(135 days)
No
The document describes a hip implant system and its indications for use. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The submission focuses on expanding and unifying the indications for existing, cleared devices.
Yes
The device is a hip implant indicated for pain reduction, relief, and improved hip function in patients with various degenerative joint diseases and conditions, which are therapeutic goals.
No
This device is an implantable hip arthroplasty system used for the treatment of various hip conditions, not for diagnosing them. It is a therapeutic device.
No
The device description explicitly states it is a single-use implant and refers to components, materials, and processing methods, indicating a physical medical device, not software.
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, tissue) to provide information about a person's health.
- Device Description: The provided text describes a hip implant system used in hip arthroplasty (joint replacement surgery). This is a surgical device implanted directly into the body.
- Intended Use: The intended use clearly states the device is for reducing pain and improving hip function in patients with various hip conditions. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device described is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- Correction of function deformity; 3.
- · 4. Revision procedures where other treatments or devices have failed;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5. 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
LPH, JDI, MEH
Device Description
There are two purposes in current submission, the fist one is to expand the Indications for Use of two cleared products: U2 Hip System (K111546) and Femoral Heads, +2.5 & +7.5 mm Offset (K122504), which have been expanded to a population with similar demographic, diagnosis and prognosis as the original. The second purpose of this submission is to reword the statement of Indications for Use of six cleared "UNITED" hip products including U1 Hip System (K994078), U2 Hip Stem, Ti porous coated (K003237), U2 Acetabular Cup and Femoral Head (K022520), U2 Acetabular Component (K050262), U2 Hip Stem and Ti Plasma Spray (K062978) and U2 Acetabular Cup, Plasma Spray (K121777). Through this submission, the Indications for Use of above listed devices are unified as one version, and the components, materials, design, processing methods, sterilization methods, biocompatibility, safety and effectiveness of above listed devices are unchanged by this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
Indicated Patient Age Range
skeletally mature patients
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 laboratory testing is not provided as a basis for substantial equivalence.
None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
"UNITED" U1 Hip System (K994078), "UNITED" U2 Hip Stem, Ti porous coated (K003237), "UNITED" U2 Acetabular Cup and Femoral Head (K022520), "UNITED" U2 Acetabular Component (K050262), "UNITED" U2 Hip Stem, Ti Plasma Spray (K062978), "UNITED" U2 Hip System (K111546), "UNITED" U2 Acetabular Cup, Plasma Spray (K121777), "UNITED" Femoral Heads, +2.5 & +7.5 mm Offset (K122504)
Reference Device(s)
"WRIGHT" STEM Hip Replacement System (K021346), "HOWMEDICA" Stryker Modular Hip System (K071082), "BIOMET" Medallion Modular Hip System (K041850), "UNITED" U1 Hip System-Bipolar (K050269), "UNITED" U2 Bipolar Implant (K101670), "Smith & Nephew" Global Bipolar System (K023743), "BIOMET" RingLoc® Bi-Polar Acetabular Component (K051569)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K130149 (pg 1/4)
ഗ്ര U2 Hip System, Expanded Indications for Use
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: | +886-3-577156 | |
| Date of Summary: | January 16, 2013 | |
| Contact Person: | Fang-Yuan Ho | |
| Manager, Regulatory Affairs | ||
| Proprietary Name: | U2 Hip System, Expanded Indications for Use | |
| Common Name: | Total hip prostheses | |
| Device Classification Name and Reference: | Hip joint metal/polymer/metal semi-constrained porous-coated | |
| uncemented prosthesis under 21CFR 888.3358 | ||
| This falls under the Orthopedics panel. | ||
| Device Class | Class II | |
| Panel Code | Orthopaedics Device | |
| Device Product Code: | LPH, JDI, MEH | |
| Predicate Device: | 1. "UNITED" U1 Hip System (K994078) | |
| 2. "UNITED" U2 Hip Stem, Ti porous coated (K003237) | ||
| 3. "UNITED" U2 Acetabular Cup and Femoral Head (K022520) | ||
| 4. "UNITED" U2 Acetabular Component (K050262) | ||
| 5. "UNITED" U2 Hip Stem, Ti Plasma Spray (K062978) | ||
| 6. "UNITED" U2 Hip System (K111546) | ||
| 7. "UNITED" U2 Acetabular Cup, Plasma Spray (K121777) | ||
| 8. "UNITED" Femoral Heads, +2.5 & +7.5 mm Offset (K122504) |
UOC-FDA-026
Page: Summary-1/4
1
ਹ U2 Hip System, Expanded Indications for Use
Device Description:
There are two purposes in current submission, the fist one is to expand the Indications for Use of two cleared products: U2 Hip System (K111546) and Femoral Heads, +2.5 & +7.5 mm Offset (K122504), which have been expanded to a population with similar demographic, diagnosis and prognosis as the original. The second purpose of this submission is to reword the statement of Indications for Use of six cleared "UNITED" hip products including U1 Hip System (K994078), U2 Hip Stem, Ti porous coated (K003237), U2 Acetabular Cup and Femoral Head (K022520), U2 Acetabular Component (K050262), U2 Hip Stem and Ti Plasma Spray (K062978) and U2 Acetabular Cup, Plasma Spray (K121777). Through this submission, the Indications for Use of above listed devices are unified as one version, and the components, materials, design, processing methods, sterilization methods, biocompatibility, safety and effectiveness of above listed devices are unchanged by this submission.
Indications for Use:
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- Correction of function deformity; 3.
- · 4. Revision procedures where other treatments or devices have failed;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5. 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.
UOC-FDA-026
Page: Summary-2/4
2
(ਗੋ U2 Hip System, Expanded Indications for Use
510(k) Summary
Basis for Substantial Equivalence:
The components, design, materials, packaging materials and sterilization method of U2 Hip System- Expanded Indications for Use are identical to cleared predicate devices:
-
"UNITED" U1 Hip System (K994078)
-
"UNITED" U2 Hip Stem, Ti porous coated (K003237)
-
"UNITED" U2 Acetabular Cup and Femoral Head (K022520)
-
"UNITED" U2 Acetabular Component (K050262)
-
"UNITED" U2 Hip Stem, Ti Plasma Spray (K062978)
-
"UNITED" U2 Hip System (K111546)
-
"UNITED" U2 Acetabular Cup, Plasma Spray (K121777)
-
"UNITED" Femoral Heads, +2.5 & +7.5 mm Offset (K122504)
The only difference between the proposed and predicate devices is the integration of Indications for Use. The submitted indications are substantially equivalent to the predicate products and do not affect the functional effectiveness and safety.
Besides, the indications are substantially equivalent to legally marketed "WRIGHT" STEM Hip Replacement System (K021346), "HOWMEDICA" Stryker Modular Hip System (K071082) and "BIOMET" Medallion Modular Hip System (K041850) for total hip replacement. In the other hand, for bipolar hip replacement, the indications of current submission are identical to "UNITED" U1 Hip System-Bipolar (K050269) and "UNITED" U2 Bipolar Implant (K101670), and are also equivalent to "Smith & Nephew" Global Bipolar System (K023743) and "BIOMET" RingLoc® Bi-Polar Acetabular Component (K051569).
Summary of Technologies
The technological characteristics (design, materials, packaging materials and sterilization method) of the U2 Hip System- Expanded Indications for Use are identical
Page: Summary-3/4
3
ക U2 Hip System, Expanded Indications for Use
510(k) Summary
to the predicate products.
Non-Clinical Testing
Non-clinical laboratory testing is not provided as a basis for substantial equivalence.
Clinical Testing
None provided as a basis for substantial equivalence.
UOC-FDA-026
Page: Summary-4/4
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6. 2013
United Orthopedic Corporation % Fang-Yuan Ho Regulatory Affairs. Manager No. 57. Park Avenue 2, Science Park Hsinchu 300 Taiwan
Re: K130149
Trade/Device Name: U2 Hip System 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, JDI. MEH Dated: March 8, 2013
Received: March 13, 2013
Dear Fang-Yuan 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. Iisting 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
5
Page 2 – Fang-Yuan Ho
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 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.
ff 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. 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/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 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 Keith
| For | Mark N. Melkerson |
|---|---|
| Director | |
| Division.of.Orthopedic.Devices. | |
| Office of Device Evaluation | |
| Center for Devices and | |
| Radiological Health |
Enclosure
6
Indication for Use
K130149 (pg 1/1) 510 (k) Number (if known):
Device Name: U2 Hip System, Expanded Indications for Use
Indications for Use:
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- 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.
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 Frank -S
Division of Orthopedic Devices
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