(148 days)
No reference devices were used in this submission.
No
The document describes a mechanical limb salvage system and does not mention any software, algorithms, or AI/ML capabilities. The performance data section explicitly states there are no technological differences from the predicate device, which is a traditional mechanical implant system.
Yes.
The device is used for reduction or relief of pain and/or improved function in patients with various degenerative joint diseases, deformities, and fractures, which falls under the definition of a therapeutic device.
No
The device description indicates that the ELEOS™ Limb Salvage System consists of components used in the reconstruction of the lower limb, acting as prosthetic implants. Its intended use is for the reduction or relief of pain and/or improved function, correction of deformities, and revision/treatment of fractures, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly lists physical components such as femoral heads, stems, and tibial assemblies, indicating it is a hardware-based medical device for surgical reconstruction.
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 parts of the lower limb (hip and knee) in skeletally mature patients with various conditions like arthritis, trauma, and oncology indications. This is a therapeutic device used in vivo (within the body).
- Device Description: The device description details physical components like femoral heads, stems, hinges, etc., which are implanted during surgery.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant used to replace or reconstruct bone and joint structures.
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, 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 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
KRO, JDI, JWH, 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, 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, patella. stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Knee, Lower Limb (proximal femur, distal femur, total femur, proximal tibia)
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)
No performance data is provided. A copy of the full 510(k) for the predicate device (K013035) is provided because there are no technological differences between the subject and predicate devices. Pyrogenicity was assessed using the LAL test which identified an acceptable endotoxin limit. Testing to monitor pyrogens will be performed using periodic testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K013035, K973524, K002149, K932222
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head, body, and legs.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
Onkos Surgical, Inc. Jan Triani Sr. Director Quality Assurance and Regulatory Affairs 77 East Halsey Road Parsippany, New Jersey 07054
Re: K161520
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, JDI, JWH, LPH, LZO Dated: September 28, 2016 Received: September 30, 2016
Dear Jan Triani:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161520
Device Name ELEOS LIMB SALVAGE SYSTEM
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:
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;
-
- 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
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
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4
5. 510(k) Summary
I. SUBMITTER
Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054
Phone: (201)543-9388
Contact Person: Jan Triani Email: jtriani@onkossurgical.com
Date Prepared: October 27, 2016
II. DEVICE
| Name of Device: | ELEOST™ Limb Salvage System |
|---|---|
| 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 | |
| Regulatory Class: | II |
| Product Code: | JDI/KRO |
| JWH | |
| LPH | |
| LZO |
III. PREDICATE DEVICE
GUARDIAN® Limb Salvage System, K013035 ADVANCE® Modular Tibial Component, K973524 LINEAGE® Acetabular System, K002149 SLT Femoral Heads, K932222
No reference devices were used in this submission.
5
IV. 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, 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, patella. stem extension, 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 | ✓ | ✓ | |||
| Mid-Section | ✓ | ✓ | ✓ | ✓ | |
| Segmental Stem | ✓ | ✓ | ✓ | ✓ | |
| Distal Femur | ✓ | ✓ | |||
| Tibial Hinge Component | ✓ | ✓ | ✓ | ✓ | |
| Axial Pin | ✓ | ✓ | ✓ | ✓ | |
| Tibial Poly Spacer | ✓ | ✓ | ✓ | ✓ | |
| Tibial Baseplate | ✓ | ✓ | ✓ | ✓ | |
| Male-Male Mid-Section | ✓ | ||||
| Resurfacing Hinge Femur | ✓ | ||||
| Proximal Tibia | ✓ | ||||
| Patella | ✓* | ✓* | ✓* | ✓* | |
| Wedges and Augments | ✓* | ✓* | ✓* | ✓* | |
| Stem Extension | ✓* | ✓* | ✓* | ✓* |
*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.
V. 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:
-
- 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:
6
Onkos Surgical, Inc. ELEOSTM Limb Salvage Systems
-
- 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;
-
- 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
VI. COMPARISON OF TECHNOLOGICAL CHARACTERSTICS WITH THE PREDICATE DEVICE
The predicate devices and the subject device are the same materials, technology and sterilization methods are used to manufacture the subject device. The predicate device manufacturer is the contract manufacturer of the subject device. There are no technological differences between the two systems.
VII.PERFORMANCE DATA
No performance data is provided. A copy of the full 510(k) for the predicate device (K013035) is provided because there are no technological differences between the subject and predicate devices. Pyrogenicity was assessed using the LAL test which identified an acceptable endotoxin limit. Testing to monitor pyrogens will be performed using periodic testing.
VIII. CONCLUSIONS
Since the subject device is identical with respect to fit. form. function and manufacturing processes as the predicate device, the ELEOS™ Limb Salvage System has the same safety and effectiveness profile as the predicate device.