(224 days)
No
The device description focuses on the materials and mechanical design of a hip implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for hip replacement and treats various degenerative joint diseases and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure medical conditions.
No
This device is an implantable hip prosthesis, not a tool for diagnosing conditions. Its purpose is to treat existing hip conditions through replacement.
No
The device description clearly details a physical implant made of metal and polyethylene, intended for surgical implantation. It describes material composition, dimensions, and assembly, indicating a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to replace a hip joint. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details the materials and construction of a physical implant designed to articulate within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
-
- Correction of function deformity.
-
- Revision procedures where other treatments or devices have failed.
- Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
KWY
Device Description
U2 Bipolar Implant
U2 Bipolar Implant is intraoperatively assembled to any appropriately size UNITED femoral stem with compatible head size. This device is offered in 38-56 mm outer diameters and with 22mm, 26mm and 28mm inner diameter. It is comprised of an outer shell (ASTM F75-12/ ISO 5832-4:2014 casting Co-Cr-Mo allov, raw materials ASTM F1537-11/ISO 5832-12:2007) into a permanently assembled bearing insert (ASTM F648-14/ISO 5834-1:2005 and ISO 5834-2:2011). The minimum thickness of the polyethylene at the load bearing area is 5 mm. The assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surface of the bipolar hip prosthesis is highly polished for articulation with the patient's acetabulum.
Femoral Head, 22mm
Femoral head for size 22mm is designed for use with U2 Bipolar Implant. It is made of Co-Cr-Mo alloy (ASTM F1537-11). The material and process method of 22 mm femoral head are identical to the previous cleared "United" femoral head (K994078).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur, femoral neck
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)
- Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:- a. Locking Mechanism of U2 Bipolar Implant
- b. Range of Motion of U2 Bipolar Implant
- c. Disassembly Force for Femoral Head and Stem
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.
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.
K101670, K050269, K994078, K800207, K964769, K013211, K060707
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
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2016
United Orthopedic Corporation Ms. Karen Ho Regulatory Affairs Manager Number 57, Park Avenue 2, Science Park Hsinchu 300 TAIWAN
Re: K152439 Trade/Device Name: U2 Bipolar Implant and 22mm Femoral Head 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: March 8, 2016 Received: March 11, 2016
Dear Ms. Ho:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for Use
K152439 510 (k) Number (if known):
Device Name: U2 Bipolar Implant and 22mm Femoral Head
Indications for Use:
This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
-
- Correction of function deformity.
-
- Revision procedures where other treatments or devices have failed.
- న. Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Prescription Use _ x x _ Over-The-Counter Use ___ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary of Safety and Effectiveness
Submitter Information
| Name | United Orthopedic Corporation |
|---|---|
| Address | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan |
| Phone Number | +886-3-5773351 ext. 2212 |
| Fax Number | +886-3-577156 |
| Name of Contact Person | Karen Ho |
| Regulation and Document Management | |
| Date prepared | August 21, 2015 |
| Name of Device | |
| Trade Name | U2 Bipolar Implant and 22 mm Femoral Head |
| Common Name | Bipolar Implant and Femoral Head |
| Classification Name and | The device classification for U2 Bipolar Implant and 22 mm |
| Regulation | Femoral Head is "Hip Joint femoral (Hemi-Hip) |
| Metal/Polymer Cemented or Uncemented Prosthesis " and is | |
| contained in the Code of Federal Regulation, under 21CFR | |
| 888.3390. This falls under the Orthopedic Panel. | |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | KWY |
| Predicate Device | 1. "United" U2 Bipolar Implant (K101670) |
| 2. "United" U1 Hip System-Bipolar (K050269) | |
| 3. "United" U1 Hip System--Femoral Head (K994078) | |
| 4. "Stryker" UHR Universal Head Bipolar System (K800207) | |
| 5. "Zimmer" VerSys Hip System--Femoral Head (K964769) | |
| 6. "Exactech" AcuMatch L-Series Bipolar Endoprosthesis (K013211) | |
| 7. "Aesculap" Aesculap BiPolar Acetabular Cup (K060707) |
4
Device Description:
U2 Bipolar Implant
U2 Bipolar Implant is intraoperatively assembled to any appropriately size UNITED femoral stem with compatible head size. This device is offered in 38-56 mm outer diameters and with 22mm, 26mm and 28mm inner diameter. It is comprised of an outer shell (ASTM F75-12/ ISO 5832-4:2014 casting Co-Cr-Mo allov, raw materials ASTM F1537-11/ISO 5832-12:2007) into a permanently assembled bearing insert (ASTM F648-14/ISO 5834-1:2005 and ISO 5834-2:2011). The minimum thickness of the polyethylene at the load bearing area is 5 mm. The assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surface of the bipolar hip prosthesis is highly polished for articulation with the patient's acetabulum.
Femoral Head, 22mm
Femoral head for size 22mm is designed for use with U2 Bipolar Implant. It is made of Co-Cr-Mo alloy (ASTM F1537-11). The material and process method of 22 mm femoral head are identical to the previous cleared "United" femoral head (K994078).
Intended Use:
This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
-
- Correction of function deformity.
- Revision procedures where other treatments or devices have failed. 4.
5
(G) U2 Bipolar Implant and 22mm Femoral Head
- ડ. Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Comparison to Predicate Device:
The subject device--U2 Bipolar Implant is identical to the cleared "United" U2 Bipolar Implant (K101670) except size distribution and the design of stopper ring. However, the size distribution is substantially equivalent to "Exactech" AcuMatch L-Series Bipolar Endoprosthesis (K013211), and the performance evaluation for stopper ring of subject device was also conducted. The differences between subject and predicate devices would not pose issues about safety and effectiveness.
Performance Data:
-
Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device: -
a. Locking Mechanism of U2 Bipolar Implant
-
b. Range of Motion of U2 Bipolar Implant
-
c. Disassembly Force for Femoral Head and Stem
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.