ELEOS™ Bipolar Acetabular System

K180130 · Onkos Surgical, Inc. · KWY · Feb 23, 2018 · Orthopedic

Device Facts

• Record ID: K180130
• Device Name: ELEOS™ Bipolar Acetabular System
• Applicant: Onkos Surgical, Inc.
• Product Code: KWY · Orthopedic
• Decision Date: Feb 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ELEOSTM Bipolar Acetabular System is indicated for the following conditions: 1) pathological fractures of the femoral neck 2) non-union of femoral neck fractures 3) aseptic necrosis of the femoral head and neck 4) primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

Device Story

Bipolar hip implant system; features cross-linked polyethylene bearing surface with locking mechanism to prevent insert loosening, head disassociation, and osteolysis. Includes UHMWPE support ring permanently fixed in shell and UHMWPE locking ring for head retention. Compatible with 22, 28, 32, and 36mm femoral heads (excluding those with skirts). Used by surgeons in orthopedic procedures to replace femoral head while preserving acetabulum. Device provides stable articulation for patients with femoral neck pathology.

Clinical Evidence

No clinical data provided. Bench testing only; non-pyrogenic status confirmed via LAL testing.

Technological Characteristics

Bipolar hip prosthesis; materials include UHMWPE (support and locking rings). Design features cross-linked polyethylene bearing surface. Sterilization methods identical to predicate. No technological differences from predicate device.

Indications for Use

Indicated for patients with pathological femoral neck fractures, non-union of femoral neck fractures, aseptic necrosis of the femoral head/neck, or primary pathology of the femoral head/femur with a non-deformed acetabulum.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• GLADIATOR® Bipolar System (K062693)

Reference Devices

• EVOLUTION Cementless Femur (K140735)

Submission Summary (Full Text)

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February 23, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Onkos Surgical, Inc. Jan Triani Regulatory Affairs 77 East Halsev Road Parsippany, New Jersey 07054

Re: K180130

Trade/Device Name: ELEOSTM Bipolar Acetabular System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: January 16, 2018 Received: January 17, 2018

Dear Ms. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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) K180130

Device Name ELEOSTM Bipolar Acetabular System

Indications for Use (Describe)

The ELEOSTM Bipolar Acetabular System is indicated for the following conditions:

1) pathological fractures of the femoral neck

2) non-union of femoral neck fractures

3) aseptic necrosis of the femoral head and neck

4) primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

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)

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Onkos Surgical®, Inc. ELEOS™ Bipolar Acetabular System

# 5. 510(k) Summary

## I. SUBMITTER

Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054

Phone: [phone]

Contact Person: Jan Triani Email: [e-mail]

Date Prepared: February 15, 2018

# II. DEVICE

| Name of Device: | ELEOS™ Bipolar Acetabular System |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Bipolar Hip System |
| Classification Name: | 21 CFR 888.3390, Prosthesis, Hip, Hemi-, femoral<br>Metal/Polymer, Cemented or uncemented – Class I |
| Regulatory Class: | II |
| Product Code: | KWY |

## III. PREDICATE DEVICE

GLADIATOR® Bipolar System, K062693

Reference Device: EVOLUTION Cementless Femur, K140735

# IV. DEVICE DESCRIPTION

ELEOS™ Bipolar Acetabular System is a bipolar hip implant design that features a cross-linked polyethylene bearing surface with a lock detail enhanced for strength. Historical concerns with traditional bipolar designs have included loosening of the insert, disassociation of the head from the shell, and osteolysis resulting from polyethylene wear. This system is designed to address these concerns to give surgeons greater confidence when using a bipolar implant.

There is an UHMWPE support ring inside the shell that is permanently fixed. There is also an UHMWPE locking ring that assembles above the support ring and locks into place once the head is inserted into the shell. Bipolar heads are available in a variety of diameters with corresponding

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## Onkos Surgical®, Inc. ELEOS™ Bipolar Acetabular System

internal diameters for 22, 28, 32 and 36mm femoral heads with skirts are not compatible with the bipolar shells.

# V. INDICATIONS FOR USE

The ELEOS™ Bipolar Acetabular System is indicated for the following conditions:

1)pathological fractures of the femoral neck

- 2) non-union of femoral neck fractures
- 3) aseptic necrosis of the femoral head and neck

4) primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERSTICS WITH THE PREDICATE DEVICE

The predicate device 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 (K062693) is provided because there are no technological differences between the subject and predicate devices. Non-pyrogenic status was determined using the LAL test with an identified acceptable testing limit. Testing to monitor pyrogens will be performed using periodic testing.

# VIII. CONCLUSIONS

Since the subject device is the same as the predicate device, the ELEOS™ Bipolar Acetabular System has the same safety and effectiveness profile as the predicate device.