KeYi Total Hip System

K191826 · Beijing Keyi Medical Device Technology Co., Ltd. · LPH · May 14, 2020 · Orthopedic

Device Facts

• Record ID: K191826
• Device Name: KeYi Total Hip System
• Applicant: Beijing Keyi Medical Device Technology Co., Ltd.
• Product Code: LPH · Orthopedic
• Decision Date: May 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KeYi Total Hip System is designed for total hip arthroplasty. The indications for use are: a. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. b. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. c. Proximal femoral fractures. d. Avascular necrosis of the femoral head. e. Non-union of proximal femoral neck fractures. f. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The Ke Yi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.

Device Story

KeYi Total Hip System is a semi-constrained, porous-coated hip prosthesis for primary or revision total hip arthroplasty. System components include forged titanium alloy femoral stems with proximal CP titanium plasma porous coating; cobalt chromium alloy femoral heads; titanium alloy acetabular shells with CP titanium plasma porous coating; and ultrahigh molecular weight polyethylene (UHMWPE) acetabular liners. Optional components include titanium alloy acetabular dome hole plugs and cancellous bone screws. The device is used by orthopedic surgeons in a clinical/surgical setting. Femoral heads attach to stems via 12/14 taper-locking. Acetabular shells support cemented or cementless fixation; femoral stems are for cementless use. The system replaces damaged hip joint structures to restore joint function and mobility, potentially reducing pain and improving patient quality of life.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing including stem and neck fatigue testing (ISO 7206-4/6), disassembly testing (ASTM F1820, ASTM F2009), wear simulation (ISO 14242-1), range of motion simulation, porous coating characterization, material property characterization, biocompatibility (ISO 10993), and pyrogen testing.

Technological Characteristics

Materials: Forged titanium alloy (stems/shells), cobalt chromium alloy (heads), non-crosslinked UHMWPE (liners). Features: Proximal CP titanium plasma porous coating. Fixation: Cementless (stems), cemented/cementless (shells). Mechanical: 12/14 taper-locking. Standards: ISO 7206-4/6 (fatigue), ASTM F1820/F2009 (disassembly), ISO 14242-1 (wear), ISO 10993 (biocompatibility).

Indications for Use

Indicated for total hip arthroplasty in patients with significantly impaired joints due to rheumatoid, osteoarthritis, or post-traumatic arthritis; revision of failed hip procedures; proximal femoral fractures; avascular necrosis; non-union of femoral neck fractures; or conditions including congenital dysplasia, arthrodesis conversion, coxa plana/vara/valga, metabolic/tumorous conditions, osteoporosis, pseudarthrosis, and structural abnormalities.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• HELICON Hip System (K111472)
• Depuy Articul/Eze femoral Heads (K980513)
• Depuy Duraloc Cementless Acetabular cup system (K961186)
• DePuy Titan Porocoat Hip Stem (K001991)
• Depuy Duraloc Acetabular Cup System-Enduron Liner (K983491)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

Beijing Ke Yi Medical Device Technology Co., Ltd. Jenny Jiang Regulatory Affairs Supervisor Building 1, 30 Yongchang South Road Beijing, 100176 China

May 14, 2020

### Re: K191826

Trade/Device Name: KeYi Total Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH Dated: April 8, 2020 Received: April 14, 2020

Dear Jenny Jiang:

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

{1}------------------------------------------------

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,

Vesa Vuniqi, MS 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K191826

Device Name KeYi Total Hip System

Indications for Use (Describe)

The KeYi Total Hip System is designed for total hip arthroplasty. The indications for use are:

a. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

- b. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- c. Proximal femoral fractures.
- d. Avascular necrosis of the femoral head.
- e. Non-union of proximal femoral neck fractures.

f. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The Ke Yi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.

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.

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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

EF

{3}------------------------------------------------

### 510(k) SUMMARY KeYi Total Hip System

510(k) Owner Information Name: Beijing KeYi Medical Device Technology Co., Ltd. Address: Building 1, 30 Yongchang South Road, Beijing Economic Technological Development Area, 100176 Beijing, China Telephone Number: [phone] Fax Number: [phone] ext. 8117 Email: [e-mail] Contact Person: Jenny Jiang Regulatory Affairs Supervisor Date Prepared: July 1st , 2019 Name of Device KeYi Total Hip System Trade Name / Proprietary Name: Hip Joint Prosthesis Common Name: Product Code: LPH Regulatory Classification: Class II - 21 CFR § 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Orthopedic Device Panel Review Panel: K111472 – HELICON Hip System Predicate Devices: Additional Predicate Device: K980513 - Depuy Articul/Eze femoral Heads K961186 - Depuy Duraloc Cementless Acetabular cup svstem K001991 - DePuy Titan Porocoat Hip Stem K983491 - Depuy Duraloc Acetabular Cup System-Enduron Liner

Reason for 510(k) Submission: New Devices

# Device Description

The KeYi Total Hip System is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The system is comprised of femoral stems and mating metal femoral heads; acetabular shells and mating acetabular liners; optional acetabular cancellous bone screws; and optional acetabular dome hole plug.

The KeYi Femoral Stems are forged titanium alloy, feature a proximal CP Titanium plasma porous coating, and are offered in a range of sizes. The KeYi Femoral Heads are polished

Premarket Notification Confidential Information

{4}------------------------------------------------

cobalt chromium alloy and designed to mate with 12/14 taper of the femoral stem through taperlocking arrangement and to articulate with the acetabular liner. The heads are available in different sizes with various offsets.

The KeYi Acetabular Shells are manufactured from titanium alloy and feature a porous CP Titanium plasma porous coating. The shells feature a dome hole, are available with a two or three-hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The KeYi Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard/non-crosslinked UHMWPE).

Optional components include threaded acetabular dome hole plugs and acetabular cancellous bone screws, all manufactured from titanium alloy.

### Intended Use / Indications for Use

The KeYi Total Hip System is designed for total hip arthroplasty. The indications for use are:

- a. Significantly impaired ioints resulting from rheumatoid, osteo, and post-traumatic arthritis,
- Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. ڪ
- Proximal femoral fractures. C.
- d. Avascular necrosis of the femoral head.
- e. Non-union of proximal femoral neck fractures.
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, f. coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The KeYi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.

### Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

The technological characteristics of the KeYi Total Hip System are similar to predicate devices.

### PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

The following mechanical tests of the KeYi Total Hip System were performed to support the determination of substantial equivalence:

- Stem fatigue test for KeYi femoral stems per ISO 7206-4 .
- Neck fatique test for KeYi femoral stems per ISO 7206-6 .
- Disassembly test of KeYi acetabular shells and UHMWPE liners per ASTM F1820 ●
- Taper disassembly test of KeYi femoral head and taper per ASTM F2009 ●
- . Wear Simulation Test of KeYi acetabular liners per ISO 14242-1
- Range of motion simulation for KeYi total hip system 0
- Porous coating characterization tests
- . Material properties characterization of non-crosslinked UHMWPE
- Biocompatibility test for non-crosslinked UHMWPE per ISO 10993
- . Pyrogen test

#### Conclusion

KeYi Total Hip System is substantially equivalent to the predicate devices.

Premarket Notification Confidential Information