(162 days)
No
The summary does not mention AI, ML, or any related technologies in the intended use, device description, or performance studies. The device appears to be a traditional mechanical implant system.
Yes
The device is indicated for conditions such as pain relief, improved function, and correction of functional deformity, which are all therapeutic outcomes. It is used in total hip and knee arthroplasty to treat various degenerative joint diseases, fractures, and for reconstruction after radical resection.
No
The ELEOS™ Limb Salvage System is described as a system for the reconstruction of the lower limb, indicated for use in total hip and knee arthroplasty for conditions such as degenerative joint disease, correction of functional deformity, revision procedures, and treatment of fractures. This indicates its use as a therapeutic or restorative device, not for diagnosing medical conditions.
No
The device description explicitly lists physical components such as femoral heads, stems, tibial assemblies, and instrumentation, indicating it is a hardware-based medical device used for surgical reconstruction.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The ELEOS™ Limb Salvage System is described as a system of components used for the surgical reconstruction of the lower limb (femur and tibia). These are implants designed to be placed inside the body.
- Intended Use: The intended use clearly states that the system is for total hip and knee arthroplasty and limb salvage procedures to reduce pain, improve function, and treat various conditions affecting the bones and joints. This is a surgical intervention, not a diagnostic test performed on specimens.
The information provided describes a surgical implant system, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
ELEOS™ Limb Salvage System Hip Components:
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions :
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed; and,
- Treatment of fractures that are unmanageable using other techniques.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and or total femur is required with the following conditions:
- Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment:
- Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.
- Metastatic diseases
ELEOS™ Limb Salvage System Knee Components:
Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Treatment of fractures that are unmanageable using other techniques.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:
- Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
- Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.
- Metastatic diseases
Product codes
JDI, KRO, JWH, LPH, LZO, KWY
Device Description
The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, optional components include modular collars, patella, stem extensions, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.
The implants are single use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower limb (proximal femur, distal femur, total femur, proximal tibia, hinged 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:
5.7.1 Biocompatibility: Evaluation 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" issued June 16, 2016. Tests performed on printed Ti6Al4V material: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity (Acute and Material Mediated Pyrogenicity), Genotoxicity, Chemical Characterization, Toxicological Risk Assessment. Bacterial endotoxin test performed to verify meeting 20 endotoxin units (EU)/device pyrogen limit specification.
5.7.2. Mechanical Testing: Bench tests selected based on FDA Guidance: "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", Issued 28-Apr-1994. Tests completed: ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1854, ASTM F1978, ISO 7206-4, ISO 13179-1:2014. Results supported substantial equivalence.
Clinical Data:
Clinical data was not deemed necessary for the subject device.
Design Validation:
Design Validation was performed for the subject implant using a cadaver lab. Design Validation demonstrated the subject implant and existing instruments function as intended and user needs were met.
Key results: Based on test results and supporting documentation, the subject ELEOS Limb Salvage System with BioGrip™ is substantially equivalent to the predicate device, ELEOS Limb Salvage System with BioGrip™. Differences do not raise new questions of safety and effectiveness, and the proposed device is at least as safe and effective as the legally marketed predicate device.
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.
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.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
June 9, 2021
Image /page/0/Picture/1 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Onkos Surgical Matthew Vernak Vice President, Quality, Regulatory, and Product Development 77 East Halsey Rd Parsippany, New Jersey 07054
Re: K203815
Trade/Device Name: ELEOS Limb Salvage System with BioGrip Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, KRO, JWH, LPH, LZO, KWY Dated: May 12, 2021 Received: May 13, 2021
Dear Matthew Vernak:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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,
For:
William Jung, PhD 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
2
Indications for Use Statement (Form FDA 3881) 4.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
203815
Device Name ELEOSTM Limb Salvage System with BioGrip™
Indications for Use (Describe)
ELEOSTM Limb Salvage System Hip Components:
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions :
-
Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia;
-
Inflammatory degenerative joint disease such as rheumatoid arthritis;
-
Correction of functional deformity
-
Revision procedures where other treatments or devices have failed; and,
-
Treatment of fractures that are unmanageable using other techniques.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and or total femur is required with the following conditions:
-
Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment:
-
Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.
-
- Metastatic diseases
ELEOSTM Limb Salvage System Knee Components:
- Metastatic diseases
Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
-
Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;
-
Inflammatory degenerative joint disease including rheumatoid arthritis;
-
Correction of functional deformity;
-
Revision procedures where other treatments or devices have failed; and
-
Treatment of fractures that are unmanageable using other techniques.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:
-
Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
-
Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.
-
Metastatic diseases
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.
FORM FDA 3881 (6/20)
3
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
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FORM FDA 3881 (6/20)
Page 2 of 2
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K203815 p.1/5
ડ. 510(k) Summary
રું ! . Submitter
Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054 Phone: (551) 579-1081 Contact Person: Matthew Vernak Email: mvernak(@onkossurgical.com
Date Prepared: 08-Jun-2021
5.2. Device
| Name of Device: | ELEOSTM Limb Salvage System with BioGrip™ |
|---|---|
| Common Name: | Limb Salvage System |
| Classification Name: | 21 CFR 888.3350, Prosthesis, Hip, Semi-Constrained, |
| Metal/Polymer, Cemented | |
| 21 CFR 888.3510, Prosthesis, Knee, Femorotibial, Constrained, | |
| Metal Polymer, Cemented | |
| 21 CFR 888.3560, Knee joint patellofemorotibial | |
| polymer/metal/polymer semi- constrained cemented prosthesis | |
| 21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained, | |
| Metal/Polymer, Porous, Uncemented | |
| 21 CFR 888.3353, Prosthesis, Hip, Semi-Constrained, | |
| Metal/Ceramic/Polymer Cemented or Non-Porous, Uncemented | |
| 21 CFR 888.3390 Hip joint femoral (hemi-hip) metal/polymer | |
| cemented or uncemented prosthesis | |
| Regulatory Class: | II |
JDI KRO JWH LPH LZO KWY Product Code(s):
Predicate and Reference Devices 5.3.
ELEOS™ Limb Salvage System with BioGrip™, Onkos Surgical, Inc., K203090 (Predicate Device)
ELEOS™ Limb Salvage System, Onkos Surgical, Inc., K161520 (Predicate Device) Modular Endoprosthetic Tumour System (METS), Stanmore, K121029 (Reference Device) Modular Endoprosthetic Tumour System (METS), Stanmore, K121056 (Reference Device)
5
Device Description 5.4.
The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, optional components include modular collars, patella, stem extensions, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.
| RECONSTRUCTION APPLICATIONS | |||||
|---|---|---|---|---|---|
| Components | Proximal | ||||
| Femur | Distal | ||||
| Femur | Total | ||||
| Femur | Proximal | ||||
| Tibia | Hinged | ||||
| Knee | |||||
| Femoral head | ✓ | ✓ | |||
| Proximal Femur | ✓ | ✓ | |||
| Mid-Section | ✓ | ✓ | ✓ | ✓ | |
| Segmental Stem | ✓ | ✓ | ✓ | ✓ | |
| Modular Collar1, 2 | ✓ | ✓ | ✓ | ||
| Distal Femur | ✓ | ✓ | ✓ | ||
| Tibial Hinge Component | ✓ | ✓ | ✓ | ✓ | |
| Axial Pin | ✓ | ✓ | ✓ | ✓ | |
| Tibial Poly Spacer | ✓ | ✓ | ✓ | ✓ | |
| Tibial Baseplate | ✓ | ✓ | ✓ | ✓ | |
| Male-Male Mid-Section | ✓ | ✓ | |||
| Resurfacing Hinge Femur | ✓ | ✓ | |||
| Proximal Tibia1 | ✓ | ||||
| Patella2 | ✓ | ✓ | ✓ | ✓ | |
| Wedges and Augments2 | ✓ | ✓ | ✓ | ✓ | |
| Stem Extensions2 | ✓ | ✓ | ✓ | ✓ |
1 - Bolded components are offered with BioGrip™ porous technology. Porous modular collars are offered with or without HA treatment.
2 - These implants are optional for each procedure. The surgeon shall use his/her medical judgement to determine if these implants are necessary based on factor such as patient bone quality, joint stability and pathology.
The implants are single use devices.
5.5. Indications for Use
ELEOSTM Limb Salvage System Hip Components:
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
6
Premarket Notification: ELEOSTM Limb Salvage System with BioGrip™
-
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascularnecrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis; 2)
-
- Correction of functional deformity
-
- Revision procedures where other treatments or devices have failed; and,
-
- Treatment of fractures that are unmanageable using other techniques.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/or total femur is required with the following conditions:
-
- Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;
- Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology 2) indications.
-
- Metastatic diseases
ELEOSTM Limb Salvage System with Knee Components:
Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
-
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis.or avascular necrosis:
- Inflammatory degenerative joint disease including rheumatoid arthritis; 2)
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed; and
-
- Treatment of fractures that are unmanageable using other techniques.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:
-
- Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
- Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology 2) indications.
-
- Metastatic diseases
5.6. Comparison of Technological Characteristics with the Predicate Device
The primary difference between the subject device, which is a line extension to the predicate device, is the provision of modular collars to match patient anatomy. Specifically, the stems have been modified to accept porous or solid modular collars. The porous collars are produced using an additive manufacturing process with the option to be treated with a nano HA surface treatment. The implant incorporates a hybrid stem and a modular collar with or without HA. Mechanical (both static and fatigue) and biocompatibility testing have demonstrated that the subjected device is substantially equivalent to the predicate system. Furthermore, the technological characteristic of a modular collar has been cleared with Stanmore's METS,
Onkos Surgical, Inc.
7
reference K121029 and K121056.
5.7. Performance Data
The following performance data were provided in support of substantial equivalence:
5.7.1 Biocompatibility
The biocompatibility evaluation for the ELEOS Limb Salvage System with BioGrip™ 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" issued June 16, 2016. The subject device is a permanent contact device manufactured from printed Ti6Al4V. The following biocompatibility tests were performed on each material group to ensure biocompatibility:
- Cytotoxicity (per ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- Sensitization (per ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- Irritation (per ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- . Systemic Toxicity: Acute (per ISO 10993-11, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity)
- Systemic Toxicity: Material Mediated Pyrogenicity (per ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity, and ST72:2011/(R)2016, Bacterial endotoxins - Test methods routine monitoring and alternatives to batch testing)
- Genotoxicity (per ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity)
- Chemical Characterization (per ISO 10993-18, Biological evaluation of medical devices -Part 18: Chemical characterization of medical device materials within a risk management process)
- Toxicological Risk Assessment (per ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances)
The bacterial endotoxin test was performed to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed, and it was confirmed that the subject devices meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72: Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing and USP, Medical Devices -Bacterial Endotoxin and Pyrogen Tests. Testing to monitor pyrogens will be performed periodically.
5.7.2. Mechanical Testing
Onkos Surgical has evaluated the subject devices to demonstrate substantial equivalence to the
8
predicate devices. The following FDA Guidance documents were consulted to select the bench tests:
-
. FDA Guidance: "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", Issued 28-Apr-1994
The following bench testing was completed and the results of support the subject devices are equivalent to the predicate device: -
ASTM F1044 - Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
-
ASTM F1147 - Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
-
ASTM F1160: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
-
ASTM F1854 - Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
-
ASTM F1978 - Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
-
ISO 7206-4 Implants for surgery Partial and total hip joint prostheses Part 4: ● Determination of endurance properties and performance of stemmed femoral components
-
. ISO 13179-1:2014: Implants for surgery - Plasma sprayed unalloyed titanium coatings on metallic surgical implants
5.8 Clinical Data
Clinical data was not deemed necessary for the subject device.
રું તે Design Validation
Design Validation was performed for the subject implant using a cadaver lab. Design Validation demonstrated the subject implant and existing instruments function as intended and user needs were met.
Conclusions રું 10
Based on the test results and supporting documentation provided in this premarket notification, the subject ELEOS Limb Salvage System with BioGrip™ is substantially equivalent to the predicate device, ELEOS Limb Salvage System with BioGrip™. The content in this premarket notification demonstrates that:
- any differences do not raise new questions of safety and effectiveness;
- and the proposed device is at least as safe and effective as the legally marketed predicate device.