(90 days)
Not Found
No
The document describes a mechanical implant (femoral stem) and its material properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total hip replacement component, which is used to treat various painful and debilitating joint conditions, thus restoring function and alleviating symptoms.
No
This device is described as a "UTS Stem," which is a component used in total hip replacement surgery. Its intended use is to replace damaged hip joints due to various degenerative conditions, fractures, or failed previous treatments. It is a prosthetic implant, not a tool for diagnosis.
No
The device description explicitly states it is a "modular, wedge-shaped stem" made from "forging Ti-6Al-4V alloy" and coated with "CP Ti powder," which are physical components, not software. The performance studies also focus on physical properties like fatigue and surface treatment.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in the body for surgical replacement of a hip joint. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details a physical implantable device (a femoral stem) made of metal, designed to be surgically inserted into the hip. This is not consistent with the nature of an IVD.
- Performance Studies: The performance studies focus on mechanical properties and biocompatibility of the implant (fatigue tests, range of motion, etc.), not on the analytical or clinical performance of a diagnostic test.
- Anatomical Site: The anatomical site is the hip joint, which is where the device is implanted, not where a specimen for an IVD would be collected.
This device is a surgical implant used for total hip replacement.
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, LZO, KWY
Device Description
UTS Stem is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is made from forging Ti-6Al-4V alloy (ASTM F136-13) and the proximal part of each femoral stem is coated with CP Ti powder (ASTM F1580-12) provides biological fixation. UTS Stem is available with standard offset and high offset to restore hip biomechanics. The standard offset is available in sizes #00~#14; the high offset is available in sizes #1~#14.
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. Evaluation of disassembly force and fretting corrosion between femoral head and stem
- e. Evaluation of Modified Surface Treatment
- f. 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.
K110245, K123550, K132207, K163193, K073570
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
United Orthopedic Corporation Gimpel Chien Regulatory Affairs Manager No. 57, Park Avenue 2, Science Park Hsinchu, 300 Taiwan
October 24, 2017
Re: K172251
Trade/Device Name: UTS Stem 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, LZO, KWY Dated: July 21, 2017 Received: July 26, 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, 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 (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.
1
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 (DICE) 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172251
Device Name
UTS Stem
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)
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 PRAStaff(@fda.hhs.gov
"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."
3
ு UTS Stem
510(k) Summary
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 | +886-3-5777156 |
| Name of Contact Person | Gimpel Chien |
| Regulation and Document Management | |
| Date prepared | July 21, 2017 |
| Name of Device | |
| Trade Name | UTS Stem |
| Common Name | Hip Stem |
| Regulation Name and | |
| Number | The device classification for UTS Stem 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 (K110245) |
- "UNITED" UTF Stem, Reduced (K123550)
- "UNITED" UTF Stem-reduced, Additional Sizes
(K132207) - "UNITED" UTF Stem, reduced, #0, #00 (K163193)
- Depuy Tri-lock Bone Preservation Stem (K073570) |
4
UTS Stem
Device Description:
UTS Stem is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is made from forging Ti-6Al-4V alloy (ASTM F136-13) and the proximal part of each femoral stem is coated with CP Ti powder (ASTM F1580-12) provides biological fixation. UTS Stem is available with standard offset and high offset to restore hip biomechanics. The standard offset is available in sizes #00~#14; the high offset is available in sizes #1~#14.
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, 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 features of the subject device including indication for use, material, design rationale, size distribution and sterilization method are discussed in detail as follow to compare with the predicate devices:
1) Indication for use
UNITED UTS Stem is intended to use in total hip replacement or bipolar hip replacement, that is the same as the predicate UNITED UTF Stem-reduced (K123550, K132207,
5
UTS Stem
510(k) Summary
K163193) and UNITED UTF Stem (K110245)
2) Material
The subject UTS Stems are made of Ti-6A1-4V alloy (ASTM F136-13) and plasma coated with CP Ti powder(ASTM F1580-12), which are identical to the predicate UNITED UTF Stem-reduced (K123550, K132207, K163193), UNITED UTF Stem (K110245).
3) Design rationale
The Subjects UTS Stems are Tri-tapered wedge design which is identical to the predicate "Depuy" Tri-lock Bone Preservation Stem (K073570).
4) Size
"UNITED" UTS Stem is an extension line of UTF reduced stem (K123550, K132207, K163193), and the mechanical properties including neck fatigue, stem fatigue and range of motion have been conducted to evaluate the safety and performance.
5) Sterilization method
The subject device is sterilized by Co-60 gamma radiation which is identical with the predicate devices (K110245, K123550, K132207, K163193, K073570).
The subject device is a extension line of the cleared "UNITED" UTF reduced stem (K123550, K132207 and K163193) 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:
6
ு UTS Stem
- a. Stem Fatigue Test
- b. Neck Fatigue Test
- c. Range of Motion
- d. Evaluation of disassembly force and fretting corrosion between femoral head and stem
- e. Evaluation of Modified Surface Treatment
- f. 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.