(139 days)
No
The 510(k) summary describes a mechanical implant system for hip replacement and a line extension of existing components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
This device is an implant for total hip arthroplasty, which is a therapeutic intervention to treat conditions like advanced hip joint degeneration, fractures, and failures of previous hip surgeries.
No
The provided text describes a hip implant system intended for surgical use in total hip arthroplasty, not for diagnosing medical conditions.
No
The device description clearly details physical implant components (liners, inserts, shells, femoral heads) made of various materials, indicating it is a hardware medical device.
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 in skeletally mature patients." This describes a surgical implant used to replace a damaged hip joint.
- Device Description: The description details the components of a hip implant system (liners, inserts, shells, femoral heads) made of various materials like oxidized zirconium, titanium alloy, and polyethylene. These are all materials used in surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for testing purposes.
The device described is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The OR30 Hip System is a modular dual mobility implant system consists of diffusion hardened oxidized zirconium (OXINIUM DH) alloy liners with a highly polished zirconium oxide inner surface and a machined locking taper and backside of Zr2.5Nb alloy (F2384-10R16). The locking taper and outside profile is designed to mate with a dedicated Ti6Al4V R3 acetabular shell with OD sizes 44mm to 74mm or REDAPT Modular Press-fit acetabular shell with OD sizes 48mm to 74mm. For each assembled OR30 liner and R3 shell size from 44mm to 74mm and REDAPT Modular shell size from 48mm to 74mm, a dedicated insert is available. Inserts are made of highly crosslinked ultra-high-molecularweight polyethylene (ISO 5834-2/ASTM F648) that is irradiated with a 10 Mrad dose and remelted . These can be combined with oxidized zirconium or CoCr alloy femoral heads of sizes 22 mm (for Size 44mm-52mm) and 28 mm (for size 50mm-74mm). The final OR30 Dual Mobility construct will include an acetabular shell (with optional screws and optional screw hole covers), an OXINIUM DH Liner, a cross linked polyethylene (XLPE) Insert and a femoral head.
The purpose of this Traditional 510(k) submission is to add additional components, namely additional sizes of the OR3O Dual Mobility OXINIUM DH Liners and OR3O Dual Mobility XLPE Inserts to the existing OR30 Dual Mobility System.
This line extension will consist of two smaller size OXINIUM DH Liners and four additional XLPE inserts to allow for a wider range of implant options for physicians to choose from. The materials and manufacturing processes will be the same, with the exception of accounting for different sized 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)
Biocompatibility evaluation for the OR3O Dual Mobility Implants was conducted in accordance with FDA's 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 OR30 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".
Mechanical testing was performed for the OR30 Dual Mobility System to demonstrate substantial equivalence to predicate devices.
Testing included: ASTM F1820 (Push Out Testing, Torque to Failure Testing, Lever-Out Testing), ASTM F1875 (Environmental Fatigue and Corrosion Assessment), ISO 7206-12 (Deformation Testing), ASTM F2582 (Neck Impingement Testing), ISO 21535-2009 (Range of Motion), ISO 14242 (Wear Testing), and N/A (Jump Distance, Insert Pull-Out Testing, Insert Lever-out Testing). Biomechanical testing and/or rationales were completed on the subject devices.
Non-Pyrogenicity Endotoxin Testing was completed, meeting acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72.
Key results: The subject OR3O Dual Mobility devices met the pre-determined acceptance criteria for each intended output.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
OR3O Dual Mobility System - K191002, POLARCUP Dual Mobility System - K110135, REFLECTION Hip System - K071160, REFLECTION Hip System - K932755, BH Dual Mobility System - K171934
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K092386, K182109, K110101, K963509, K963486
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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August 18, 2022
Smith & Nephew, Inc. Rose Beifuss Senior Manager, Regulatory Affairs 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K220959
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: July 14, 2022 Received: July 15, 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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,
Limin Sun, Ph.D. 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: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
OR30 Dual Mobility System
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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3
510(k) Summary Smith & Nephew OR3O Dual Mobility System
| I. | SUBMITTER | Smith & Nephew, Inc.
Orthopaedics Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
| ---- | ----------- | ---------------------------------------------------------------------------------------------------------- |
|---|
Phone: (385) 253-2551
Contact Person: Rose Beifuss, Senior Manager, Regulatory Affairs Date Prepared: August 15, 2022
II. DEVICE
| Name of Device: | OR3O Dual Mobility System |
|---|---|
| Common Name: | Hip Prosthesis |
| Regulatory Class: | Class II |
| Product Code: | LPH |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated |
| uncemented prosthesis, | |
| (21 CFR888.3358) |
| PREDICATE DEVICE | Primary Predicate: OR3O Dual Mobility System - |
|---|---|
| K191002 (S.E. 10/31/2019) | |
| Predicate 2: POLARCUP Dual Mobility System - | |
| K110135 (S.E. 10/14/2011) | |
| Predicate 3: REFLECTION Hip System - | |
| K071160 (S.E. 10/05/2007) | |
| Predicate 4: REFLECTION Hip System - | |
| K932755 (S.E. 05/06/1994) | |
| Predicate 5: BH Dual Mobility System - | |
| K171934 (S.E. 11/30/2017) |
The predicate devices have not been subject to a design related recall.
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III. DEVICE DESCRIPTION
The OR30 Hip System is a modular dual mobility implant system consists of diffusion hardened oxidized zirconium (OXINIUM DH) alloy liners with a highly polished zirconium oxide inner surface and a machined locking taper and backside of Zr2.5Nb alloy (F2384-10R16). The locking taper and outside profile is designed to mate with a dedicated Ti6Al4V R3 acetabular shell with OD sizes 44mm to 74mm or REDAPT Modular Press-fit acetabular shell with OD sizes 48mm to 74mm. For each assembled OR30 liner and R3 shell size from 44mm to 74mm and REDAPT Modular shell size from 48mm to 74mm, a dedicated insert is available. Inserts are made of highly crosslinked ultra-high-molecularweight polyethylene (ISO 5834-2/ASTM F648) that is irradiated with a 10 Mrad dose and remelted . These can be combined with oxidized zirconium or CoCr alloy femoral heads of sizes 22 mm (for Size 44mm-52mm) and 28 mm (for size 50mm-74mm). The final OR30 Dual Mobility construct will include an acetabular shell (with optional screws and optional screw hole covers), an OXINIUM DH Liner, a cross linked polyethylene (XLPE) Insert and a femoral head.
The purpose of this Traditional 510(k) submission is to add additional components, namely additional sizes of the OR3O Dual Mobility OXINIUM DH Liners and OR3O Dual Mobility XLPE Inserts to the existing OR30 Dual Mobility System.
This line extension will consist of two smaller size OXINIUM DH Liners and four additional XLPE inserts to allow for a wider range of implant options for physicians to choose from. The materials and manufacturing processes will be the same, with the exception of accounting for different sized implants.
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IV. INDICATIONS FOR USE
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, 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. •
The OR3O Dual Mobility System is intended for single use only. The modular OR3O 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 V. PREDICATE 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: OR3O Dual Mobility System - K191002 (S.E 10/31/2019), POLARCUP Dual Mobility System - K110135 (S.E. 10/14/2011), REFLECTION Hip System - K071160 (S.E. 10/05/2007) - REFLECTION Hip System (K932755 S.E. 05/06/1994), BH Dual Mobility System - K171934 (S.E. 11/30/2017)
The subject device includes two implant components to form a dual mobility concept where there are two articulating surfaces in the same joint space:
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LINER
- The subject OR30 Dual Mobility System Liner uses an OXIDIZED DH Zirconium . (OXINIUM DH) material with a highly polished inner surface identical to the predicate OR3O Dual Mobility System - K191002 (S.E 10/31/2019). The OR3O Dual Mobility Liners have a locking taper and are designed to mate with existing Smith & Nephew R3 (K092386 – S.E. 11/03/2009) or REDAPT Modular Shell - K182109 (S.E. 11/16/2018).
INSERT
-
The subject OR30 Dual Mobility XLPE material is identical to the predicate OR3O ● Dual Mobility XLPE material - OR3O Dual Mobility K191002 (S.E 10/31/2019), with only minor design iterations made to allow for smaller size implants. Both the subject and predicate OR30 Dual Mobility XLPE Inserts are intended to be used as an articulating component of the OR30 Dual Mobility System.
The OR30 Dual Mobility Liners and OR30 Dual Mobility 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 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).
PERFORMANCE DATA VI.
The following performance data are provided in support of the substantial equivalence determination.
Biocomnatibility
The biocompatibility evaluation for the OR3O Dual Mobility Implants was conducted in accordance with FDA's Guidance for Industry and FDA Staff "Use of International Standard
7
ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process".
The subject OR30 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 OR30 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 OR3O 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-highmolecular-weight polyethylene. Moulded forms).
A biocompatibility evaluation has been completed and a Declaration of Conformity's has been provided for the OR3O Dual Mobility System line extension.
Mechanical testing
Smith & Nephew has evaluated the subject OR30 Dual Mobility System to demonstrate substantial equivalence to the predicate devices: OR3O Dual Mobility System - K191002 (S.E 10/31/2019), POLARCUP Dual Mobility System - K110135 (S.E. 10/14/2011), REFLECTION Hip System – K071160 (S.E. 10/05/2007), REFLECTION Hip System (K932755 S.E. 05/06/1994) and BH Dual Mobility System - K171934 (S.E. 11/30/2017), and determined that the subject devices do not represent a new worst case.
8
| Standard | Testing |
|---|---|
| ASTM F1820 | Push Out Testing Torque to Failure Testing Lever-Out Testing |
| ASTM F1875 | Environmental Fatigue and Corrosion Assessment |
| ISO 7206-12 | Deformation Testing |
| ASTM F2582 | Neck Impingement Testing |
| ISO 21535-2009 | Range of Motion |
| ISO 14242 | Wear Testing |
| N/A | Jump Distance Insert Pull-Out Testing Insert Lever-out Testing |
Biomechanical testing and/ or rationales were completed on the subject devices as follows:
9
The subject OR3O 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-Pvrogenicity Endotoxin Testing
Bacterial endotoxin testing was completed and met the acceptable endotoxin limit 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 VII.
Based on the verification evidence activities provided in this pre-market notification application, the subject OR3O Dual Mobility System is substantially equivalent to the legally marketed primary predicate device - OR3O Dual Mobility System - K191002 (S.E 10/31/2019), and the other predicates: POLARCUP Dual Mobility System - K110135 (S.E. 10/14/2011), REFLECTION Hip System K071160 (S.E. 10/05/2007), REFLECTION Hip System -K932755 (S.E. 05/06/1994) and BH Dual Mobility System - K171934 (S.E. 11/30/2017).