(205 days)
No
The document describes a size extension of a previously cleared hip stem and focuses on mechanical testing and substantial equivalence to predicate devices. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a total hip replacement stem, which is used to treat various degenerative joint diseases and functional deformities, directly providing therapeutic benefit to the patient.
No
The device description indicates it is a "modular, wedge-shaped stem" used in "hip arthroplasty," and the intended use lists conditions for total hip replacement, which are all treatments, not diagnoses.
No
The device description and performance studies clearly indicate this is a physical implant (a hip stem) and not a software-only device. The tests performed are for mechanical properties and biocompatibility of a physical object.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip replacement. This is a therapeutic device used in vivo (within the body) to treat a medical condition.
- Device Description: The description details a modular, wedge-shaped stem for hip arthroplasty, which is consistent with a surgical implant.
- Performance Studies: The performance studies listed (Stem Fatigue Test, Neck Fatigue Test, Range of Motion, Bacterial endotoxin testing) are all relevant to the mechanical and biological safety of a surgical implant, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is indicated for use in total hip replacement undergoing primary and revision surgery for the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed.
This device is designed for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, KWY, LZO
Device Description
This subject device is a size extension of the cleared "UNITED" UTF Stem - reduced (K123550, K132207). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem - reduced (K123550, K132207) except for size distribution. "UNITED" UTF Stem - reduced is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is indicated for use in primary or revision hip arthroplasty. UTF Stem - reduced is available with standard offset and high offset options to restore hip biomechanics.
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)
Non-clinical Performance:
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:
- a. Stem Fatigue Test
- b. Neck Fatigue Test
- c. Range of Motion
- d. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP
Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
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.
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
§ 888.3358 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.
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2017
United Orthopedic Corporation Gimpel Chien Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu. 300 TW
Re: K163193 Trade/Device Name: UTF Stem, reduced, #0, #00 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, KWY, LZO Dated: April 14, 2017 Received: April 17, 2017
Dear Gimpel Chien:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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" (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.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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)
Device Name
UTF Stem, reduced, #0, #00
Indications for Use (Describe)
This device is indicated for use in total hip replacement undergoing primary and revision surgery for the following conditions:
-
Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
-
Inflammatory degenerative joint disease such as rheumatoid arthritis.
-
Correction of functional deformity.
-
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
Revision procedures where other treatments or devices have failed.
This device is designed for 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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K163193 PAGE 1 OF 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. 2217 |
| Fax Number | +886-3-577156 |
| Name of Contact Person | Gimpel Chien |
| Regulation and Document Management | |
| Date prepared | November 10, 2016 |
| Name of Device | |
| Trade Name | UTF Stem, reduced, #0, #00 |
| Common Name | Hip Stem |
| Regulation Name and | |
| Number | The device classification for UTF Stem, reduced, #0, #00 is |
| "Hip joint metal/polymer/metal semi-constrained | |
| porous-coated uncemented prosthesis." and is contained in the | |
| Code of Federal Regulation, under 21CFR 888.3358. This | |
| falls under the Orthopedic Panel. | |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | LPH, KWY, LZO |
| Predicate Device | 1. “UNITED” UTF Stem, Reduced (K123550) |
4
Device Description:
This subject device is a size extension of the cleared "UNITED" UTF Stem - reduced (K123550, K132207). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem - reduced (K123550, K132207) except for size distribution. "UNITED" UTF Stem - reduced is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is indicated for use in primary or revision hip arthroplasty. UTF Stem - reduced is available with standard offset and high offset options to restore hip biomechanics.
Indications for Use:
This device is indicated for use in total hip replacement or bipolar hip replacement undergoing primary and revision surgery for the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusion acetabuli, and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
- Correction of functional deformity. 3.
-
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. 5.
This device is designed for cementless use.
Comparison to Predicate Device:
The subject device is a size extension to the cleared "UNITED" UTF Stem-Reduced (K123550, K132207). The indications, materials, design, manufacturing process of the subject device are identical to the cleared "UNITED" UTF Stem-Reduced (K123550, K132207). Besides, the indications, materials, manufacturing process of the subject device are identical to the cleared "UNITED" UTF Stem (K110245), except for the reduced distal width and the enlarged thread diameter of the impact hole. However, the design modifications do not change the intended use or fundamental scientific technology. The
5
(9) UTF Stem, reduced, #0, #00
subject device is smallest size option of UTF reduced stem and the mechanical properties including neck fatigue and stem fatigue have been conducted to evaluate the safe and performance and test results demonstrated that the subject device is as safe and effective as the predicates.
Performance Data:
● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:
- a. Stem Fatigue Test
- b. Neck Fatigue Test
- c. Range of Motion
- d. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP
Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.