(59 days)
Not Found
No
The 510(k) summary describes a mechanical hip implant system and focuses on adding MR safety information. There is no mention of AI or ML in the device description, intended use, or performance studies. The testing described relates to MRI compatibility, not AI/ML performance.
No.
The device is an implant system used in total hip arthroplasty to treat conditions like advanced degeneration, fractures, and failure of previous hip surgeries. It replaces or reconstructs the hip joint rather than providing therapy.
No
Explanation: The OR3O Dual Mobility System is an implantable device used in total hip arthroplasty, not for diagnosing conditions. Its purpose is to replace parts of the hip joint. The 510(k) submission is specifically to add MR safety information for the device, which is an assessment of the device's compatibility with MRI, not a diagnostic use of the device itself.
No
The device description clearly states it is a modular dual mobility implant system consisting of physical components like a metal acetabular shell, liner, insert, and femoral head. The 510(k) is specifically for adding MR safety information to the labeling of these physical implants.
Based on the provided information, the OR3O Dual Mobility System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a surgical implant used to replace or reconstruct the hip joint in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a modular implant system consisting of metal and polyethylene components designed for implantation within the body. This is consistent with a surgical implant.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status through in vitro testing.
- Focus on MRI Compatibility: The primary purpose of this 510(k) submission is to add and update MR safety information for the device, which is relevant for implanted devices that may be exposed to MRI environments. This further supports its classification as a surgical implant.
In summary, the OR3O Dual Mobility System is a surgical implant intended for therapeutic use in hip arthroplasty, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The OR30 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: ioint 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.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The OR3O Hip System was originally cleared via K220959. The OR3O Hip System is a modular dual mobility implant system containing two distinct articulating surfaces. The hip system consists of a metal acetabular shell, diffusion hardened oxdized zirconium (OXINIUM DH) alloy liner, a cross-linked polyethylene (XLPE) Insert and a femoral head.
The purpose of this Taditional 510(k) is to add the MR safety information to the product labels and update the MR information within the package insert for the Snith & Nephew OR3O Dual Mobility System included within the scope of this 510(k). The subject OR30 Dual Mobility System is identical in design, technological characteristics, function, packaging, and sterilization to the commercially available predicate devices.
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)
Magnetic Resonance Imaging (MRI) compatibility testing was performed and the results of the testing performed were evaluated and used to generate recommended MRI safety labeling for the subject devices. Testing and evaluation were performed in accordance with the standards listed below:
-
- Magnetically induced displacement force (ASTM F2052)
-
- Magnetically induced torque (ASTM F2213)
-
- Radiofrequency (RF) induced heating (ASTM F2182)
-
- MR image artifact (ASTM F2119)
Based on the MR assessment performed for the subject devices are MR Conditional and substantially equivalent to the predicate MRI 510(k) K211176.
- MR image artifact (ASTM F2119)
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.
K220959, K191002, K232667, K211176
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 7, 2024
Smith & Nephew, Inc. Dana Hartlein Senior Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116
Re: K242375
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: August 9, 2024 Received: August 9, 2024
Dear Dana Hartlein:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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 -S
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
3
Indications for Use
Submission Number (if known)
Device Name
OR30 Dual Mobility System
Indications for Use (Describe)
The OR30 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: ioint 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.
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)
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Page 1 of 3
| 510(k) Summary | Prepared on: 2024-10-07 | |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Smith & Nephew, Inc. | |
| Applicant Address | 1450 East Brooks Road Memphis TN 38116 United States | |
| Applicant Contact Telephone | 484-557-4768 | |
| Applicant Contact | Ms. Dana Hartlein | |
| Applicant Contact Email | dana.hartlein@smith-nephew.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | OR3O Dual Mobility System | |
| Common Name | Hip Prothesis | |
| Classification Name | Hip joint metal/polymer/metal semi-constrained porous-coated | |
| uncemented prosthesis | ||
| Regulation Number | 888.3358 | |
| Product Code(s) | LPH | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K220959 | OR3O Dual Mobility System | LPH |
| K191002 | OR3O Dual Mobility System | LPH |
| K232667 | OR3O Dual Mobility Liners | LPH |
| K211176 | Smith & Nephew Hip Systems - MR Labeling and Design Change | JDI |
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K232375
Page 2 of 3
Device Description Summary
The OR3O Hip System was originally cleared via K220959. The OR3O Hip System is a modular dual mobility implant system containing two distinct articulating surfaces. The hip system consists of a metal acetabular shell, diffusion hardened oxdized zirconium (OXINIUM DH) alloy liner, a cross-linked polyethylene (XLPE) Insert and a femoral head.
The purpose of this Taditional 510(k) is to add the MR safety information to the product labels and update the MR information within the package insert for the Snith & Nephew OR3O Dual Mobility System included within the scope of this 510(k). The subject OR30 Dual Mobility System is identical in design, technological characteristics, function, packaging, and sterilization to the commercially available predicate devices.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The OR 30 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, hemiathroplasty, surface replacement athroplasty, 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.
Indications for Use Comparison
The subject OR3O Dual Mobility System has identical indications for use as the commercially available predicate cleared via the premarket notifications listed above.
Technological Comparison
The subject Smith & Nephew OR3O Dual Mobility System is identical in design, material, technological characteristics, function of the devices, sterile packaging, and sterilization to the commercially available predicate devices cleared in K220959 (08/18/2022), K191002 (10/31/2019), and K232667(10/27/2023). The subject 510(k) is being submitted to add MR safety information to the product labels and update the MR information within the package insert of the OR30 Dual Mobility System previously cleared in K220959 (08/18/2022), K191002 (10/31/2019), and K232667 (10/27/2023).
21 CFR 807 92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(4)
6
K232375
Page 3 of 3
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
Indications for Use Comparison
The subject OR30 Dual Mobility System has identical indications for use as the commercially available premarket notifications listed above.
Technological Comparison
The subject Smith & Nephew OR3O Dual Mobility System is identical in design, material, technological characteristics, function of the devices, sterile packaging, and sterilization to the commercially available predicate devices cleared in K.20959 (08/18/2022), K191002 (10/31/2019), and K232667(10/27/2023). The subject 510(k) is being submitted to add MR safety information to the product labels and update the MR information within the package insert of the OR3O Dual Mobility System previously cleared in K220959 (08/18/2022), K191002 (10/31/2019), and K232667(10/27/2023).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Magnetic Resonance Imaging (MRI) compatibility testing was performed and the results of the testing performed were evaluated and used to generate recommended MRI safety labeling for the subject devices. Testing and evaluation were performed in accordance with the standards listed below:
-
- Magnetically induced displacement force (ASTM F2052)
-
Magnetically induced torque (ASTM F2213)
-
Radiofrequency (RF) induced heating (ASTM F2182)
-
MR image artifact (ASTM F2119)
Based on the MR assessment performed for the subject devices are MR Conditional and substantially equivalent to the predicate MRI 510(k) K211176.