleared and compatible Signature Orthopaedics hip replacement components, are intended to replace a hip joint where bone stock is sufficient to

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support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

. Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
Inflammatory joint disease including rheumatoid arthritis
Correction of functional deformity including congenital hip dysplasia
Traumatic injury involving the hip joint including traumatic arthritis or femoral head or . neck fracture
Failed previous hip surgery including internal fixation or joint fusion, reconstruction, . hemiarthroplasty, surface replacement, or total replacement

Xerxes™ Hip femoral stems are intended for cementless fixation only. The Xerxes™ Hip System is intended for use with Logical™, World™ Acetabular Systems and Signature Orthopaedics' Femoral Heads.

Xerxes™ Hip when used with constrained liner components is indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Summary of Technological Characteristics:

Hip arthroplasty is the technological principle for both the subject and the predicate devices. The subject and primary predicate devices are based on the same technological elements as listed below:

The subject device is intended for cementless fixation which is the same intended use ● as the MiniMAX Stem.
The indications for use of the subject device are the same as the MiniMAX Stem. ●
. The intended surgery sites of the subject device match the intended surgery sites of the MiniMAX Stem.
. The subject devices are manufactured from the same raw and coating materials as the MiniMAX Stem.
. The subject device has the same design features and size ranges as Medacta International's MiniMAX Stem.
. The subject device has the same 12/14 femoral head connection feature as the MiniMax Stem

The following are the technological differences between the subject device and the primary predicate devices:

The subject device has a smaller anteversion angle neck design than the MiniMAX ● Stem
Further comparison of the subject device and additional predicate devices was made and found that:
. The subject device has the same 12/14 trunnion geometry as the Spartan and Everglade Stems.
. The subject device has the same surface finish on the taper connection as the Spartan and Everglade Stems.
The subject device is compatible with the same femoral heads and associated acetabular components as the Spartan and Everglade Hip Stems.
. The subject device is manufactured and sterilised using the same methods as the Spartan and Everglade Stems.

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Performance Data:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Xerxes Hip Stem is adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:

. Range of Motion testing as per ISO 21535
Stem and Neck Fatigue FEA as per ASTM F2996 ●
Stem and Neck Fatigue Testing as per ISO 7206-4 and ISO 7206-6 .
. Pyrogenicity and Endotoxin Testing as per AAMI ST72

Conclusion:

Xerxes™ Stem is substantially equivalent to Medacta International's MiniMAX Stem (K170845 and K192352) since it has the same intended use, indications for use, material and similar design features. Non-clinical testing results support the substantial equivalence claim. Therefore, the subject devices are expected to perform adequately during clinical 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.