Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

Device Description

The purpose of this Traditional 510(k) is to notify the FDA of our intent to market the Smith & Nephew CATALYSTEM Femoral Stems. The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary hip arthroplasty in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options. The CATALYSTEM Femoral Stems are non-cemented femoral hip stems manufactured from forged titanium alloy and feature a CP-Ti and HA coating.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

AI/ML Overview

This document is a 510(k) summary for the CATALYSTEM Femoral Stems. It describes a medical device, specifically hip joint components, and outlines the testing and analyses conducted to demonstrate its substantial equivalence to previously marketed devices. This type of submission does not typically involve AI/ML components or studies on diagnostic performance, but rather focuses on mechanical integrity, materials, and biocompatibility.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable in the context of this device and submission type. The device is a physical implant, not a diagnostic software or AI product.

However, I can provide the acceptance criteria and a summary of the studies that prove the device meets these criteria based on the non-clinical testing performed, as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria	Reported Device Performance
Distal Fatigue Testing (ISO 7206-4, ASTM F2996-20)	Meets or exceeds the fatigue strength requirements for its class (implied by meeting standards)	Device met the required acceptance criteria as per the standards.
Neck Fatigue Testing (ISO 7206-6, ASTM F2996-20)	Meets or exceeds the fatigue strength requirements for its class (implied by meeting standards)	Device met the required acceptance criteria as per the standards.
Range of Motion (ROM) Evaluation (ISO 21535)	Demonstrated acceptable range of motion performance (implied by meeting standards)	Device demonstrated acceptable range of motion performance.
Fretting and Corrosion Performance Rationale	Acceptable fretting and corrosion characteristics (established by rationale)	Performance deemed acceptable based on engineering rationale.
Femoral Head Disassembly Performance Rationale	Acceptable disassembly characteristics (established by rationale)	Performance deemed acceptable based on engineering rationale.
HA Chemical Characterization (ASTM F1980-21, ISO 13779-2, ISO 13779-3)	Chemical composition meets specified requirements for HA coating.	HA coating's chemical characterization met specified requirements.
HA Static Tensile Attachment Strength Testing (ASTM F1147-05, ISO 13779-4)	Meets or exceeds specified tensile attachment strength for HA coating.	HA coating met or exceeded the required tensile attachment strength.
HA Static Shear Attachment Testing (ASTM F1044-05R17e01)	Meets or exceeds specified shear attachment strength for HA coating.	HA coating met or exceeded the required shear attachment strength.
HA Shear Fatigue Strength Testing (ASTM F1044-05R17e01, ASTM F1160-14)	Meets or exceeds specified shear fatigue strength for HA coating.	HA coating met or exceeded the required shear fatigue strength.
HA Dissolution Rate and Solubility Product	Acceptable dissolution rate and solubility product for HA coating.	HA coating demonstrated acceptable dissolution rate and solubility product.
MR Compatibility (ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, ASTM F2119-07)	MR Safe/Conditional as per standards.	Device evaluated as MR compatible according to the standards.
Biocompatibility (ISO 10993-1)	Biocompatible for its intended use and contact duration.	Device was found to be biocompatible.

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

The document does not specify the exact sample sizes used for each mechanical or material test. These tests typically involve a defined number of samples according to the specific ASTM or ISO standard being followed. Data provenance is implied to be from Smith & Nephew's internal testing labs or contracted testing facilities, as these are non-clinical (laboratory) studies. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

This is not applicable. For mechanical and material testing of implants, "ground truth" is established by the specifications defined in recognized national and international standards (e.g., ISO, ASTM). The "experts" are the engineers and material scientists conducting and interpreting these standardized tests, whose qualifications are inherent in their ability to perform such tests according to regulatory requirements. No clinical expert consensus is involved in establishing the "truth" for these non-clinical tests.

4. Adjudication method for the test set

Not applicable. Mechanical and material tests follow defined methodologies in their respective standards. The results are quantitative and directly measured against pre-defined acceptance criteria, not subject to subjective adjudication.

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, as this is not an AI/ML-driven diagnostic device.

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

Not applicable, as this is not an AI/ML-driven diagnostic device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is based on:

Engineering specifications and design requirements: Derived from the predicate devices and industry best practices.
Recognized national and international standards: Such as ISO (e.g., ISO 7206, ISO 21535, ISO 10993, ISO 13779) and ASTM (e.g., ASTM F2996, ASTM F1147, ASTM F1044, ASTM F1160, ASTM F2182, ASTM F2052, ASTM F2213, ASTM F2119). These standards define acceptable performance metrics for medical devices of this type.

8. The sample size for the training set

Not applicable, as this is not an AI/ML-driven diagnostic device.

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

Not applicable, as this is not an AI/ML-driven diagnostic device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

June 27, 2024

Smith & Nephew Inc. Chelsea Bagley Sr. Regulatory Affairs Specialist 1450 Brooks Rd Memphis, Tennessee 38116

Re: K240381

Trade/Device Name: CATALYSTEM 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: LZO, MEH, LPH Dated: February 7, 2024 Received: May 31, 2024

Dear Chelsea Bagley:

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/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.

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"

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(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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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 and Part 809); 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-safetyreporting-combination-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.

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-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. Christopher Ferreira -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K240381

Device Name CATALYSTEM Femoral Stems

Indications for Use (Describe)

The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

The CATALYSTEM Femoral Stems are intended for use without bone cement.

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) #: K240381	510(k) Summary	Prepared on: 2024-06-27
Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Smith & Nephew Inc.
Applicant Address	1450 Brooks Rd Memphis TN 38116 United States
Applicant Contact Telephone	4705058820
Applicant Contact	Mrs. Chelsea Bagley
Applicant Contact Email	chelsea.bagley@smith-nephew.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	CATALYSTEM Femoral Stems
Common Name	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis
Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented OrNon-Porous, Uncemented
Regulation Number	888.3353
Product Code(s)	LZO, MEH, LPH
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K143739	POLARSTEM Collared (Standard and Lateral) and Valgus Femoral	LZO
K052792	ANTHOLOGY Hip Stem	JDI
Device Description Summary21 CFR 807.92(a)(4)
The purpose of this Traditional 510(k) is to notify the FDA of our intent to market the Smith & Nephew CATALYSTEM Femoral Stems. TheCATALYSTEM Femoral Stems consists of femoral stem implants intended for primary hip arthroplasty in skeletally mature patients. The

CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarhitis, avascular necrosis, and traumatic arthritis.

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The CATALYSTEM Femoral Stems are intended for use without bone cement.

Indications for Use Comparison

The indications for use of the subject device were updated to clarify the type of hip arthroplasty they are indicated for.

Technological Comparison

The overall technological characteristics including device design, function, materials and intended use for the CATALYSTEM Femoral Stems are substantially equivalent to the predicate Smith & Nephew systems cleared under the premarket notifications ANTHOLOGY Hip Stems (K052792, 10/07/2005) and POLARSTEM Hip Stems (K143739, 04/20/2015). The indications for use of the subject device were updated to clarify the type of hip arthroplasty they are indicated for.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Mechanical Testing and Analyses

· Distal Fatigue Testing per ISO 7206-4 and ASTM F2996-20
· Neck Fatigue Testing per ISO 7206-6 and ASTM F2996-20
· Range of Motion (ROM) Evaluation per ISO 21535
· Engineering Analysis of Impingement Performance
· Fretting and Corrosion Performance Rationale
· Femoral Head Disassembly Performance Rationale

Hydroxyapatite (HA) Coating Testing

· Chemical Characterization per ASTM F1980-21, ISO 13779-2 and ISO 13779-3
· Static Tensile Attachment Strength Testing per ASTM F1 147-05 and ISO 13779-4
· Static Shear Attachment Testing per ASTM F1044-05R17e01
· Shear Fatigue Strength Testing per ASTM F1044-05R17e01 and ASTM F1160-14
· Dissolution Rate and Solubility Product

MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017 and ASTM F2119-07 Biocompatibility per ISO 10993-1

No clinical tests were performed to support safety and efficacy of the subject device.

The performance mechanical and coating testings and analyses were used as a basis for the determination of substantial equivalence. The results of each of these tests show that when compared to the subject device has met the required acceptance criteria and there are no additional risks. As such, the CATALYSTEM Femoral Stems are substantially equivalent to the predicate devices for the intended use.

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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.