(163 days)
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a hip replacement component, used to treat conditions like osteoarthritis and hip fractures, which alleviates symptoms and restores function, thus qualifying it as a therapeutic device.
No
Explanation: This device is a femoral stem used in total hip or bipolar hip replacement surgery. Its purpose is to replace a damaged or diseased part of the hip joint, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical implant (femoral stem) made of Ti-6A1-4V alloy with specific dimensions and coatings, intended for surgical implantation. It is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "total hip replacement or bipolar hip replacement" in patients with various hip conditions. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a "modular, wedge-shaped stem" made of Ti-6A1-4V alloy, designed for cementless use in hip surgery. This is a physical implant.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Being used in a laboratory setting
The device described is a surgical implant used to replace a damaged hip joint, which is a completely different category of medical device than an in vitro diagnostic.
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 modification and an additional size extension to the previously cleared "UNITED" UTF Stem (K110245). The materials, safety and effectiveness of this subject device are identical to "UNITED" UTF Stem (K110245). Compared with the UTF Stem (K110245), the distal width of UTF Stem-reduced is reduced to provide more selection for clinical demand, and the thread diameter of impact hole of UTF Stem-reduced is enlarged to increase the mechanical strength of stem holder which is locked with impact hole.
As the same as UTF Stem (K110245), UTF Stem-reduced, forged from a Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580) in thickness 500±127μm. UTF Stem-reduced is available with standard and high offset options, and each,type is available in sizes #111. The specifications of UTF Stem-reduced in size #16 and #9 are identical with UTF Stem (K110245) in size #7.5, 9, 10, 11, 12, 13, 16.5, respectively, while size #7, 8, 10 and 11 are new items which is between size # 13 and #22 in UTF Stem (K110245). These modifications will not affect its safety and effectiveness.
For total hip replacement, UTF Stem-reduced can be used in conjunction with UNITED Femoral Head (K994078, K022520, K111546 and K122504), Ceramic Femoral Head (K103497, K112463), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262, K12177), U2 Ti Plasma Spray Cup (K050262, K121777) and U2 Ti Porous Coated Cup (K111546). As using with U2 Acetabular Cup Liner (K050262), UTF Stem-reduced can be used with 26 mm and 28 mm metal Femoral Head (K994078, K022520, K122504) and 28 mm Ceramic Femoral Head (K103497). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546, K122504) and 28 i mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463).
For bipolar hip replacement, UTF Stem-reduced also can be used in conjunction with 26 mm, 28 mm, 32mm and 36mm metal Femoral Head (K994078, K022520, K111546, K122504), 28 mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463) and Bipolar implants (K101670). UNITED Femoral Head and Bipolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged 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 stem fatigue test and neck fatigue test for worst-case in UTF stem (K110245) have been completed according to ISO 7206-4 and ISO 7206-6, respectively. No additional non-clinical testing was performed for UTF Stem-reduced because the enlarged thread diameter of impact hole and reduced distal width did not decrease the stem fatigue strength and neck fatigue strength based on the FEM analysis.
The chemical analysis, microstructural characterization and mechanical strength of the modified coating have also evaluated. The results conform to the requirements of FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements".
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.
K994078, K022520, K111546, K122504, K103497, K112463, K050262, K12177, K121777, K101670
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
510(k) Summary
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: | +886-3-5777156 | |||||||||||||||
| Date of Summary: | November 15, 2012 | |||||||||||||||
| Contact Person: | Fang-Yuan Ho | |||||||||||||||
| Manager, Regulatory Affairs | Proprietary Name: | UTF Stem, reduced | Common Name: | Hip Stem | Device Classification | Hip joint metal/polymer/metal semi-constrained porous-coated | Name and Reference: | uncemented prosthesis under 21CFR 888.3358 | Device Class | Class II | Panel Code | Orthopaedics Device | Device Product Code | LPH, KWY, LZO | ||
| Manager, Regulatory Affairs | ||||||||||||||||
| Proprietary Name: | UTF Stem, reduced | |||||||||||||||
| Common Name: | Hip Stem | |||||||||||||||
| Device Classification | Hip joint metal/polymer/metal semi-constrained porous-coated | |||||||||||||||
| Name and Reference: | uncemented prosthesis under 21CFR 888.3358 | |||||||||||||||
| Device Class | Class II | |||||||||||||||
| Panel Code | Orthopaedics Device | |||||||||||||||
| Device Product Code | LPH, KWY, LZO | |||||||||||||||
| Predicate Device: | "UNITED" UTF Stem (K110245) |
Device Description:
This subject device is a modification and an additional size extension to the previously cleared "UNITED" UTF Stem (K110245). The materials, safety and effectiveness of this subject device are identical to "UNITED" UTF Stem (K110245). Compared with the UTF Stem (K110245), the distal width of UTF Stem-reduced is reduced to provide more selection for clinical demand, and the thread diameter of impact hole of UTF Stem-reduced is enlarged to increase the mechanical strength of stem holder which is locked with impact hole.
UOC-FDA-025
Page: Summary - 1/4
। म
1
As the same as UTF Stem (K110245), UTF Stem-reduced, forged from a Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580) in thickness 500±127μm. UTF Stem-reduced is available with standard and high offset options, and each,type is available in sizes #111. The specifications of UTF Stem-reduced in size #16 and #9 are identical with UTF Stem (K110245) in size #7.5, 9, 10, 11, 12, 13, 16.5, respectively, while size #7, 8, 10 and 11 are new items which is between size # 13 and #22 in UTF Stem (K110245). These modifications will not affect its safety and effectiveness.
For total hip replacement, UTF Stem-reduced can be used in conjunction with UNITED Femoral Head (K994078, K022520, K111546 and K122504), Ceramic Femoral Head (K103497, K112463), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262, K12177), U2 Ti Plasma Spray Cup (K050262, K121777) and U2 Ti Porous Coated Cup (K111546). As using with U2 Acetabular Cup Liner (K050262), UTF Stem-reduced can be used with 26 mm and 28 mm metal Femoral Head (K994078, K022520, K122504) and 28 mm Ceramic Femoral Head (K103497). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546, K122504) and 28 i mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463).
For bipolar hip replacement, UTF Stem-reduced also can be used in conjunction with 26 mm, 28 mm, 32mm and 36mm metal Femoral Head (K994078, K022520, K111546, K122504), 28 mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463) and Bipolar implants (K101670). UNITED Femoral Head and Bipolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged Titanium alloy.
UOC-FDA-025
Page: Summary -2/4
2
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 modification and an additional size extension to the previously cleared "UNITED" UTF Stem (K110245). The safety and effectiveness of the subject device are substantially equivalent to the previously cleared "UNITED" UTF Stem (K110245), except for the reduced distal profile and increased the thread diameter of the impact hole. The modifications do not change the intended use or fundamental scientific technology.
Non-Clinical Testing:
The stem fatigue test and neck fatigue test for worst-case in UTF stem (K110245) have been completed according to ISO 7206-4 and ISO 7206-6, respectively. No additional non-clinical testing was performed for UTF Stem-reduced because the enlarged thread diameter of impact hole and reduced distal width did not decrease the stem fatigue strength and neck fatigue strength based on the FEM analysis.
UOC-FDA-025
Page: Summary -3/4
3
510(k) Summary
The chemical analysis, microstructural characterization and mechanical strength of the modified coating have also evaluated. The results conform to the requirements of FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements".
Based upon engineering analysis of the design modification, UTF Stem-reduced is substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally market predicates.
Clinical Testing:
Clinical testing was not required for this submission.
Page: Summary -4/4
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: May 1, 2013
United Orthopedic Corporation % Ms. Fang-Yuan Ho Regulatory Affairs, Manager No. 57, Park Ave 2, Science Park Hsinchu, Taiwan 300
Re: K123550 Trade/Device Name: UTF Stem, reduced 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 3, 2013 Received: April 4, 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Fang-Yuan Ho
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,
Mark Nimelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510 (k) Number (if known):__K123550
Device Name: UTF Stem, reduced
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 __x (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)
Elizabeth词语rank -S
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Division of Orthopedic Devices