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.

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:

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

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (ELEOS Limb Salvage System with BioGrip) seeking FDA clearance. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets those criteria in the way you've outlined for a clinical performance study of, for example, an AI algorithm.

Instead, the document details performance data provided in support of substantial equivalence to a predicate device. This data focuses on mechanical and biocompatibility testing to ensure the new device (a line extension with modular collars and porous technology) is as safe and effective as the existing, cleared predicate device.

Here's a breakdown of what is available based on your request, with an explanation of why other points are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there isn't a direct "acceptance criteria" table with specific performance metrics (like sensitivity/specificity for an AI algorithm) that the device must meet to prove its clinical utility. Instead, the performance data provided demonstrates that the device performs similarly or better mechanically and is biocompatible compared to predicate devices, adhering to recognized standards.

Biocompatibility Testing:

Acceptance Criteria (General Goal)	Reported Device Performance
Biocompatible for permanent contact	Passed tests per ISO 10993 series and ANSI/AAMI ST72 for bacterial endotoxins.
Endotoxin levels within limits	Met 20 endotoxin units (EU)/device limit for implanted medical devices.

Mechanical Testing:

Acceptance Criteria (General Goal)	Reported Device Performance
Equivalent mechanical properties to predicate	Completed testing according to ASTM F1044, F1147, F1160, F1854, F1978, ISO 7206-4, and ISO 13179-1:2014. Results support substantial equivalence to predicate.
Adequate strength and durability	Implicitly demonstrated by passing the listed ASTM and ISO standards for orthopedic implants. The specific numerical results (e.g., shear strength values) are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in the context of this 510(k) submission. The "test set" in this case refers to the physical device components subjected to laboratory testing. The document does not describe a clinical study with patients or data from medical records.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not established for the mechanical and biocompatibility tests performed. These tests rely on standardized protocols and measurements, not expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretations of data. The performance analyses presented here are laboratory-based.

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

This information is not applicable. This submission is for a physical orthopedic implant system, not an AI algorithm. No MRMC study or AI assistance is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This submission is for a physical orthopedic implant system, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the "ground truth" is defined by the toxicological characteristics and cellular responses measured against established ISO standards.
For mechanical testing, the "ground truth" is defined by the physical limits and properties established in the ASTM and ISO standards for orthopedic implants.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device's development as it is not an AI/machine learning device. The design and testing are based on engineering principles and material science.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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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

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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

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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.

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:

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)

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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:

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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, Cemented21 CFR 888.3510, Prosthesis, Knee, Femorotibial, Constrained,Metal Polymer, Cemented21 CFR 888.3560, Knee joint patellofemorotibialpolymer/metal/polymer semi- constrained cemented prosthesis21 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, Uncemented21 CFR 888.3390 Hip joint femoral (hemi-hip) metal/polymercemented 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)

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Device Description 5.4.

	RECONSTRUCTION APPLICATIONS
Components	ProximalFemur	DistalFemur	TotalFemur	ProximalTibia	HingedKnee
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:

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Premarket Notification: ELEOSTM Limb Salvage System with BioGrip™

1. 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)
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:

1. 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.
1. 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:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis.or avascular necrosis:
Inflammatory degenerative joint disease including rheumatoid arthritis; 2)
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;
Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology 2) indications.
1. 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.

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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<161>, 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

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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.

Regulation Number and Section

§ 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.