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.

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, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male-male mid-section, resurfacing hinge femur, and proximal tibia, patella, stem extension, modular collar, tibial wedges and augments.

AI/ML Overview

The ELEOS™ Limb Salvage System with BIOGRIP™ did not have specific quantitative acceptance criteria for performance metrics in a clinical or AI-assisted context. The substantial equivalence determination was based on demonstrating the safety and effectiveness of the device through biocompatibility and mechanical testing, comparing it to a predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 standards and FDA guidance for: - Cytotoxicity - Sensitization - Irritation - Acute Systemic Toxicity - Material Mediated Pyrogenicity - Genotoxicity - Chemical Characterization - Toxicological Risk Assessment - Endotoxin limit of 20 EU/device	"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." "The following biocompatibility tests were performed on each material group to ensure biocompatibility." (Implies successful completion for all listed tests).
Mechanical Performance	Equivalence to predicate device based on bench tests per FDA guidance and ASTM/ISO standards: - Shear Testing of Coatings (ASTM F1044) - Tension Testing of Coatings (ASTM F1147) - Shear and Bending Fatigue Testing of Coatings (ASTM F1160) - Stereological Evaluation of Porous Coatings (ASTM F1854) - Abrasion Resistance (ASTM F1978) - Knee Replacement Prosthesis Specification (ASTM F2083) - Plasma sprayed unalloyed titanium coatings (ISO13179-1:2014)	"The following bench testing was completed and the results of support the subject devices are equivalent to the predicate device." (Implies successful demonstration of equivalence across all listed tests).
Design Validation	Function as intended and user needs met.	"Design Validation demonstrated the subject implant and existing instruments function as intended and user needs were met."

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

Sample Size: Not applicable in the context of clinical testing with human subjects. The testing was primarily bench testing (biocompatibility and mechanical) and a cadaver lab for design validation. The document does not specify the number of individual test articles or specimens used in the bench tests, only the types of tests performed.
Data Provenance: The biocompatibility and mechanical testing were conducted in a laboratory setting (bench tests), not from patient data. The design validation used a cadaver lab.

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

Not applicable as the study did not involve human experts establishing ground truth on a test set (e.g., image interpretation for an AI device). The "ground truth" for the performance aspects was established through standardized laboratory testing protocols and design validation in a cadaver lab.

4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)

Not applicable. There was no expert adjudication process for a test set as the evaluation was based on laboratory testing and functional assessment in a cadaver lab rather than diagnostic interpretation.

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

No, an MRMC comparative effectiveness study was not done. This device is a medical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical medical implant (Limb Salvage System), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating the device's acceptable performance was based on:
- Validated laboratory testing standards (ISO and ASTM for biocompatibility and mechanical properties)
- Direct functional assessment in a cadaver lab for design validation.
- Comparison to a legally marketed predicate device to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes the clearance of a medical device (implant), not an AI algorithm that requires a training set.

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

Not applicable. As there was no AI algorithm or training set, there was no ground truth for a training set to be established.

Summary

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December 11, 2020

Image /page/0/Picture/1 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Onkos Surgical Matthew (Matt) Vernak Vice President, Quality, Regulatory, and Product Development 77 East Halsey Rd Parsippany, New Jersey 07054

Re: K203090

Trade/Device Name: ELEOS™ Limb Salvage System featuring 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 Dated: October 13, 2020 Received: October 13, 2020

Dear Matthew (Matt) 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

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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,

Ting Song, Ph.D., R.A.C. 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

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Indications for Use

510(k) Number (if known) K203090

Device Name

ELEOS™ Limb Salvage System with BIOGRIP™

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.

1. Metastatic diseases
  Type of Use (Select one or both, as applicable)

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.

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K203090 Page 1 of 5

Premarket Notification: ELEOS™ Limb Salvage System with BIOGRIP™

5. 510(k) Summary

Submitter 5.1.

Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054 Phone: (551) 579-1081 Contact Person: Matthew Vernak Email: mvernak@onkossurgical.com

Date Prepared: 11-Oct-2020

5.2. Device

Name of Device:	ELEOST™ 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 patellofemorotibial polymer/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, Uncemented
Regulatory Class:	II
Product Code(s):	JDI KRO JWH LPH LZO

Predicate Device 5.3.
ELEOS™ Limb Salvage System, Onkos Surgical, Inc., K161520

Device Description 5.4.

Onkos Surgical, Inc.

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K203090 Page 2 of 5

Premarket Notification: ELEOS™ Limb Salvage System with BIOGRIPTM

Components	RECONSTRUCTION APPLICATIONS
	ProximalFemur	DistalFemur	TotalFemur	ProximalTibia	HingedKnee
Femoral head	✓		✓
Proximal Femur	✓		✓
Mid-Section	✓	✓	✓	✓
Segmental Stem	✓	✓	✓	✓
Modular Collar	✓	✓	✓	✓
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		✓	✓	✓	✓

Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.

1 - Bolded components are offered with BIOGRIP™ porous technology.

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.

Indications for Use 5.5.

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:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascularnecrosis, 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:

Onkos Surgical, Inc.

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K203090 Page 3 of 5

Premarket Notification: ELEOS™ Limb Salvage System with BIOGRIP™

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 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)
Correction of functional deformity; 3)
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

Comparison of Technological Characteristics with the Predicate Device 5.6.

The primary difference between the subject implant, which is a line extension to the predicate device system, is the manufacturing process used. Specifically, an additive manufacturing processes is used to create the ELEOS BIOGRIP™ Proximal Tibia. The implant incorporates an additive porous surface (replacing titanium plasma) and additional suture holes are incorporated to better facilitate approximation of soft tissue and support bony apposition. Mechanical (both static and fatigue) and biocompatibility testing have demonstrated that the subjected device is substantially equivalent to the predicate system.

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 BIOGRIP™ Proximal Tibia 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

Onkos Surgical, Inc.

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K203090 Page 4 of 5

Premarket Notification: ELEOS™ Limb Salvage System with BIOGRIP™

Risk Management Process" issued June 16, 2016. The subject device is a permanent contact device manufactured from printed Ti6A14V. 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 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

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K203090 Page 5 of 5

Premarket Notification: ELEOS™ Limb Salvage System with BIOGRIPTM

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
ASTM F2083, Standard Specification for Knee Replacement Prosthesis
ISO13179-1:2014: Implants for surgery - Plasma sprayed unalloyed titanium coatings on metallic surgical implants

Clinical Data 5.8

Clinical data was not deemed necessary for the subject device.

5.9 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 5.10

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. 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.