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;

1. Inflammatory degenerative joint disease including rheumatoid arthritis;
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and
1. 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.

1. Metastatic diseases

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (ELEOS Limb Salvage System) seeking FDA clearance based on substantial equivalence to a predicate device. It does not describe a study involving acceptance criteria for a device's performance in the context of an AI/algorithm-driven system. Therefore, I cannot extract the information required to answer your questions as they pertain to AI/algorithm performance studies.

The document states:

"No performance data is provided." (Page 7, Section VII. Performance Data)
"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." (Page 7, Section VII. Performance Data)
The conclusion is based on the subject device being "identical with respect to fit, form, function and manufacturing processes as the predicate device" (Page 7, Section VIII. Conclusions).

This indicates that the clearance for the ELEOS Limb Salvage System was based on demonstrating substantial equivalence to a previously cleared device, not on independent performance testing against specific acceptance criteria for a new, AI-driven functionality.

Therefore, questions about acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this document.

Summary

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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.

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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

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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;

1. Inflammatory degenerative joint disease including rheumatoid arthritis;
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and
1. 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.

1. 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.

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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, Cemented21 CFR 888.3510, Prosthesis, Knee, Femorotibial,Constrained, Metal Polymer, Cemented21 CFR 888.3560, Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis.21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained,Metal/Polymer, Porous, Uncemented21 CFR 888.3353, Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer Cemented or Non-Porous, Uncemented
Regulatory Class:	II
Product Code:	JDI/KROJWHLPHLZO

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.

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IV. DEVICE DESCRIPTION

	RECONSTRUCTION APPLICATIONS
Components	ProximalFemur	DistalFemur	TotalFemur	ProximalTibia	HingedKnee
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:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia;
1. Inflammatory degenerative joint disease such as rheumatoid arthritis;
1. Correction of functional deformity
1. Revision procedures where other treatments or devices have failed; and,
1. 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:

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Onkos Surgical, Inc. ELEOSTM Limb Salvage Systems

1. Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;
1. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.
1. 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:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. Inflammatory degenerative joint disease including rheumatoid arthritis;
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and
1. 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:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
1. Surgical intervention for severe trauma. revision knee arthroplasties, and/or Oncology indications.
1. 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.

Regulation Number and Section

§ 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.