(267 days)
No
The summary describes a physical knee spacer device made of PMMA and gentamicin, with no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies focus on material properties and mechanical performance.
Yes
The device is indicated for temporary use as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic. It also allows for a natural range of motion and partial weightbearing during treatment of the infection, and preserves the soft tissue to prevent further complications.
No
The device is a temporary knee spacer intended for use as an adjunct to total knee replacement in patients undergoing a two-stage procedure due to a septic process. Its primary function is mechanical support and local antibiotic delivery, not the diagnosis of a condition.
No
The device is a physical implantable knee spacer made of polymethylmethacrylate and stainless steel, not software.
Based on the provided text, the Remedy Knee Spacer and Remedy Stemmed Knee Spacer are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Remedy Knee Spacer and Remedy Stemmed Knee Spacer are implantable medical devices designed to be surgically placed in the knee joint. Their function is to provide temporary support, allow for some mobility, and deliver antibiotics locally during the treatment of a septic process in the knee.
- Intended Use: The intended use clearly describes their application as an adjunct to total knee replacement in patients with a septic process, involving surgical implantation and subsequent removal. This is a therapeutic and supportive function within the body, not an in vitro diagnostic test.
Therefore, these devices fall under the category of implantable medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Remedy Knee Spacer, which consists of a Femoral Component and a Tibial Insert, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).
The device is applied on the femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the Tibial Insert is optional, when a large tibial defect is present.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The Remedy Knee Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.
The Remedy Stemmed Knee Spacer, which consists of a modular femoral, tibial and stem extension components, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).
The device is applied on the femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the stem extension component is optional to replace the space occupied by the previous femoral and/or tibial stem (dead space management). Moreover, if necessary, the tibial component could be coupled with the Osteoremedies Remedy Tibial Insert Wedge when a large tibial defect is present.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The Remedy Stemmed Knee Spacer is not intended for use tor more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.
Product codes
JWH
Device Description
The Remedy® Knee Spacer, cleared via K112470, is a temporary knee spacer device consisting of independent components (femoral component, tibial component and insert wedge) that can be combined one with each other depending on the anatomy of the patient. The cleared femoral components are available in three sizes (54mm, 64mm and 74mm). With this 510(k) submission. OsteoRemedies is adding the additional 84mm size (extra-large) to the FDA cleared range of Remedy Femoral Component.
The Remedy® Stemmed Knee Spacer is a temporary knee spacer device consisting of independent components (femoral component, tibial component and stem extension components) that can be combined one with each other depending on the anatomy of the patient. These components are available in different sizes to further accommodate variations in patient anatomy.
The Stem Extension Implant components can be coupled with both the femoral and the tibial components, as they are intended to be used, if necessary, to replace the space occupied by the previous femoral and/or tibial stem. The Remedy Stemmed Tibial component could also be coupled, if necessary, with the commercially marketed Remedy Tibial Insert Wedge (K112470), when a large tibial defect is present.
The Remedy Femoral Component 84mm and the Remedy Stemmed Knee Spacer are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacement. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liquid components. The liquid component consists of methylmethacrylate (MMA), N. N dimethyl-p-toluidine and hydroguinone; the powder component consists of PMMA, barium sulphate, benzovl peroxide and gentamicin sulphate. The stem components also present an inner core of Stainless Steel (AISI 316 ESR).
The devices (which consists of the combination of single components) provide patients a temporary complete knee implant that allows for a natural range of motion and partial weightbearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection. The devices are protected from bacterial adhesion due to the presence of gentamicin, similar to other spacers devices made with PMMA with antibiotics currently on the US market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Performance data was provided to establish substantial equivalence for the Remedy® Femoral Component 84mm and the Remedy® Stemmed Knee Spacer to the predicate device.
For the Remedy® Femoral Component 84mm, testing included:
- the static performances of the resin (ISO 5833)
- the fatigue performances of the resin (ASTM F2118)
- the surface roughness (ISO 4287)
- the range of motion (ASTM F2083)
- the device wear (ISO 14243-1)
- the antibiotic (gentamicin) elution testing.
Key results: The performance data demonstrate that the Remedy Femoral Component 84mm is substantially equivalent to the predicate device.
For the Remedy® Stemmed Knee Spacer, testing included:
- the static performances of the resin (ISO 5833)
- the fatigue performances of the resin (ASTM F2118)
- the surface roughness (ISO 4287)
- the tibial tray fatigue behavior (ASTM F1800)
- the fatigue behavior of the stem extensions
- the range of motion (ASTM F2083)
- the device wear (ISO 14243-1)
- the antibiotic (gentamicin) elution testing.
Key results: The performance data demonstrate that the Remedy Stemmed Knee Spacer is substantially equivalent to the predicate devices.
Additionally, Sterilization and Shelf Life studies were performed. The devices are sterilized using standard methods following international standards (UNI EN ISO 11135:2014; EC 1-2011 UNI EN ISO 11737-1:2006, UNI EN ISO 11737-2:2010, UNI EN ISO 10993-7:2009, UNI EN 556-1:2002, EP current Edition) with a sterility assurance level of 10-6. The shelf life was established through real-time and accelerated aging studies, demonstrating a shelf life of 45 months.
Biocompatibility evaluation was performed according to ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" to show the device materials are safe, biocompatible and suitable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OsteoRemedies LLC % Diane Horwitz Regulatory Affairs Consultant Mandell Horwitz Consultants LLC 2995 Steven Martin Drive Fairfax, Virginia 20031
Re: K183017
Trade/Device Name: Remedy® Femoral Component 84mm, Remedy® Stemmed Knee Spacer Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: June 26, 2019 Received: June 26, 2019
Dear Ms. Horwitz:
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, 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
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 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 (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.
Laurence D. Coyne -S
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183017
Device Name Remedy® Femoral Component 84mm
Indications for Use (Describe)
The Remedy Knee Spacer, which consists of a Femoral Component and a Tibial Insert, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).
The device is applied on the femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the Tibial Insert is optional, when a large tibial defect is present.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The Remedy Knee Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
3
Indications for Use
510(k) Number (if known) K183017
Device Name Remedy® Stemmed Knee Spacer
Indications for Use (Describe)
The Remedy Stemmed Knee Spacer, which consists of a modular femoral, tibial and stem extension components, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).
The device is applied on the femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the stem extension component is optional to replace the space occupied by the previous femoral and/or tibial stem (dead space management). Moreover, if necessary, the tibial component could be coupled with the Osteoremedies Remedy Tibial Insert Wedge when a large tibial defect is present.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The Remedy Stemmed Knee Spacer is not intended for use tor more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
4
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
GENERAL INFORMATION 1
Submitter and Owner of the 510(k) 1.1
OsteoRemedies LLC 6800 Poplar Avenue Suite 120 Memphis, TN 38138
Official Correspondent 1.2
Diane Mandell Horwitz, PhD, RAC Regulatory Affairs Consultant Mandell Horwitz Consultants, LLC 5 Lake Como Court Greenville, South Carolina 29609
Telephone: (703) 307-2921 E-mail: dmh(@mandellhorwitzconsulting.com
Devices Subject of this 510(k) 1.3
Remedy® Stemmed Knee Spacer Remedy® Femoral Component 84mm (Extra-Large)
1.4 Date of Preparation
July 24, 2019
NAME OF THE DEVICE AND CLASSIFICATION INFORMATION 2
2.1 Trade/Proprietary Name
Remedy® Stemmed Knee Spacer Remedy® Femoral Component 84mm
2.2 Common/Usual Name
Temporary Knee Spacer with Gentamicin
5
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
|---|---|
| Classification Regulation: | 888.3560 |
| Class: | II |
| Product Code(s): | JWH – prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer |
| Panel: | Orthopaedic |
Classification Information 2.3
ತಿ PREDICATE DEVICES
The predicate devices are as follows:
-
. Remedy® Knee Spacer which was cleared originally through 510(k) application K112470.
In addition, the Remedy Stemmed Knee Spacer and the Remedy Femoral Component 84mm (Extra-Large) have also been compared to the following device for certain technological characteristics: -
InterSpace Knee which was cleared through 510(k) application K181732. ●
DEVICE DESCRIPTION ব
The Remedy® Knee Spacer, cleared via K112470, is a temporary knee spacer device consisting of independent components (femoral component, tibial component and insert wedge) that can be combined one with each other depending on the anatomy of the patient. The cleared femoral components are available in three sizes (54mm, 64mm and 74mm). With this 510(k) submission. OsteoRemedies is adding the additional 84mm size (extra-large) to the FDA cleared range of Remedy Femoral Component.
The Remedy® Stemmed Knee Spacer is a temporary knee spacer device consisting of independent components (femoral component, tibial component and stem extension components) that can be combined one with each other depending on the anatomy of the patient. These components are available in different sizes to further accommodate variations in patient anatomy.
The Stem Extension Implant components can be coupled with both the femoral and the tibial components, as they are intended to be used, if necessary, to replace the space occupied by the previous femoral and/or tibial stem. The Remedy Stemmed Tibial component could also be coupled, if necessary, with the commercially marketed Remedy Tibial Insert Wedge (K112470), when a large tibial defect is present.
The Remedy Femoral Component 84mm and the Remedy Stemmed Knee Spacer are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacement. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque
6
and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liquid components. The liquid component consists of methylmethacrylate (MMA), N. N dimethyl-p-toluidine and hydroguinone; the powder component consists of PMMA, barium sulphate, benzovl peroxide and gentamicin sulphate. The stem components also present an inner core of Stainless Steel (AISI 316 ESR).
The devices (which consists of the combination of single components) provide patients a temporary complete knee implant that allows for a natural range of motion and partial weightbearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection. The devices are protected from bacterial adhesion due to the presence of gentamicin, similar to other spacers devices made with PMMA with antibiotics currently on the US market.
റ INDICATIONS FOR USE
Remedy® Femoral Component 84mm (Extra-Large)
The Remedy Knee Spacer, which consists of a Femoral Component, a Tibial Component and a Tibial Insert, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).
The device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the Tibial Insert is optional, when a large tibial defect is present.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The Remedy Knee Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrvlate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.
Remedy® Stemmed Knee Spacer
The Remedy Stemmed Knee Spacer, which consists of a modular femoral, tibial and stem extension components, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).
The device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the
7
stem extension component is optional to replace the space occupied by the previous femoral and/or tibial stem (dead space management). Moreover, if necessary, the tibial component could be coupled with the Osteoremedies Remedy Tibial Insert Wedge when a large tibial defect is present.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The Remedy Stemmed Knee Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrvlate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.
COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICES 6
The Remedy® Stemmed Knee Spacer, the Remedy® Femoral Component 84mm and the predicate device, the Remedy® Knee Spacer, are intended to be used in the same surgical procedure (two-stage revision procedure) in the same target patient population and have the same primary function of providing patients a temporary knee implant to allow for a natural range of motion and partial weight bearing. Thus, the Remedy® Femoral Component 84mm and the Remedy® Stemmed Knee Spacer have the same intended use as the predicate device. The Remedy® Stemmed Knee Spacer and the Remedy® Femoral Component 84mm also share the same intended use as the Tecres InterSpace Knee for the same reasons.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICES
Remedy® Femoral Component 84mm (Extra-Large)
The Remedy® Femoral Component 84mm shares many of the same technological characteristics with the predicate Remedy® Knee Spacer, including important considerations such as the same materials, same PMMA bone cement formulation including antibiotic concentration, and mechanical performances. The technological characteristics are the same between the proposed device and the predicate device (see Table 1). The Remedy® Femoral Component 84mm results in four available sizes for the spacer device similar to the Tecres InterSpace Knee in terms of available sizes.
8
| Characteristics | OsteoRemedies LLC
Remedy® Femoral
Component 84mm
(subject device) | OsteoRemedies LLC
Remedy® Femoral
Component 54mm, 64mm,
74mm (Predicate Device,
K112470) | Comparison |
|----------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------|
| Main Material
Components | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Same |
| Other Material
Components | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Same |
| Antibiotic | Gentamicin Sulphate | Gentamicin Sulphate | Same |
| Modularity | Femoral Component
Tibial Component
Tibial Insert Wedge (optional) | Femoral Component
Tibial Component
Tibial Insert Wedge
(optional) | Same |
| Femoral Component
Sizes | 84mm | 54mm, 64mm, 74mm | Different |
| X-ray Visibility | Yes | Yes | Same |
| Single-use Device | Yes | Yes | Same |
| Provided Sterile | Yes | Yes | Same |
| Spacer Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterility
Assurance
Level
(SAL)
Powder | 10-6 | 10-6 | Same |
| Shelf Life | 45 months | 60 months | Different |
Table 1: Summary of Technological Characteristics between the Remedy® Femoral Component 84mm and the Remedy® Femoral Component 54mm, 64mm, 74mm
Remedy® Stemmed Knee Spacer
The Remedy® Stemmed Knee Spacer shares many of the same technological characteristics compared to the predicate Remedy® Knee Spacer, including important considerations such as the same materials, same PMMA bone cement formulation including antibiotic concentration, and mechanical performances. The technological characteristics are the same between the proposed device and the predicate device (see Table 2).
9
| Characteristics | OsteoRemedies LLC
Remedy® Stemmed Knee
Spacer (Subject Device) | OsteoRemedies LLC
Remedy Knee Spacer
(Predicate Device, K112470) | Comparison |
|------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------|
| Main Material
Components | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Same |
| Other Material
Components | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Same |
| Antibiotic | Gentamicin Sulphate | Gentamicin Sulphate | Same |
| Inner core | Stem Extension: Stainless
Steel (AISI 316 ESR) | None | Different |
| Design (shape) | Femoral Component
Tibial Component
Stem Extension Components
(optional) | Femoral Component
Tibial Component
Tibial Insert Wedge (optional) | Different |
| Modularity and
Sizes | Femoral Component: 4 sizes
Tibial Component: 3 sizes
Stem Extension Component:
2 sizes | Femoral Component: 4 sizes*
Tibial Component: 3 sizes
Tibial Insert Wedge: 3 sizes | Different |
| X-ray Visibility | Yes | Yes | Same |
| Single-use Device | Yes | Yes | Same |
| Provided Sterile | Yes | Yes | Same |
| Spacer Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterility Assurance
Level (SAL) -
Powder | 10-6 | 10-6 | Same |
| Shelf Life | 45 months | 60 months | Different |
Table 2: Summary of Technological Characteristics between the Remedy® Stemmed Knee Spacer and the Predicate Device, the Remedy® Knee Spacer
*Includes the 84mm size requested for clearance in this submission.
PERFORMANCE DATA 8
This 510(k) notification provided performance data to establish the substantial equivalence of the Remedy® Femoral Component 84mm and of the Remedy® Stemmed Knee Spacer to the predicate device. The following is a summary of the performance data.
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established through stability studies. The sterilization complies with: UNI EN ISO 11135:2014; EC 1-2011 UNI EN ISO 11737-1:2006, UNI EN ISO 11737
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2:2010, UNI EN ISO 10993-7:2009, UNI EN 556-1:2002, EP current Edition. The sterilization cycle was validated to a sterility assurance level of 106. The shelf life of the Remedy Femoral Component 84mm and of the Remedy Stemmed Knee Spacer was established through realtime and accelerated aging studies. All demonstrate a shelf life of 45 months.
Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" have been taken into account to evaluate the biocompatibility of the device materials.
Performance Testing on the Remedy Femoral Component 84mm: Performance testing was performed to characterize the Remedy Femoral Component 84mm in comparison to the predicate Remedy Knee Spacer.
This testing included the evaluation of:
- the static performances of the resin (ISO 5833), ●
- the fatigue performances of the resin (ASTM F2118).
- the surface roughness (ISO 4287), ●
- the range of motion (ASTM F2083), ●
- the device wear (ISO 14243-1), and
- the antibiotic (gentamicin) elution testing.
The performance data demonstrate that the Remedy Femoral Component 84mm is substantially equivalent to the predicate device.
Performance Testing on the Remedy Stemmed Knee Spacer: Performance testing was performed to characterize the Remedy Stemmed Knee Spacer in comparison to the predicate Remedy Knee Spacer.
This testing included the evaluation of
- the static performances of the resin (ISO 5833). ●
- the fatigue performances of the resin (ASTM F2118), ●
- the surface roughness (ISO 4287), ●
- the tibial tray fatigue behavior (ASTM F1800). ●
- the fatigue behavior of the stem extensions,
- the range of motion (ASTM F2083), ●
- the device wear (ISO 14243-1), and ●
- the antibiotic (gentamicin) elution testing.
The performance data demonstrate that the Remedy Stemmed Knee Spacer is substantially equivalent to the predicate devices.