(267 days)
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.
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.
The provided text describes the 510(k) premarket notification for the "Remedy® Femoral Component 84mm" and the "Remedy® Stemmed Knee Spacer". This documentation focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where a device's performance is measured against predefined acceptance criteria in the context of diagnostic accuracy or clinical outcomes.
Therefore, many of the requested elements (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size) are not applicable or mentioned in this type of regulatory submission.
However, I can extract the relevant information regarding performance testing that was conducted to support their claim of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in a table format for each test, but it states that the performance data demonstrates substantial equivalence to the predicate device. The performance tests are primarily engineering and material science tests.
| Characteristic Tested | Test Standard/Method | Outcome/Performance Reported |
|---|---|---|
| Sterilization | 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 | Validated to a sterility assurance level (SAL) of 10^-6 |
| Shelf Life | Real-time and accelerated aging studies | Established for 45 months |
| Biocompatibility | ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993..." | Device materials are "safe, biocompatible and suitable for their intended use" |
| Remedy® Femoral Component 84mm: | ||
| Static Performances (of resin) | ISO 5833 | Performance data demonstrates substantial equivalence to predicate device. |
| Fatigue Performances (of resin) | ASTM F2118 | Performance data demonstrates substantial equivalence to predicate device. |
| Surface Roughness | ISO 4287 | Performance data demonstrates substantial equivalence to predicate device. |
| Range of Motion | ASTM F2083 | Performance data demonstrates substantial equivalence to predicate device. |
| Device Wear | ISO 14243-1 | Performance data demonstrates substantial equivalence to predicate device. |
| Antibiotic Elution | Not specified (Gentamicin) | Performance data demonstrates substantial equivalence to predicate device. |
| Remedy® Stemmed Knee Spacer: | ||
| Static Performances (of resin) | ISO 5833 | Performance data demonstrates substantial equivalence to predicate device. |
| Fatigue Performances (of resin) | ASTM F2118 | Performance data demonstrates substantial equivalence to predicate device. |
| Surface Roughness | ISO 4287 | Performance data demonstrates substantial equivalence to predicate device. |
| Tibial Tray Fatigue Behavior | ASTM F1800 | Performance data demonstrates substantial equivalence to predicate device. |
| Fatigue Behavior (of stem extensions) | Not specified | Performance data demonstrates substantial equivalence to predicate device. |
| Range of Motion | ASTM F2083 | Performance data demonstrates substantial equivalence to predicate device. |
| Device Wear | ISO 14243-1 | Performance data demonstrates substantial equivalence to predicate device. |
| Antibiotic Elution | Not specified (Gentamicin) | Performance data demonstrates substantial equivalence to predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify sample sizes (e.g., number of units tested) for the engineering and material performance tests. The tests are benchtop, in-vitro experiments, so data provenance in terms of country of origin or retrospective/prospective clinical data is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for these types of mechanical and material tests is established by adherence to documented international and national standards (ISO, ASTM) and the results obtained from those tests, not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically associated with clinical studies or diagnostic accuracy assessments, not with the type of engineering performance tests described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/diagnostic device, and no MRMC study or assessment of human reader improvement is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a temporary knee spacer, a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance data in this context is based on established engineering and material science standards (e.g., ISO, ASTM) and the objective measurements derived from testing the device against those standards. For biocompatibility, it relied on ISO 10993 and FDA guidance.
8. The sample size for the training set
Not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.