(311 days)
No
The document describes a standard hip prosthesis system and its mechanical testing. There is no mention of AI, ML, image processing, or any data-driven analytical components.
Yes
The device is a total hip system designed to replace impaired joints and address various hip conditions, indicating its use in treating and ameliorating a medical condition.
No
Explanation: This device is a total hip system, a type of implant used for hip arthroplasty (surgical replacement of a hip joint). Its purpose is to treat significantly impaired joints and other conditions, not to diagnose them.
No
The device description explicitly details physical components like femoral stems, femoral heads, acetabular shells, and liners, which are hardware implants. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The KeYi Total Hip System is a prosthetic implant designed to replace a damaged hip joint. It is surgically implanted into the body.
- Intended Use: The intended use is to treat various conditions affecting the hip joint through surgical replacement, not to perform diagnostic tests on samples.
The description clearly indicates a physical implant used for surgical treatment, which falls outside the scope of In Vitro Diagnostics.
N/A
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.
- 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.
Product codes
LPH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
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 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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111472, K980513, K961186, K001991, K983491
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
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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
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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,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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)
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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: +86-10-67853877 Fax Number: +86-10-67853877 ext. 8117 Email: jiangli@keyibangen.com 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