(198 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant materials and design, with no mention of AI or ML.
Yes
The device is intended for use in total hip arthroplasty to treat advanced degeneration of the hip joint, fractures, and avascular necrosis, which are therapeutic interventions.
No
This device is an implant for total hip arthroplasty, not a tool for diagnosing medical conditions.
No
The device description clearly outlines a physical implant system consisting of liners, inserts, shells, and femoral heads made of various materials. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "primary and revision total hip arthroplasty." This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The description details a modular implant system consisting of liners, inserts, shells, and femoral heads, all designed to be surgically implanted in the hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is an implantable medical device used inside the body to replace a damaged hip joint.
N/A
Intended Use / Indications for 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.
Product codes
LPH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
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:
- Push Out Testing
- Torque to Failure Testing
- Lever-Out Testing
- Environmental Fatigue Testing
- Deformation Testing
- Wear Testing
- Pull-Out Testing
- Neck Impingement Testing
- Range of Motion
- Jump Distance
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
POLARCUP Dual Mobility System -K110135, REFLECTION Hip System -K071160, BH Dual Mobility System -K171934, OXINIUM DH Femoral Heads -K161233
Reference Device(s)
Smith & Nephew R3 Shells - K092386, REDAPT Modular Press-fit acetabular shells - K182109, OXINIUM Femoral Heads K110101, Cobalt Chrome Femoral Heads -K963509, K963486
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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.
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3
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-coated |
| uncemented 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.
4
K191002 Page 2 of 6
Device Description IV.
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.
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. .
5
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.
6
-
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).
7
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
8
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).