ELEOS Limb Salvage System featuring BIOGRIP

• K Number: K203090
• Device Name: ELEOS Limb Salvage System featuring BIOGRIP
• Manufacturer: Onkos Surgical
• Date Cleared: 2020-12-11 ( 59 days)
• Product Code: JDI JWH KRO LPH LZO
• Regulation Number: 888.3350

Intended 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: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia: 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity 4) Revision procedures where other treatments or devices have failed; and, 5) 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; 2) Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) 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; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and 5) 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: 1) Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. - 3) 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.

Predicate Devices

K161520

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical implant system for limb salvage and joint replacement. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on biocompatibility and mechanical testing.

Therapeutic

Yes.
The device is indicated for conditions such as reduction or relief of pain, improved hip/knee function, correction of functional deformity, and treatment of fractures, which are all therapeutic aims.

Diagnostic

No
The device, ELEOS Limb Salvage System, is indicated for use in total hip and knee arthroplasty for reconstruction of the lower limb, not for diagnosing conditions. It is a surgical implant.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components (femoral head, proximal femur, etc.) which are hardware used in surgical reconstruction. The performance studies also mention mechanical testing, further indicating a hardware device.

IVD (In Vitro Diagnostic)

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 (hip and knee) in patients with various conditions like degenerative joint disease, trauma, and oncology indications. This is a therapeutic device used in vivo (within the body).
• Device Description: The device description details components of a surgical implant (femoral head, stems, hinges, etc.) designed to be implanted into the body.
• 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 samples and provide diagnostic information. This device is a surgical implant used in vivo for treatment and reconstruction.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia:

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. 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;

2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.

3. 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;

2. Inflammatory degenerative joint disease including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and

5. 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:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.

3. Metastatic diseases

Product codes (comma separated list FDA assigned to the subject device)

JDI, KRO, 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, 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.

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

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)

The following performance data were provided in support of substantial equivalence:

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 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, Sensitization, Irritation, Systemic Toxicity: Acute, Systemic Toxicity: Material Mediated Pyrogenicity, Genotoxicity, Chemical Characterization, Toxicological Risk Assessment. 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, Medical Devices - Bacterial Endotoxin and Pyrogen Tests. Testing to monitor pyrogens will be performed periodically.

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, ASTM F1147, ASTM F1160, ASTM F1854, ASTM F1978, ASTM F2083, ISO13179-1:2014.

3. Clinical Data: Clinical data was not deemed necessary for the subject device.

4. 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.

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.

K161520

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.

Not Found

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

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.

Summary

0

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

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 ([e-mail]) or phone [phone] 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

2

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:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia:

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. 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;

2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.

3. 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;

2. Inflammatory degenerative joint disease including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and

5. 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:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.

• 3. 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: [phone] Contact Person: Matthew Vernak Email: [e-mail]

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, 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(s):	JDI KRO JWH LPH LZO

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

Device Description 5.4.

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.

Onkos Surgical, Inc.

5

K203090 Page 2 of 5

Premarket Notification: ELEOS™ Limb Salvage System with BIOGRIPTM

Components	RECONSTRUCTION APPLICATIONS
	Proximal
Femur	Distal
Femur	Total
Femur	Proximal
Tibia	Hinged
Knee
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;
• 2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. Correction of functional deformity
• 4. Revision procedures where other treatments or devices have failed; and,
• 5. 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.

6

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;
• 2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.
• 3. 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)
• 4. Revision procedures where other treatments or devices have failed; and
• 5. 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.
• 3. 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.

7

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, 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

8

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.