(124 days)
Not Found
No
The 510(k) summary describes a mechanical hip implant system and the performance studies are focused on biocompatibility and mechanical testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
This device is a hip implant, which is a prosthetic device designed to replace damaged or diseased parts of the hip joint. Its intended use includes treating conditions like advanced hip degeneration, fractures, and failures of previous hip surgeries, all of which are medical conditions that require intervention to restore function and alleviate symptoms. Therefore, by directly addressing these medical conditions and aiming to improve a patient's health and quality of life, it functions as a therapeutic device.
No
The device is an acetabular hip cup prosthesis, specifically an implant for total hip replacement, used to treat conditions like advanced hip degeneration, femoral head fractures, or failed previous hip surgeries. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implantable device made of titanium alloy and stainless steel, intended for surgical implantation in the hip joint. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to replace or repair a damaged hip joint. This is a therapeutic and structural function within the body.
- Device Description: The description details the materials and design of an artificial hip joint component (acetabular shell and dual mobility system). These are physical implants.
- Performance Studies: The performance studies focus on biocompatibility and mechanical testing of the implant's structural integrity and interaction with bone and other components. This is typical for implantable medical devices, not IVDs.
- 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) to provide information for diagnosis, monitoring, or screening.
In summary, the device is a surgical implant designed to replace a damaged hip joint, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 REDAPT Porous Acetabular Shell for use with the POLARCUP Dual Mobility System is intended for single use only and is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
LPH, OQG, KWZ, LZO, JDI, KWY
Device Description
The REDAPT Porous Acetabular Shell is designed for cementless use on the boneinterfacing surface and is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of liners into the shell and incorporates screw holes for fixation.
The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). POLARCUP Shell is made from Stainless Steel. The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. The POLARCUP™ Dual Mobility System is an acetabular hip cup prosthesis.
The subject device consists of a REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System. The REDAPT Porous Acetabular Shell is intended to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.
The purpose of this 510(k) submission is to modify the indications for the REDAPT Porous Acetabular Shell to allow for a dual mobility use when used with the POLARCUP Dual Mobility System.
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
Not Found
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:
A biocompatibility evaluation was conducted for the combination usage of non-cemented REDAPT Porous Acetabular Shell with the cemented POLARCUP Dual Mobility System.
The evaluation was 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 devices are classified as permanent, >30 day body contact according to ISO-10993.
Materials: REDAPT Porous Acetabular Shells are made of titanium-6 aluminum-4 vanadium (Ti-6Al-4V) alloy, meeting ASTM F1472 standard. POLARCUP Shell is made from Stainless Steel INOX M30NW (ISO 5832-9). POLARCUP XLPE Insert is made from ultra-high molecular weight polyethylene (UHMWPE) and highly cross-linked UHMWPE (XLPE), meeting ISO 5834-1/2.
Results: Biocompatibility evaluation has been completed and a summary rationale has been provided.
Mechanical testing:
Non-clinical bench (mechanical) testing was conducted on the proposed REDAPT Porous Acetabular Shell with the cemented POLARCUP Dual Mobility System.
Test results demonstrated that the proposed devices are substantially equivalent to the predicate REDAPT Porous Acetabular Shell System.
Mechanical tests/assessments completed were:
- Environmental Corrosion Fatigue
- Fatigue
- Post Fatigue Push-Out
- Lever Out
- Torque to Failure
- Range of Motion
- Tolerance Stack Analysis
Results: The subject devices with pre-determined acceptance criteria met the acceptance criteria for all outputs.
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.
K150790, K110135, K150522, K072121
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
September 24, 2018
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Smith & Nephew, Inc. Bryan Cowell Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K181366
Trade/Device Name: REDAPT Porous Acetabular Shells 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, OQG, KWZ, LZO, JDI, KWY Dated: August 28, 2018 Received: August 29, 2018
Dear Bryan Cowell:
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
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel S. Ramsey -S 2018.09.24 11:56:55 -04'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181366
Device Name REDAPT Porous Acetabular Shell
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, 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 REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System is intended for single use only and is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with 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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510(k) Summary Smith & Nephew REDAPT Porous Acetabular Shells
| SUBMITTER:
I. | Smith & Nephew, Inc.
Orthopaedic Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: (901) 396-1633
Fax: (901) 566-7159 |
| | Contact Person: Michael Scott
Date Prepared: September 7, 2018 |
| II.
DEVICE | |
| Name of Device:
Common Name:
Regulatory Class: | REDAPT Porous Acetabular Shells
Acetabular Component
2 |
| Classification Name,
Regulation Number,
Product Codes, | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis (CFR 888.3358) LPH
Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis (CFR 888.3358)OQG
Hip joint metal/polymer constrained cemented or uncemented
prosthesis (CFR 888.3310) KWZ
Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (CFR 888.3353) LZO
Hip joint metal/polymer semi-constrained cemented prosthesis
(CFR 888.3350)JDI
Hip joint femoral (hemi-hip) metal/polymer cemented or
uncemented prosthesis (888-3390) KWY |
| PREDICATE DEVICE | Primary Predicate REDAPT Porous Acetabular Shells: K150790
(S.E. 11/16/2015)
Predicate 2: POLARCUP Dual Mobility System: K110135 (S.E.
10/14/2011)
Predicate 3: G7 Dual Mobility System: K150522 (S.E. 05/01/2015)
Predicate 4: Trabecular Metal Acetabular Revision System
Cemented Constrained Liner K072121 (S.E. 01/07/2008) |
The predicate devices have not been subject to a design related recall.
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DEVICE DESCRIPTION III.
The REDAPT Porous Acetabular Shell is designed for cementless use on the boneinterfacing surface and is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of liners into the shell and incorporates screw holes for fixation.
The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). POLARCUP Shell is made from Stainless Steel. The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. The POLARCUP™ Dual Mobility System is an acetabular hip cup prosthesis.
The subject device consists of a REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System. The REDAPT Porous Acetabular Shell is intended to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.
The purpose of this 510(k) submission is to modify the indications for the REDAPT Porous Acetabular Shell to allow for a dual mobility use when used with the POLARCUP Dual Mobility System.
INDICATIONS FOR USE IV.
- 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
5
The REDAPT Porous Acetabular Shell for use with the POLARCUP Dual Mobility System is intended for single use only and is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
There are no technological differences between the subject and predicate REDAPT Porous Acetabular Shells K150790 (S.E. 11/16/2015).
There are no technological differences between the POLARCUP Dual Mobility System components and the previously cleared POLARCUP Dual Mobility System components K110135 (S.E. 10/14/2011).
To allow for a dual mobility option for the existing REDAPT Porous Acetabular Shells, this submission allows for the existing POLARCUP Dual Mobility System to be implanted in the REDAPT Porous Acetabular Shells with bone cement.
As the devices are identical to the existing 510(k) cleared devices, the technological characteristics assessed consisted of the compatibility of the two systems.
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.
Therefore, the technological characteristics of the subject device are the similar to the technological characteristics of the predicate devices REDAPT Porous Acetabular Shells (S.E. (K150790 (S.E. 11/16/2015) and POLARCUP Dual Mobility System (S.E. K150522 (S.E. 05/01/2015)).
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VI. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility
As part of the compatibility assessment, a biocompatibility evaluation was completed for the combination usage of non-cemented REDAPT Porous Acetabular Shell with the cemented POLARCUP Dual Mobility System.
The biocompatibility evaluation for the combination usage of non-cemented REDAPT Porous Acetabular Shell with the cemented POLARCUP Dual Mobility System 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 REDAPT Porous Acetabular Shell with the POLARCUP Dual Mobility System 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 REDAPT Porous Acetabular Shells are made of titanium-6 aluminum-4 vanadium (Ti-6Al-4V) alloy. The material is considered surgical grade and meets ASTM F1472 standard specification. The Ti-6Al-4V alloy meets the quality and chemical composition given in Smith & Nephew Specifications.
The cemented POLARCUP Shell is made from Stainless Steel INOX M30NW meeting the requirement of ISO 5832-9. The POLARCUP XLPE Insert is made from ultra-high molecular weight polyethylene (UHMWPE) and highly cross-linked UHMWPE (XLPE). The material is considered surgical grade meeting the requirements of ISO 5834-1/2. The quality and processing of the material is controlled by Smith and Nephew specifications.
7
Biocompatibility evaluation has been completed and a summary rationale has been provided for the subject LEGION Finned Tibial Wedges.
Mechanical testing
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on the proposed REDAPT Porous Acetabular Shell with the cemented POLARCUP Dual Mobility System. Test results demonstrated that the proposed devices are substantially equivalent to the predicate REDAPT Porous Acetabular Shell System.
Mechanical tests/assessments completed were:
- Environmental Corrosion Fatigue
- Fatigue .
- Post Fatigue Push-Out ●
- Lever Out ●
- Torque to Failure ●
- Range of Motion .
- Tolerance Stack Analysis ●
The subject devices with pre-determined acceptance criteria met the acceptance criteria for all outputs.
CONCLUSIONS VII.
Based on the verification evidence activities provided in the pre-market notification, the subject REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System is substantially equivalent to the legally marketed predicate devices: REDAPT Porous Acetabular Shells: K150790 (S.E. 11/16/2015), POLARCUP Dual Mobility System: K110135 (S.E. 10/14/2011). G7 Dual Mobility System: K150522 (S.E. 05/01/2015) and Trabecular Metal Acetabular Revision System Cemented Constrained Liner K072121 (S.E. 01/07/2008).