· 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 hip joint fracture.

The OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Mating components may be indicated for use without bone cement.

Device Description

The OR30 Hip System is a modular dual mobility implant system. The system consists of diffusion hardened, oxidized zirconium alloy liners with a highly polished inner surface of zirconia and a machined locking taper and backside of Zr-2.5Nb alloy. The locking taper and machined outside profile is designed to mate with a dedicated Ti 6Al 4V R3 or REDAPT Modular Press-fit acetabular shell with OD sizes 48mm to 74mm. For each assembled OR30 Liner and R3 and REDAPT Modular Shell size from 48mm to 74mm, a dedicated plastic insert made of highly crosslinked ultrahigh-molecular-weight polyethylene (10Mrad irradiated and remelt-annealed UHMWPE (XLPE) according to ISO 5834-2/ASTM F648) is available. These can be combined with oxidized zirconium or CoCr alloy femoral heads of sizes 22mm (for size 48mm-52mm) and 28mm (for size 54mm-74mm). The final OR30 Dual Mobility construct will include an acetabular shell, an OXINIUM DH Liner, an XLPE Insert and a femoral head.

The purpose of this 510(k) submission is to add additional options of dual mobility implants to the Smith & Nephew collection of hip implants.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the OR30 Dual Mobility System, and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria and study data for a diagnostic device in the usual sense (e.g., performance metrics like sensitivity, specificity, or AUC). Instead, the performance data provided is for biocompatibility and mechanical testing of the implantable device.

Therefore, many of the requested categories for a diagnostic device's acceptance criteria and study data (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary.

I will interpret the request within the context of the provided document, focusing on the "acceptance criteria" for the mechanical testing of the OR30 Dual Mobility System, as this is the closest equivalent to performance evaluation in this type of submission.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric (Mechanical Testing)	Acceptance Criteria	Reported Device Performance
Push Out Testing	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Torque to Failure Testing	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Lever-Out Testing	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Environmental Fatigue Testing	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Deformation Testing	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Wear Testing	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Pull-Out Testing	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Neck Impingement Testing	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Range of Motion	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Jump Distance	Pre-determined acceptance criteria (not explicitly defined in document)	Met pre-determined acceptance criteria
Biocompatibility	In accordance with FDA's Draft Guidance for ISO-10993	Report evaluation completed and rationales provided
Non-Pyrogenicity Endotoxin Testing	Met acceptable endotoxin limits per FDA Guidance and ANSI/AAMI ST72	Met acceptable endotoxin limits

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the mechanical or biocompatibility tests.
Data provenance is not mentioned. It can be inferred that testing was conducted as part of the device development and submission process, likely by the manufacturer or a contracted lab. This is industrial testing, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device intended to be implanted. "Ground truth" for mechanical testing is based on engineering specifications and adherence to standards, not expert clinical interpretation of data.

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

Not applicable, as this refers to clinical evaluation and consensus building for diagnostic accuracy, which is not part of this submission.

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 is a physical implantable device, not a diagnostic AI system or a system requiring human interpretation.

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

Not applicable. This is a physical implantable device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For mechanical testing: The "ground truth" or reference for performance is established by pre-determined acceptance criteria based on engineering standards (e.g., ASTM, ISO), regulatory guidelines, and comparison to predicate devices, ensuring the device meets safety and performance requirements for its intended use. The document states the device "met the pre-determined acceptance criteria for each intended output."
For biocompatibility: Ground truth is adherence to international standards like ISO-10993.
For non-pyrogenicity: Ground truth is adherence to established endotoxin limits in FDA Guidance and ANSI/AAMI ST72.

8. The sample size for the training set

Not applicable. This is a physical implantable device; there is no "training set" in the context of machine learning or diagnostic device development.

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

Not applicable, as there is no training set mentioned in this context.

Summary

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Image /page/0/Picture/10 description: The image shows the logo of 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

Smith & Nephew, Inc. Mike Scott Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K191002

Trade/Device Name: OR30 Dual Mobility System 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 Dated: September 20, 2019 Received: September 23, 2019

Dear Mike Scott:

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

October 31, 2019

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 Vesa Vuniqi 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191002

Device Name OR30 Dual Mobility

Indications for Use (Describe) Intended Use The OR3O Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.

Indications

· 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 hip joint fracture.

The OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Mating components may be indicated 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)

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:

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"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."

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510(k) Summary Smith & Nephew OR30 Dual Mobility System

I. SUBMITTER: Smith & Nephew, Inc. Orthopaedic Division 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Phone: (901) 396-1633

Contact Person: Michael Scott Date Prepared: October 29, 2019

II. DEVICE

Name of Device:	OR3O Dual Mobility System
Common Name:	Hip Prosthesis
Regulatory Class:	Class II
FDA Product Code:	LPH
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis,(21 CFR888.3358)

III. PREDICATE DEVICE Primary Predicate: POLARCUP Dual Mobility System -K110135 (S.E. 10/14/2011) Predicate 2: REFLECTION Hip System -K071160 (S.E. 10/05/2007) Predicate 3: BH Dual Mobility System -K171934 (S.E. 11/30/2017) Predicate 4: OXINIUM DH Femoral Heads -K161233 (S.E. 12/14/2016)

The predicate devices have not been subject to a design related recall.

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K191002 Page 2 of 6

Device Description IV.

The purpose of this 510(k) submission is to add additional options of dual mobility implants to the Smith & Nephew collection of hip implants.

INDICATIONS FOR USE V.

Intended User

The OR3O Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.

Indications

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 hip joint fracture. .

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The OR3O Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Mating components may be indicated for use without bone cement.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

The subject OR3O Dual Mobility System implants have the same or similar intended use, fundamental scientific technology, materials, and indications for use as the following FDA cleared predicates: POLARCUP Dual Mobility System - K110135 (S.E. 10/14/2011)), REFLECTION Hip System – K071160 (S.E. 10/05/2007), BH Dual Mobility System - K171934 (S.E. 11/30/2017) and OXINIUM DH Femoral Heads - K161233 (S.E. 12/14/2016).

The subject device includes two new implant components to form a dual mobility concept where there are two articulating surfaces in the same joint space:

LINER

The subject OR30 Dual Mobility System Liner uses an OXIDIZED DH Zirconium ● (OXINIUM DH) material with a highly polished inner surface similar to the predicate POLARCUP Dual Mobility inner surface - K110135 (S.E. 10/14/2011). The subject OXINIUM DH Liner has a locking taper and is designed to mate with an existing Smith & Nephew R3 (K092386 – S.E. 11/03/2009) or REDAPT Modular Shell - K182109 (S.E. 11/16/2018).
The predicate device POLARCUP Dual Mobility System K110135 (S.E. 10/14/2011) 0 contains an XLPE Liner which is designed to articulate against a Stainless Steel POLARCUP Dual Mobility Shell.

INSERT

The subject OR3O Dual Mobility Insert contains an XLPE Liner which is designed to o articulate against the subject OR30 Dual Mobility Liner.

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The subject XLPE Material and Design are identical to the predicate BH Dual Mobility 0 Material and Design - K171934 (S.E. 11/30/2017). Both the subject and predicate XLPE Inserts are intended to be used as an articulating component of a dual mobility system.
The subject OR30 Liner and OR30 Inserts are intended to be used with existing Smith & Nephew Acetabular Shells and Femoral Heads:
Existing Acetabular Shells The OR30 Dual Mobility System uses existing Smith & . Nephew R3 Shells - K092386 (S.E. 11/03/2009) or Smith & Nephew REDAPT Modular Press-fit acetabular shells - K182109 (S.E. 11/16/2018).
Existing Femoral Heads The OR3O Dual Mobility System uses existing Smith & Nephew o OXINIUM Femoral Heads K110101 (S.E. 04/11/2011) or Cobalt Chrome Femoral Heads -K963509 (S.E. 01/27/1997) and K963486 (S.E. 11/27/1996).

VII. PERFORMANCE DATA

The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation for the OR3O Dual Mobility Implants and Instruments was conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process".

The subject OR3O Dual Mobility Implants are permanent implants and will be classified as permanent, >30 day body contact according to ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process".

The subject OR3O Dual Mobility Liners are manufactured from Zr-2.5Nb alloy materials in accordance with the following ASTM standard: F2384- 10R16 Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901).

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The subject OR30 Dual Mobility Inserts are manufactured from identical polyethylene XLPE materials as the predicate device, in accordance with the following standards: ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ISO 5834-2 - Implants for surgery. Ultra-high-molecular-weight polyethylene. Moulded forms.

Instruments to support the OR3O Dual Mobility Implants have also been assessed for biocompatibility. The device specific implant OR30 Trial Liners have been manufactured from Radel PPSU (polyphenylsulfone) and the OR30 Trial Inserts are manufactured from Radel PPSU (polyphenylsulfone).

A biocompatibility report evaluation has been completed and summary rationales including Declaration of Conformity's have been provided for the subject OR30 Dual Mobility System.

Mechanical testing

Smith & Nephew has evaluated the subject OR3O Dual Mobility System to demonstrate substantial equivalence to the predicate POLARCUP Dual Mobility K110135 (S.E. 10/14/2011) and REFLECTION Hip System – K071160 (S.E. 10/05/2007) and determined that the subject devices do not represent a new worst case.

Biomechanical testing completed on the subject devices:

o Push Out Testing
Torque to Failure Testing .
Lever-Out Testing 0
Environmental Fatigue Testing ●
. Deformation Testing
Wear Testing ●
Pull-Out Testing .
Neck Impingement Testing ●
Range of Motion ●
Jump Distance

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The subject OR30 Dual Mobility devices met the pre-determined acceptance criteria for each intended output. Therefore, design verification testing determined that the subject OR3O Dual Mobility System is substantially equivalent to the identified predicate devices.

Non-Pyrogenicity Endotoxin Testing

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 "Bacterial endotoxins – Test methods, routine monitoring and alternatives to batch testing".

CONCLUSIONS VIII.

Based on the verification evidence activities provided in this pre-market notification the subject OR30 Dual Mobility System is substantially equivalent to the legally marketed predicate devices POLARCUP Dual Mobility K110135 (S.E. 10/14/2011), REFLECTION Hip System K071160 (S.E. 10/05/2007), BH Dual Mobility K171934 (S.E. 11/30/2017), and OXINIUM DH Femoral Heads - K161233 (S.E. 12/14/2016).

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.