Exeter X3 RimFit Cup: The indications for use for total hip arthroplasty include: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or madequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. The Exeter X3 RimFit Cup is intended for cemented use only.

Exeter V40 Femoral Stem: The indications for use for total and hemi hip arthroplasty include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

Device Description

The subject Exeter X3 RimFit Cup sterilized by ethylene oxide (EtO) is referred to throughout this submission as the Exeter X3-EtO RimFit Cup. The subject Exeter X3-EtO RimFit Cup is a modified version of the predicate Exeter X3 RimFit Cup and features an alternate terminal sterilization method with EtO, an additional polyethylene resin consolidation method (conventional method which meets the specifications of ASTM F648), an alternate cement spacer material in Acrylic Resin Colacryl® TS2270 PMMA, minor dimensional changes related to flange diameter and blow hole locations, and newly introduced Magnetic Resonance (MR) Conditional labeling. The geometry and design of the subject Exeter X3-EtO RimFit Cup is similar to the predicate Exeter X3 RimFit Cup. There are minor modifications to the flange diameter and blow hole locations between the subject Exeter X3-EtO RimFit Cup and predicate Exeter X3 RimFit Cup. The alternate terminal sterilization method and polyethylene resin consolidation method were previously cleared for Stryker Orthopaedics knee devices in K173849 and Stryker Orthopaedics hip devices in K182468. The alternate cement spacer material was previously cleared in K191414. The MR Conditional labeling was previously cleared in K171768.

The subject Exeter X3 RimFit Cup sterilized via gas plasma (GP) is referred to throughout this submission as the Exeter X3-GP RimFit Cup and has device designs identical to the predicate Exeter X3 RimFit Cup in terms of design and geometry. In comparison to the predicate Exeter X3 RimFit Cup, the only change to the subject Exeter X3-GP RimFit Cup is that the labeling is updated to add MR Conditional information. The MR Conditional language was previously cleared in K171768.

The subject Exeter V40 Femoral Stem is a modified version of the predicate Exeter V40 Femoral Stem in that the stem component is packaged with two polymethyl methacrylate (PMMA) centralizers that are manufactured from an alternate PMMA material (Acrylic Resin Colacryl® TS2270 PMMA). The alternate PMMA material was previously cleared in K191414. The subject device is identical to the predicate device in terms of design and geometry. The labeling for the subject device maintain the MR Conditional designation that was previously cleared in K171768 and K174399 (certain sizes of Exeter V40 Femoral Stem only).

AI/ML Overview

This document, K193429, is a 510(k) premarket notification for hip replacement devices (Exeter V40 Femoral Stem, Exeter X3 RimFit Cup). It does not describe an AI/ML powered device or a study involving human readers or expert ground truth establishment for a diagnostic output. Instead, it focuses on demonstrating substantial equivalence of modified conventional medical devices to legally marketed predicate devices through non-clinical bench testing, material testing, biocompatibility evaluation, sterilization validation, and MRI compatibility analysis.

Therefore, many of the requested criteria related to AI/ML device performance, reader studies, and ground truth establishment are not applicable.

Here's an attempt to address the applicable parts of your request based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document outlines non-clinical testing to demonstrate substantial equivalence, rather than a clinical performance study with acceptance criteria for a diagnostic output. The "acceptance criteria" here are implicitly tied to the successful completion and positive results of the listed non-clinical tests, demonstrating the modified devices meet established standards and are safe and effective.

Acceptance Criterion (Implicitly Met by Testing)	Reported Device Performance (Summary of Test Outcome)
Exeter X3-EtO RimFit Cup
Material Properties (conformance to ASTM F648, ASTM F2565 and FDA Guidance)	Material testing was performed, implying conformance.
Biocompatibility (conformance to ISO 10993-1, ISO 10993-7, and FDA Guidance)	Biocompatibility evaluation was performed, implying compliance.
Ethylene Oxide Sterilization Effectiveness (conformance to ISO 11135:2014)	Ethylene oxide sterilization validation was performed, implying effectiveness.
Bacterial Endotoxin Levels (met BET standards)	Bacterial endotoxin testing (BET) was performed, implying acceptable levels.
MRI Safety and Compatibility (conformance to FDA Guidance)	MRI Analysis was conducted to characterize compatibility, implying acceptable safety and compatibility.
Shelf Life/Stability (demonstrated by Accelerated Aging Studies)	Accelerated Aging Studies of PMMA coupons were performed.
Dimensional Stability Post Cleaning/Sterilization	Effect of Cleaning and Sterilization on Dimensional Stability of PMMA was studied.
Exeter X3-GP RimFit Cup
MRI Safety and Compatibility (conformance to FDA Guidance)	MRI Analysis was conducted to characterize compatibility, implying acceptable safety and compatibility.
Exeter V40 Femoral Stem
Centralizer Insertion Performance	Centralizer Insertion testing was performed.
Centralizer Retention Performance	Centralizer Retention testing was performed.
Winged Centralizer Wing Flexibility	Winged Centralizer Wing Flexibility testing was performed.
Shelf Life/Stability (demonstrated by Accelerated Aging Studies)	Accelerated Aging Studies of PMMA coupons were performed.
MRI Safety and Compatibility (conformance to FDA Guidance)	MRI Analysis was conducted to characterize compatibility, implying acceptable safety and compatibility.

2. Sample sizes used for the test set and the data provenance:

Test Set Sample Sizes: The document does not specify exact sample sizes for each non-clinical test (e.g., how many material samples were tested, how many centralizers). This level of detail is typically found in the full test reports referenced by these summaries.
Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Stryker Orthopaedics/Howmedica Osteonics Corp). The document doesn't specify the country of origin for the data, but the company is based in Mahwah, New Jersey, USA. All data would be prospective in the sense that these tests were conducted specifically for this submission.

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 a study requiring expert readers to establish ground truth for a diagnostic output. The "truth" in this context is determined by the physical, chemical, and mechanical properties of the device as measured by standardized engineering and material science tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. This is not a study involving human readers or subjective interpretations requiring 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. This document is for a conventional hip implant and does not involve AI/ML or comparative effectiveness studies with human readers.

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

Not Applicable. This document is for a conventional hip implant and does not involve an algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests is established by objective, quantitative measurements against recognized industry standards (e.g., ASTM, ISO) and FDA guidance documents. Examples include:
- Material properties (e.g., tensile strength, wear rates)
- Biocompatibility assessments (e.g., cytotoxicity, sensitization)
- Sterilization effectiveness (e.g., sterility assurance level)
- Mechanical performance (e.g., centralizer retention force)
- MRI compatibility (e.g., induced heating, image artifact).

8. The sample size for the training set:

Not Applicable. This is not an AI/ML product; therefore, there is no training set mentioned or implied.

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

Not Applicable. As there is no training set for an AI/ML product, this question is not relevant.

Summary

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August 13, 2020

Image /page/0/Picture/1 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".

Howmedica Osteonics Corp Alexandra Kirby Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K193429

Trade/Device Name: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, LZO, JDG, KWY Dated: July 16, 2020 Received: July 17, 2020

Dear Alexandra Kirby:

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/cfpmp/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 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

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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 medical devices and radiation-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 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) K193429

Device Name Exeter® X3® RimFit Cup Exeter® V40™ Femoral Stem

Indications for Use (Describe) Exeter X3 RimFit Cup

The indications for use for total hip arthroplasty include:

· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis.

· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

· Where bone stock is of poor quality or madequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.

The Exeter X3 RimFit Cup is intended for cemented use only.

Exeter V40 Femoral Stem

The indications for use for total and hemi hip arthroplasty include:

· noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

• rheumatoid arthritis;

· correction of functional deformity;

· revision procedures where other treatments or devices have failed; and,

· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

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

☑ Research Use (Part 21 CFR 201.3 Subject to)	☐ Over-The-Counter (21 CFR 201.3 Subject to)
-------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Sponsor	Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Alexandra KirbyRegulatory Affairs SpecialistHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5963
Alternate Contact	Krutanjali ShahManager, Regulatory AffairsHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5665
Date Prepared:	December 9, 2019
Proprietary Name:	Exeter X3 RimFit CupExeter V40 Femoral Stem
Common Name:	Total and Hemi Hip Prosthesis
Classification Name:	Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR §888.3350)Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353)

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K193427 Page 2/7

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR §888.3360) Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR §888.3390)

Product Codes: JDI, LZO, JDG, KWY

Legally Marketed Device to Which Substantial Equivalence is Claimed:

. Exeter X3 RimFit Cup (K111848)
Exeter V40 Femoral Stem (K011623, K052718, K110290, K121308, K153345, . K173499)

Legally Marketed Reference Devices Used to Support Substantial Equivalence:

Trident®, Restoration ADM®, and MDM® X3 UHMWPE Acetabular Inserts (K182468) 0
Triathlon® X3 UHMWPE Tibial Inserts and Patellar Components (K172634) 0
. Exeter Centralizer and Exeter 2.5mm Intramedullary Plug (K191414)

Device Description:

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material was previously cleared in K191414. The MR Conditional labeling was previously cleared in K171768.

Indications for Use:

The subject Exeter X3 RimFit Cup and Exeter V40 Femoral Stem devices have the same intended use as their respective predicate devices as specified in the 510(k) submissions for the predicate devices and listed as follows.

Exeter X3 RimFit Cup

The indications for use for total hip arthroplasty include:

. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

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. Where bone stock is of poor quality or inadequate for other reconstructive techniques. such as cementless fixation, as indicated by deficiencies of the acetabulum.
The Exeter X3 RimFit Cup is intended for cemented use only.

Exeter V40 Femoral Stem

The indications for use for total and hemi hip arthroplasty include:

. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
rheumatoid arthritis; o
correction of functional deformity; o
revision procedures where other treatments or devices have failed; and, ●
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur o with head involvement that are unmanageable using other techniques.

The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

Summary of Technological Characteristics:

The subject Exeter X3-EtO RimFit Cup and Exeter V40 Femoral Stem are identical in terms of intended use, indications for use, and principles of operation to their respective predicate devices (Exeter X3 RimFit Cup and Exeter V40 Femoral Stem, respectively). The subject Exeter X3-EtO RimFit Cup and Exeter V40 Femoral Stem are similar in terms of technological characteristics to the predicate devices. There are noted differences between the subject and predicate devices as described in the Device Description header above. The geometry and design of the subject Exeter X3-EtO RimFit Cup is similar to the predicate Exeter X3 RimFit Cup. There are minor modifications to the flange diameter and blow hole locations between the subject Exeter X3-EtO RimFit Cup and predicate Exeter X3 RimFit Cup.

The subject Exeter X3-GP RimFit Cup is identical in terms of intended use, indications for use, and principles of operation to the predicate Exeter X3 RimFit Cup. The predicate Exeter X3

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RimFit Cup has been cleared in K111848. The change to add MR Conditional labeling to the existing Exeter X3 RimFit Cup does not impact the technological characteristics. The subject device has the same design and is manufactured from the same materials as the predicate Exeter X3 RimFit Cup.

Non-Clinical Testing:

The following non-clinical laboratory testing was performed to determine substantial eequivalence of the subject devices:

Exeter X3-EtO RimFit Cup

1. Material testing per ASTM F648, ASTM F2565, and FDA Guidance, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" (April 26, 2019).
1. Biocompatibility Evaluation per ISO 10993-1, ISO 10993-7, and FDA Guidance, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' (June 16, 2016)
1. Ethylene oxide sterilization validation per ISO 11135:2014
1. Bacterial endotoxin testing (BET)
1. MRI Analysis per the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and FDA Staff," dated December 11, 2014 was conducted to characterize the compatibility of Stryker Orthopaedics total hip passive implants in the MR environment. FDA guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance for Industry and FDA Staff", dated March 22, 2016 was also consulted for the heating evaluations performed.
1. Accelerated Aging Studies of PMMA coupons
1. Effect of Cleaning and Sterilization on the Dimensional Stability of PMMA

Exeter X3-GP RimFit Cup

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1. MRI Analysis per the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and FDA Staff," dated December 11, 2014 was conducted to characterize the compatibility of Stryker Orthopaedics total hip passive implants in the MR environment. FDA guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance for Industry and FDA Staff", dated March 22, 2016 was also consulted for the heating evaluations performed.

Exeter V40 Femoral Stem

1. Centralizer Insertion
1. Centralizer Retention
1. Winged Centralizer Wing Flexibility
1. Accelerated Aging Studies of PMMA coupons
1. MRI Analysis per the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and FDA Staff," dated December 11, 2014 was conducted to characterize the compatibility of Stryker Orthopaedics total hip passive implants in the MR environment. FDA draft guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance for Industry and FDA Staff," dated March 22, 2016 was also consulted for the heating evaluations performed.

Clinical Testing:

Clinical testing was not required as a basis for substantial equivalence.

Conclusion:

The subject Exeter X3 RimFit Cup and Exeter V40 Femoral Stem are substantially equivalent to the respective predicate devices identified in this premarket notification. Device comparison showed that the proposed devices are substantially equivalent in intended use, technological

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characteristics, and principles of operation as compared to the respective predicate devices. The proposed modifications do not affect safety and effectiveness.

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.