Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atturitis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.

The R3 Acetabular System is for single use only and is intended for cementless use.

Device Description

The subject of this Traditional 510k is the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm). The R3 Large Head Liners are a line extension to the existing R3 Acetabular System. The R3 Large Head Liners were previously cleared for market via premarket notification K113848. The head size of the liners are being increased to include sizes 28mm X 44mm, 32mm X 46mm, and 36mm X 50mm (inner diameter and outer diameter, respectively) in 0 and 20-degree versions. The R3 Large Head Liners are intended for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "R3 Large Head Liners" and focuses on demonstrating substantial equivalence to predicate devices, rather than the performance of a device based on a clinical study against specific acceptance criteria. This submission is for a medical device (hip joint components), not a diagnostic AI/ML device, and therefore the acceptance criteria and study types typically associated with AI/ML device clearance (like those around clinical performance metrics, reader studies, etc.) are not present in this document.

However, based on the information provided, I can extract the relevant "performance testing" conducted to support the substantial equivalence claim.

Here's an interpretation of the information within the provided context:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the traditional sense of a numerical threshold for a diagnostic accuracy study. Instead, it refers to performance testing used to establish substantial equivalence to predicate devices. The "reported device performance" is that the device met the requirements of these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Pass Lever-Out test	Met requirements
Pass Push-Out test	Met requirements
Pass Torque-Out test	Met requirements
Pass Fatigue test	Met requirements
Pass Post Fatigue Push-Out test	Met requirements
Pass Biocompatibility test	Met requirements
Pass Impingement test	Met requirements
Pass Range of Motion test	Met requirements
Pass Wear test	Met requirements
Meet acceptable endotoxin limits (Bacterial endotoxin testing)	Met acceptable endotoxin limits as stated in FDA Guidance

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

Sample Size: Not explicitly stated for each test. The tests are bench (mechanical) tests performed on the physical device, not on human data.
Data Provenance: Not applicable in the context of human data. These are laboratory bench tests.

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

This is not applicable as the "ground truth" for these mechanical tests is determined by standardized test methodologies and measurements, not expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. Adjudication methods are used in studies involving human interpretation (e.g., of medical images) to resolve discrepancies.

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:

No. This is a submission for a physical medical implant, not an AI/ML diagnostic device, so an MRMC study is not relevant here.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used:

The "ground truth" for these tests are the objective measurements obtained from standardized mechanical and biocompatibility testing. For example, for "Lever-Out," the ground truth would be the measured force required for lever-out, compared against an established performance specification.

8. The sample size for the training set:

Not applicable. These are physical device tests, not machine learning model evaluations.

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

Not applicable. There is no "training set" in this context.

Summary

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January 19, 2022

Image /page/0/Picture/1 description: The image contains the logo for 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.

Smith & Nephew, Inc. Kayla Franklin Regulatory Affairs Specialist I 7135 Goodlett Farms Parkway Cordova. Tennessee 38016

Re: K211330

Trade/Device Name: R3 Large Head Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI, LZO, MEH Dated: December 17, 2021 Received: December 20, 2021

Dear Kayla Franklin:

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

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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,

for

Limin Sun, Ph.D. Acting 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K211330

Device Name R3 Large Head Liners

Indications for Use (Describe)

The R3 Acetabular System is for single use only and is intended for cementless use.

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)

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:

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510(k) Summary

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Submission:	January 18, 2022
Contact Person:	Kayla Franklin, Regulatory Affairs Specialist IT (901) 800-3398M (901) 325-2471
Name of Device:	R3 Large Head Liners
Common Name:	Acetabular Liners
Device Classification Nameand Reference:	21 CFR 888.3358 - Hip joint metal/polymer/metalsemi-constrained porous-coated uncementedprosthesis.
Device Class:	Class II
Panel Code:	Orthopedics/87
Product Code:	LPH (primary), JDI, LZO, MEH
Predicate Device:	R3 Large Head Liners

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Device Description:

Indications for Use

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracturedislocation of the hip; and correction of deformity.

The R3 Acetabular System is for single use only and is intended for cementless use.

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Technological Characteristics

Device comparisons described in this premarket notification demonstrate that the subject devices, R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm - 36mm X 50mm), are substantially equivalent to the below listed legally marketed predicate devices (Table 6.1) with regard to intended use, indications for use, design, material and performance characteristics. Identical to that of the predicate R3 Large Head Liners cleared via premarket notification K113848 (S.E. 04/27/12), the subject R3 Large Head 0 and 20-degree implant liners (28mm X 44mm – 36mm) are also made from Cross Linked Polyethylene (XLPE), undergo the same manufacture process, have the same surface finish, and the same locking mechanism. The subject and predicate R3 liners also have similar inner and outer diameters, as well as being offered in similar design options. Additionally, the predicate R3 36mm XLPE Liners, K092386 (S.E. 11/03/09) and predicate R3 40 and 44mm XLPE Liners, K093363 (S.E. 01/26/10) have similar head sizes to that of the subject R3 Large Head liners.

Substantial Equivalence Information

The overall design, materials, and indications for use for the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm) are substantially equivalent to the predicate devices listed in Table 6.1 below. In addition to the similarities stated above in the Technological Characteristics, the subject devices also utilize the same sterilization method as their predicates. While the subject devices are not identical in design to the predicate devices, any differences that may exist between the subject device and the predicates identified below do not significantly affect the safety or effectiveness of the device.

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Table 6.1: Predicate Devices

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew,Inc.	R3 XLPE Liners (PrimaryPredicate)	K113848	04/27/12
Smith & Nephew,Inc.	R3 36mm XLPE Liners	K092386	11/03/09
Smith & Nephew,Inc.	R3 40 and 44mm XLPE Liners	K093363	01/26/10
Smith & Nephew,Inc.	REFLECTION 32mm X 50-52mmXLPE Acetabular Liner	K002747	12/15/00

Performance Testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was performed on the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm). A review of the testing indicates that the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm) are substantially equivalent to predicate devices listed in Table 6.1 above.

The following tests were used as a basis for the determination of substantial equivalence. The testing included the following:

Lever-Out
Push-Out .
Torque-Out ●
Fatigue ●
Post Fatigue Push-Out ●
Biocompatibility ●
Impingement ●
Range of Motion ●
Wear .

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Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.

Conclusion

In summary, this 510(k) Premarket Notification is being submitted to request clearance for the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm). Based on the similarities to the predicate devices and a review of the bench testing, the subject devices are substantially equivalent to the commercially available predicate devices listed above.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.