(87 days)
No
The summary describes a physical implant (femoral stem) and its materials and mechanical properties. There is no mention of software, algorithms, AI, or ML.
Yes.
The device is a femoral stem for hip arthroplasty, intended to treat degenerative joint diseases and correct deformities, which are therapeutic medical conditions.
No
This device is a surgical implant (femoral stem) used for hip arthroplasty, which is a treatment rather than a diagnostic procedure. Its purpose is to correct functional deformities and treat joint diseases.
No
The device description clearly states it is a "single use implant" and a "modular stem" made from a Ti-6Al-4V alloy, which are physical hardware components. The summary also details mechanical performance testing of the stem.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a femoral stem, which is an implantable medical device used in hip replacement surgery. It is surgically inserted into the patient's body.
- Intended Use: The intended uses listed are all related to treating conditions affecting the hip joint through surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, laboratory testing, or providing diagnostic information based on in vitro analysis.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis.
- 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 is unmanageable using other techniques.
This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The U2 Ti Porous Coated Matrix Stem is single use component intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Ti Porous Coated Matrix Stem, made from a Ti-6Al-4V alloy conforming to ASTM F136-13/ISO 5832-3:1996, is a modular stem with 12/14 neck taper and 130° neck angle.
The proximal part of each femoral stem is coated with porous coating in thickness 600±100 um using -45+60 mesh of CP Ti powder (ASTM F1580-12). The bulleted geometry stem tip of U2 Ti Porous Coated Matrix Stem helps reduce distal point loading while creating a smooth transition zone for load transfer. This stem system is available in thirteen sizes. U2 Ti Porous Coated Matrix Stem can be used with U1, U2 Acetabular components (K994078, K050262, K12177, K111546), U-Motion II Acetabular System components (K122185, K132455) and UNITED Femoral Head (K994078, K022520, K122504, K103497, K111546, K112463, K122185) for total hip replacement. For hip hemi-arthroplasty, U2 Ti Porous Coated Matrix Stem can be used in conjunction with Bipolar products (K101670).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
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, and the test results comply with the recommendations according to the FDA guidance "Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Protheses" and "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement".
The following mechanical tests of the U2 Hip Ti Porous Coated Stem were performed:
- a. Stem Fatigue Test with Torsion
- b. Neck Fatigue Test with Torsion
- Mechanical Properties of Titanium Porous Coating Surface
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.
K994078, K050262, K12177, K111546, K122185, K132455, K022520, K122504, K103497, K112463, 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
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
August 13, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
United Orthopedic Corporation Ms. Karen Ho Regulatory Affairs Manager 57, Park Avenue 2, Science Park Hsinchu, 300 Taiwan, Republic of China
Re: K151316
Trade/Device Name: U2 Hip Stem, Ti Porous Coated, Matrix 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 Dated: May 15, 2015 Received: May 18, 2015
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
1
Page 2 - Ms. Karen Ho
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 (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 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
K151316 (page 1 / 1) 510 (k) Number (if known):____
Device Name: U2 Hip Stem, Ti Porous Coated, Matrix
Indications for Use:
-
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 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 is unmanageable using other techniques.
This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.
Prescription Use 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 | May 15, 2015 |
| Name of Device | |
| Trade Name | U2 Hip Stem, Ti Porous Coated, Matrix |
| Common Name | Cementless Hip Stem |
| Classification Name and | |
| Regulation | The device classification for U2 Hip Stem, Ti Porous |
| Coated, Matrix 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 |
| Predicate Device | The predicate device is the “UNITED” U2 Hip Stem, Ti |
| Porous Coated (K003237) |
Device Description:
The U2 Ti Porous Coated Matrix Stem is single use component intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Ti Porous Coated Matrix Stem, made from a Ti-6Al-4V alloy conforming to ASTM F136-13/ISO 5832-3:1996, is a modular stem with 12/14 neck taper and 130° neck angle.
4
0 U2 Hip Stem, Ti Porous Coated, Matrix
The proximal part of each femoral stem is coated with porous coating in thickness 600±100 um using -45+60 mesh of CP Ti powder (ASTM F1580-12). The bulleted geometry stem tip of U2 Ti Porous Coated Matrix Stem helps reduce distal point loading while creating a smooth transition zone for load transfer. This stem system is available in thirteen sizes. U2 Ti Porous Coated Matrix Stem can be used with U1, U2 Acetabular components (K994078, K050262, K12177, K111546), U-Motion II Acetabular System components (K122185, K132455) and UNITED Femoral Head (K994078, K022520, K122504, K103497, K111546, K112463, K122185) for total hip replacement. For hip hemi-arthroplasty, U2 Ti Porous Coated Matrix Stem can be used in conjunction with Bipolar products (K101670).
Intended Use:
- 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.
-
- Correction of function deformity.
- Revision procedures where other treatments or devices have failed. 4.
- న్. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.
Comparison to Predicate Device:
U2 Hip Stem. Ti Porous Coated. Matrix is modification and an additional size extension U2 Hip Ti Porous Coated Stem which was previously cleared by FDA (K003237). The differences from the existing products include design change for porous-coated area, modifying stem tip from cylindrical to bulleted geometry and modifying impact hole.
5
0 U2 Hip Stem, Ti Porous Coated, Matrix
Performance Data:
● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results comply with the recommendations according to the FDA guidance "Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Protheses" and "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement".
The following mechanical tests of the U2 Hip Ti Porous Coated Stem were performed:
- a. Stem Fatigue Test with Torsion
- b. Neck Fatigue Test with Torsion
- Mechanical Properties of Titanium Porous Coating Surface ﻥ
- Clinical Performance Data/Information
None provided as a basis for substantial equivalence.