(59 days)
No
The 510(k) summary describes a mechanical implant system and associated instrumentation. There is no mention of software, algorithms, image processing, AI, or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for conditions such as pain relief, improved function, and correction of functional deformity, which are therapeutic outcomes.
No
The device is described as a limb salvage system used for reconstruction in total hip and knee arthroplasty, and its indications for use involve treating existing conditions or failures, not diagnosing them.
No
The device description explicitly lists numerous physical components (femoral head, proximal femur, mid-section, stem, etc.) and mentions instrumentation provided in surgical trays, indicating it is a hardware-based medical device.
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 surgical implant system for reconstructing the lower limb in patients with various conditions affecting the hip and knee. This is a therapeutic device used in vivo (within the body).
- Device Description: The device description lists components of a surgical implant (femoral head, stems, spacers, etc.) and associated instrumentation. These are physical components implanted during surgery.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
ELEOS™ Limb Salvage System with 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 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:
l ) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 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 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 (comma separated list FDA assigned to the subject device)
KRO, JWH, JDI, LPH, LZO
Device Description
The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications 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 femur, tibial hinge component, axial pin, tibial poly spacer, tibial baseplate, male-male mid-section, resurfacing femur, proximal tibia, tapered screws, patella, stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.
1 - The Resurfacing Femur and Tibial Baseplate have the option for addition of a tapered screw between the respective component and a stem extension. The surgeon shall use their medical judgement to determine if the additional fixation is necessary based on factors such as patient bone quality, joint stability, and pathology.
2 - These implants are optional for each procedure. The surgeon shall use their 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Knee, proximal femur, distal femur, total femur, proximal tibia
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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.
The following performance data are provided in support of substantial equivalence:
5.7.1 Mechanical Testing
Onkos Surgical has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. The following bench testing was completed and the results of support the subject devices are equivalent to the predicate device:
- Fatigue testing per ASTM F1800, Standard Practice for Cyclic Fatigue Testing of Metal ● Tibial Tray Components of Total Knee Joint Replacements and ASTM F2083, Standard Specification for Knee Replacement Prosthesis
- Evaluation of fretting corrosion for mating surfaces post fatigue testing
- Evaluation of screw loosening post fatigue testing
5.8 Clinical Data
Clinical data was not deemed necessary for the subject 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
February 5, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
Onkos Surgical Matthew Vernak Vice President, Quality, Regulatory and Product Development 77 East Halsey Rd Parsippany, New Jersey 07054
Re: K203588
Trade/Device Name: ELEOS™ Limb Salvage System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, JWH, JDI, LPH, LZO Dated: December 8, 2020 Received: December 8, 2020
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
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/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,
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203588
Device Name ELEOSTM Limb Salvage System
Indications for Use (Describe)
ELEOSTM Limb Salvage System with 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 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:
l ) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 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 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)
- Metastatic diseases
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.
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
"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
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: 04-Feb-2021
| Name of Device: | ELEOST™ Limb Salvage System |
|---|---|
| Common Name: | Limb Salvage System |
| Classification Name: | 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 888.3350, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 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 |
| Regulatory Class: | II |
| Product Code(s): | KRO JWH JDI LPH LZO |
- Predicate Device 5.3.
ELEOSTM Limb Salvage System, Onkos Surgical, Inc., K161520 (Predicate) Orthopaedic Salvage System (OSS), Biomet, K052685 (Reference Device)
5.4. Device Description
The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications 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 femur, tibial hinge component, axial pin, tibial poly spacer, tibial baseplate, male-male mid-section, resurfacing femur, proximal tibia,
5
| Components | RECONSTRUCTION APPLICATIONS | ||||
|---|---|---|---|---|---|
| Proximal | |||||
| Femur | Distal | ||||
| Femur | Total | ||||
| Femur | Proximal | ||||
| Tibia | Hinged | ||||
| Knee | |||||
| Femoral head | ✓ | ✓ | |||
| Proximal Femur | ✓ | ✓ | |||
| Mid-Section | ✓ | ✓ | ✓ | ✓ | |
| Segmental Stem | ✓ | ✓ | ✓ | ✓ | |
| Distal Femur | ✓ | ✓ | |||
| Tibial Hinge Component | ✓ | ✓ | ✓ | ✓ | |
| Axial Pin | ✓ | ✓ | ✓ | ✓ | |
| Tibial Poly Spacer | ✓ | ✓ | ✓ | ✓ | |
| Tibial Baseplate1 | ✓ | ✓ | ✓ | ✓ | |
| Male-Male Mid-Section | ✓ | ||||
| Resurfacing Femur1 | ✓ | ✓ | |||
| Proximal Tibia | ✓ | ||||
| Tapered Screws1 | ✓ | ✓ | ✓ | ✓ | |
| Patella2 | ✓ | ✓ | ✓ | ||
| Wedges and Augments2 | ✓ | ✓ | ✓ | ||
| Stem Extensions2 | ✓ | ✓ | ✓ | ✓ |
tapered screws, patella, stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.
1 - The Resurfacing Femur and Tibial Baseplate have the option for addition of a tapered screw between the respective component and a stem extension. The surgeon shall use their medical judgement to determine if the additional fixation is necessary based on factors such as patient bone quality, joint stability, and pathology.
2 - These implants are optional for each procedure. The surgeon shall use their 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.
ર . ર. .
રાજ્યના સાંદર્શાય તેમ જ દૂધની ડેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ Indications for Use
ELEOSTM Limb Salvage System with 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:
- l) 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,
6
-
- 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:
- Treatment of fractures that are unmanageable using other techniques.
-
- 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:
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 4)
- Treatment of fractures that are unmanageable using other techniques. న)
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
5.6. Comparison of Technological Characteristics with the Predicate Device
The primary difference between the subject device and the predicate device is the option to use a tapered screw between the resurfacing femur and tibial baseplate components and corresponding stem extension. The tapered screw will be manufactured from Titanium-6Aluminum-4Vanadium (TAV) ELI per ASTM F136 and offered in two sizes (0.650" for use with the tibial baseplate and 1" for use with the resurfacing femur). To accommodate the screw, the resurfacing femur was modified to remove material between the condyles to allow insertion of a tapered screw between the resurfacing femur and stem extension after impaction of the tapered connections. This modification was incorporated as not to affect any of the bearing surfaces. Additionally, a tapered hole was incorporated into the sleeve of the tibial baseplate to allow insertion of a tapered screw between the tibial baseplate and stem extension after impaction of the tapered connections.
7
Performance Data 5.7.
The following performance data are provided in support of substantial equivalence:
5.7.1 Mechanical Testing
Onkos Surgical has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. The following bench testing was completed and the results of support the subject devices are equivalent to the predicate device:
- Fatigue testing per ASTM F1800, Standard Practice for Cyclic Fatigue Testing of Metal ● Tibial Tray Components of Total Knee Joint Replacements and ASTM F2083, Standard Specification for Knee Replacement Prosthesis
- Evaluation of fretting corrosion for mating surfaces post fatigue testing
- Evaluation of screw loosening post fatigue testing
5.8 Clinical Data
Clinical data was not deemed necessary for the subject device.
ર .9 Conclusions
Based on the test results and supporting documentation provided in this premarket notification, the subject ELEOS Limb Salvage System is substantially equivalent to the predicate, ELEOS Limb Salvage System. 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.