(45 days)
Not Found
No
The summary describes a size extension of a previously cleared hip stem and focuses on material properties and mechanical testing, with no mention of AI or ML.
Yes
The device is a femoral stem used in total hip replacement or bipolar hip replacement, which are procedures designed to treat various joint diseases and correct functional deformities. These are therapeutic interventions aimed at restoring function and alleviating pain in patients.
No
The document describes a device used for total hip replacement or bipolar hip replacement surgery, indicating it's a therapeutic or prosthetic device, not one used for diagnosis.
No
The device description explicitly states it is a "femoral stem" forged from Ti-6A1-4V alloy and is a physical implant for hip replacement surgery. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device used in surgical procedures for total or bipolar hip replacement. This is a surgical implant, not a diagnostic test performed on biological samples.
- Device Description: The description details a femoral stem made of Ti-6A1-4V alloy, designed for cementless use in hip replacement surgery. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a surgical implant used to treat conditions affecting the hip joint.
N/A
Intended Use / 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; 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 to the cleared "UNITED" UTF Stem-Reduced (K123550). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem-Reduced except for its large size. As the same as the cleared UTF Stem-reduced (K123550), the subjected device forged from Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device (#12~#14) is not the worst case within all sizes of UTF Stem-reduced (#1~#14). This device modification would not affect the safety and effectiveness.
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
UTF Stem-reduced, Additional Sizes
510(k) Summary of Safety and Effectiveness
| Submitted by: | 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 |
| Date of Summary: | July 15, 2013 |
| Contact Person | Fang-Yuan Ho |
| AUG 3 0 2013 | |
| Regulation and Document Management | |
| Proprietary Name: | UTF Stem-reduced, Additional Sizes |
| Common Name: | Hip stem |
| Device Classification | Hip joint metal/polymer/metal semi-constrained porous-coated |
| Name and Reference: | uncemented prosthesis under 21CFR 888.3358 |
| This falls under the Orthopedics panel. | |
| Device Class | Class II |
| Panel Code | Orthopaedics Device |
| Device Product Code: | LPH, KWY, LZO |
| Predicate Device: | "UNITED" UTF Stem, Reduced (K123550) |
Device Description:
This subject device is a size extension to the cleared "UNITED" UTF Stem-Reduced (K123550). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem-Reduced except for its large size. As the same as the cleared UTF Stem-reduced (K123550), the subjected device forged from Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580).
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1
O UTF Stem-reduced, Additional Sizes
Indications:
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; 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.
Basis for Substantial Equivalence:
The subject device is a size extension to the cleared "UNITED" UTF Stem-Reduced (K123550). The indications, materials, design, manufacturing process and sterilization method of the subject device are identical to the cleared "UNITED" UTF Stem-Reduced (K123550).
Performance Data:
The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device (#12~#14) is not the worst case within all sizes of UTF Stem-reduced (#1~#14). This device modification would not affect the safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES-USA" and "DEPARTMENT OF" are arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenne Document Control Center - W(%6-(1609 Silver Spring, MD 20993-0002
August 30, 2013
United Orthopedic Corporation % Ms. Fang-Yuan Ho No 57, Park Ave 2, Science Park . Hsinchu 300 Taiwan
Re: K132207 Trade/Device Name: UTF Stem-reduced, Additional Sizes 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: LPI-, KWY, LZO Dated: July 31, 2013 Received: August 1, 2013
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 10 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, I-DA 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
3
Page 2 - Ms. Fang-Yuan Ho
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
K132207 510 (k) Number (if known):
Device Name: UTF Stem-reduced, Additional Sizes_
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; 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page l of l
Elizabeth L. Frank -S
Division of Orthopedic Devices
UOC-FDA-029
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