K Number

Device Name

Manufacturer

Smith & Nephew, Inc.

Date Cleared

2022-07-01

(437 days)

Product Code

LPH,JDI,KWY,KWZ,LZO,MBL,MEH

Regulation Number

888.3358

Type

Traditional

Panel

Orthopedic

Predicate For

K231448,K240783,K242375

Intended Use

The components are indicated for the following:

Non-inflammatory degenerative joint disease including osteonecrosis, avascular necrosis and post traumatic arthritis;
Rheumatoid arthritis;
Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
Revision procedures where other treatment or devices have failed; and
Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

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/D) 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 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 indications for use in total hip arthoplasty include rheumatoid arthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.

Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head
Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
All forms of osteoarthritis
Patients with hips at risk of dislocation
Femoral neck fracture or proximal fracture to hip joint
The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only.
The components are intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.
The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.

Device Description

The purpose of this Traditional 510(k) is to add "MR Conditional" labeling to the subject Smith & Nephew Hip Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the devices' design, material, sterilization and the manufacturing processes of the previously cleared devices.

AI/ML Overview

This document is a 510(k) Premarket Notification from Smith & Nephew, Inc. for various Hip Systems. The purpose of this submission is to add "MR Conditional" labeling to these hip systems.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes MR Conditional labeling, meaning the devices have been tested and found to be safe for use in specific MRI environments. The acceptance criteria are based on established standards for MRI compatibility.

Test Parameter / Acceptance Criteria (Standard)	Reported Device Performance (Summary from study)
Magnetically Induced Displacement Force (ASTM F2052-15)	Not explicitly detailed, but implied to be within safe limits for "MR Conditional" labeling.
Magnetically Induced Torque (ASTM F2213-2017)	Not explicitly detailed, but implied to be within safe limits for "MR Conditional" labeling.
Radiofrequency (RF) Induced Heating (ASTM F2182-19e2)	Not explicitly detailed, but implied to be within safe limits for "MR Conditional" labeling.
MR Image Artifacts (ASTM F2119-07 (2013))	Not explicitly detailed, but implied to be assessed and within acceptable limits for "MR Conditional" labeling.
General MR Safety for Active Implantable Medical Devices (ISO/TS 10974:2018(E))	Implied the devices meet relevant safety aspects, although these are passive implants.
Basic Safety and Essential Performance of MRI Equipment (IEC 60601-2-33 (Ed 3.2))	Implied the devices are compatible with equipment meeting this standard.

Key takeaway: The document confirms that "Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance and the Standards listed" to support the "MR Conditional" labeling. However, it does not provide specific data points (e.g., maximum temperature rise, angular deflection, or translational force metrics) for each test. Instead, it makes a general statement that the testing supports the MR Conditional claim.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in terms of patient data or clinical images, as the study is focused on the physical devices' compatibility with MRI environments, not clinical performance or diagnostic accuracy.

The studies were conducted on the devices themselves (hip systems and their components). The provenance is implied to be laboratory testing based on the referenced ASTM and ISO standards for MRI compatibility. The data is prospective in the sense that the tests were performed to demonstrate compliance for new labeling.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this type of submission. The "ground truth" here is established by the scientifically validated test methods and established standards (e.g., ASTM, ISO, IEC) for MRI compatibility, not by expert consensus on clinical cases. The tests themselves define the "ground truth" for the physical properties being measured (e.g., magnetic susceptibility, RF heating).

4. Adjudication Method for the Test Set:

This is not applicable as the studies are physical/engineering tests against objective standards, not interpretation of clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is used to assess the diagnostic performance of an AI algorithm in comparison to or in conjunction with human readers. This submission is for the "MR Conditional" labeling of hip systems, which is a safety and functional characteristic of the physical implant, not a diagnostic AI device.

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

No, a standalone algorithm performance study was not done. This submission is not for an algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these "MR Conditional" studies is objective physical measurements conducted according to recognized international consensus standards (ASTM, ISO, IEC) and FDA guidance documents. These standards define the acceptable limits for parameters like magnetically induced displacement, torque, and RF-induced heating.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/machine learning device requiring a training set. The "training" for the hip systems refers to their design and manufacturing to meet performance specifications.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as this is not an AI/machine learning device. The "ground truth" for the design and manufacturing of the hip systems is established through engineering principles, material science, biomechanical testing, and adherence to quality systems and regulatory requirements, which are inherent to their previous clearances. The ground truth for the MR Conditional labeling is established by the referenced MRI compatibility test standards.

Summary

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Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

Smith & Nephew, Inc. Michelle Huettner Director, Regulatory Affairs, Orthopaedic Division 1450 East Brooks Rd Memphis. Tennessee 38116

Re: K211176

Trade/Device Name: Smith & Nephew Hip Systems Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, LPH, MEH, LZO, KWY, MBL, KWZ Dated: May 31, 2022 Received: June 1, 2022

Dear Rose Beifuss:

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 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

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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 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,

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:

List of Cleared Devices in K211176

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List of Cleared Devices in K211176

1. Anthology Hip System MR Conditional
1. BH Dual Mobility System MR Conditional
1. Contour Acetabular System MR Conditional
1. CPCS Cemented Hip System MR Conditional
1. Echelon Hip System MR Conditional
1. Femoral Heads MR Conditional
1. HI Cup MR Conditional
1. Modular Hip Stems MR Conditional
1. POLARCUP MR Conditional
1. POLARSTEM MR Conditional,
1. R3 Acetabular System MR Conditional
1. Redapt Monoblock Revision Femoral System MR Conditional
1. Redapt Revision Acetabular System MR Conditional
1. Reflection Acetabular System Metal Shell MR Conditional
1. Reflection All-Poly Cup MR Conditional
1. Short Monoblock Femoral (SMF) Hip System MR Conditional
1. SL-Plus and SLR-Plus Cementless Femoral Hip System MR Conditional
1. Spectron EF Hip System MR Conditional
1. Synergy Hip System MR Conditional
1. Tandem Bipolar/Unipolar Hip System MR Conditional

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510(k) Number (if known)

K211176

Device Name

Tandem Bipolar/Unipolar Hip System

Indications for Use (Describe)

The components are indicated for the following:

Non-inflammatory degenerative joint disease including osteonecrosis, avascular necrosis and post traumatic arthritis;
Rheumatoid arthritis;
Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
Revision procedures where other treatment or devices have failed; and
Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

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.

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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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known)

K211176

Device Name Synergy Hip System

Indications for Use (Describe)

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid 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; fracture dislocation of the hip; and correction of deformity.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Spectron EF Hip System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

510(k) Number (if known)

K211176

Device Name

SL-Plus and SLR-Plus Cementless Femoral Hip System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{7}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Short Monoblock Femoral (SMF) Hip System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{8}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Reflection All-Poly Cup

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{9}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Reflection Acetabular System - Metal Shell

Indications for Use (Describe)

The components are intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{10}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Redapt Revision Acetabular System

Indications for Use (Describe)

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; fracture dislocation of the hip; and correction of deformity.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{11}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Redapt Monoblock Revision Femoral System

Indications for Use (Describe)

			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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{12}------------------------------------------------

510(k) Number (if known)

K211176

Device Name R3 Acetabular System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{13}------------------------------------------------

510(k) Number (if known)

K211176

Device Name POLARSTEM

Indications for Use (Describe)

Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head
Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement

The POLARSTEM with Ti/HA is intended for single use only and is to be implanted 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)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{14}------------------------------------------------

510(k) Number (if known)

K211176

Device Name POLARCUP

Indications for Use (Describe)

Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head
Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
All forms of osteoarthritis
Patients with hips at risk of dislocation
Femoral neck fracture or proximal fracture to hip joint

The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{15}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Modular Hip Stems

Indications for Use (Describe)

The indications for use in total hip arthoplasty include rheumatoid arthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{16}------------------------------------------------

510(k) Number (if known)

K211176

Device Name HI Cup

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{17}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Femoral Heads

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{18}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Echelon Hip System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{19}------------------------------------------------

510(k) Number (if known)

K211176

Device Name CPCS Cemented Hip System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{20}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Contour Acetabular System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{21}------------------------------------------------

510(k) Number (if known)

K211176

Device Name BH Dual Mobility System

Indications for Use (Describe)

The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{22}------------------------------------------------

510(k) Number (if known)

K211176

Device Name Anthology Hip System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{23}------------------------------------------------

510(k) Summary

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Submission:	31May2022
Contact Person:	Rose BeifussRegulatory Affairs Specialist IIT +1.385.253.2551
Name of Device:	Smith & Nephew Hip Systems: Anthology HipSystem, BH Dual Mobility System, ContourAcetabular System, CPCS Cemented Hip SystemEchelon Hip System, Femoral Heads, HI CupModular Hip Stems, Polarcup, Polarstem, R3Acetabular System, Redapt Monoblock RevisionFemoral System, Redapt Revision AcetabulaSystem, Reflection Acetabular System - Metal ShellReflection All-Poly Cup, Short Monoblock Femora(SMF) Hip System, SL-Plus and SLR-PlusCementless Femoral Hip System, Spectron EF HipSystem, Synergy Hip System and TandemBipolar/Unipolar Hip System.
Common Name:	Hip Stem, Acetabular Component, , Prosthetic HipJoint- HA Coated Porous Femoral Stem, Femoral
	Component, Cementless, Acetabular Liners, FemoralHip Prosthesis, Total Hip Joint, AcetabularComponent, Constrained Liner, Bipolar System
Device Classification Nameand Reference:	21 CFR 888.3350- Hip joint metal/polymer semi-constrained cemented prosthesis,21 CFR 888.3358 – Hip joint metal/polymer/metalsemi-constrained porous-coated uncementedprosthesis,CFR 888.3390- Hip joint femoral (hemi-hip)metal/polymer cemented or uncemented prosthesis,21 CFR 888.3353- Hip joint metal/ceramic/polymersemi-constrained cemented or nonporousuncemented prosthesis,21 CFR 888.3360 – Hip joint femoral (hemi-hip)metallic cemented or uncemented prosthesis21 CFR 888.3310 Prothesis, hip, constrained,cemented or uncemented metal/polymer
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	JDI , LPH, MEH, LZO, KWY, MBL, KWZ
Primary Predicate Device:	Anthology Hip System

Femoral

Heads and Acetabular Liners, Total Hip Joint,

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Additional Predicate Devices: BH Dual Mobility System, Contour Acetabular System, CPCS Cemented Hip System, Echelon Hip System, Femoral Heads, HI Cup, Modular Hip Stems, Polarcup, Polarstem, R3 Acetabular System, Redapt Monoblock Revision Femoral System, Redapt Revision Acetabular System, Reflection Acetabular System - Metal Shell, Reflection All-Poly Cup, Short Monoblock Femoral (SMF) Hip System, SL-Plus and SLR-Plus Cementless Femoral Hip System, Spectron EF Hip System, Synergy Hip System and Tandem Bipolar/Unipolar Hip System.

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Device Description:

No modifications have been made to the devices' design, material, sterilization and the manufacturing processes of the previously cleared devices.

Indications for Use:

Total Hip Systems

Anthology, Contour Acetabular, CPCS Cemented, Echelon, Femoral Heads, HI Cup, R3 Acetabular, Redapt Monoblock Revision Femoral, Redapt Revision Acetabular, Reflection All-Poly Cup, Short Monoblock Femoral, SL-Plus and SLR-Plus Cementless Femoral, Spectron EF, Synergy, BH Dual Mobility

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Modular Hip Stems

The indications for use in total hip arthroplasty include rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.

POLARCUP

Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head

1. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis,
  hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
1. All forms of osteoarthritis
1. Patients with hips at risk of dislocation
1. Femoral neck fracture or proximal fracture to hip joint

The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> ThePOLARCUP Dual Mobility System is intended for single use only.

POLARSTEM

Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis

1. Fracture or avascular necrosis of the femoral head
1. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis,

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hemiarthroplasty, surface replacement arthroplasty, or total hip replacement

The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.

Reflection Acetabular System - Metal Shell

The components are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.

BH Dual Mobility System

The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BH) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.

Partial Hip Systems

Tandem Bipolar/Unipolar

Tandem Bipolar/Unipolar Hip System

The components are indicated for the following:

1. Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
1. Rheumatoid arthritis;
1. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
1. Revision procedures where other treatment or devices have failed; and
1. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

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Technological Characteristics

The device design and material of the subject devices are the same as the predicate Smith & Nephew Hip Systems cleared under the premarket notifications listed in Table 6.1.

Performance Data

Below listed Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance and the Standards listed below.

1. FDA Guidance Document: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff", 20 May 2021.
1. Reporting of Computational Modeling Studies in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, September 21, 2016
1. IEC 60601-2-33 (Ed 3.2), "Medical electrical equipment -Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" (2015).
1. ASTM F2182-19e2, "Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging" (2020).
1. ISO/TS 10974:2018(E) "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device".
1. ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
1. ASTM F2213-2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
1. ASTM F2182-19 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging
1. ASTM F2119-07 (2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

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Substantial Equivalence Information

The subject Smith & Nephew Hip Systems are identical in design, technological characteristics, function of the devices, packaging and sterilization to the commercially available predicate devices listed in Table 6.1 below. The only differences between the subject devices and the commercially available predicate devices were supporting MR safety testing/assessment and the addition of "MR Conditional" information to the labeling.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew,Inc.	Anthology Hip System	K052792	10/07/2005
Smith & Nephew,Inc.	BH Dual Mobility System	K171934	11/30/2017
Smith & Nephew,Inc.	Contour Acetabular System	K962541 K040680	09/17/199606/14/2004
Smith & Nephew,Inc.	CPCS Cemented Hip System	K970351 K823727	02/28/199703/08/1983
Smith & Nephew,Inc.	Echelon Hip System	K983834 K023302 K963486	02/24/199910/25/200211/27/1996
Smith & Nephew,Inc.	Femoral Heads	K021673 K022902 K022958 K072817 K083762 K093363 K100412 K110101 K914878 K963509 K971414	06/11/200210/02/200210/02/200205/15/200803/11/200901/26/201005/05/201004/11/201107/30/199201/27/199707/16/1997
Smith & Nephew,Inc.	HI Cup	K093991	04/15/2010
Smith & Nephew,Inc.	Modular Hip Stems	K921400 K900628	04/02/199305/09/1990
Smith & Nephew,Inc.	POLARCUP	K070278 K110135 K122244	04/16/200710/14/201108/23/2012
Smith & Nephew,Inc.	POLARSTEM	K130728 K143739	10/10/201304/20/2015
Smith & Nephew,Inc.	R3 Acetabular System	K070756 K083566 K092386 K093363 K102370 K113848 K182535	06/06/200703/03/200911/03/200901/26/201001/19/201104/27/201211/19/2018
Smith & Nephew,Inc.	Redapt Monoblock RevisionFemoral System	K081124 K100481 K121627 K151902 K162303	07/31/200807/15/201010/15/201209/03/201505/01/2017
Smith & Nephew,Inc.	Redapt Revision AcetabularSystem	K150790 K160923 K171073 K182109	11/16/201511/17/201611/21/201711/16/2018
Smith & Nephew,Inc.	Reflection Acetabular System -Metal Shell	K002747 K021803 K022556 K022902 K033442 K071160 K920430 K932755 K990666 K960094	12/15/200012/19/200208/28/200210/02/200211/26/200310/05/200707/21/199205/06/199408/06/199903/27/1996
Smith & Nephew,Inc.	Reflection All-Poly Cup	K002747	12/15/2000
Smith & Nephew,Inc.	Short Monoblock Femoral (SMF)Hip System	K103256 K123012	01/31/201110/24/2012
Smith & Nephew,Inc.	SL-Plus and SLR-Plus CementlessFemoral Hip System	K072852 K093991 K120211 K122296	06/09/200804/15/201007/19/201208/28/2012
Smith & Nephew,Inc.	Spectron EF Hip System	K823723 K831884 K970351 K791125	03/09/198309/20/198302/28/199706/27/1979
Smith & Nephew,Inc.	Synergy Hip System	K002996 K963509 K970337 K990369 K991485	12/11/200001/27/199702/28/199703/12/199907/12/1999
Smith & Nephew,Inc.	Tandem Bipolar/Unipolar HipSystem	K023743 K896580 K934353	01/23/200302/15/199004/25/1994

Table 6.1: Predicate Devices

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Conclusion

In summary, the only differences between the subject devices and the commercially available predicate devices were supporting MR safety testing/assessment and the addition of MR safety information to the labeling. These differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the subject devices. The subject Smith & Nephew Hip Systems are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared and do not affect the safety and effectiveness of the subject devices when used as labeled. Due to the supporting documentation within this filing, it is conducted that the subject device(s) are substantially equivalent to the predicate device(s).

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.