(193 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a hip stem implant, with no mention of AI or ML.
Yes.
The device is an implantable prosthetic used to replace diseased or damaged hip joints in conditions such as osteoarthritis and rheumatoid arthritis, which are therapeutic interventions.
No
The device description clearly states it is a "single use implant" and a "hip stem" for "hip arthroplasty". Its intended use is to treat various degenerative joint diseases and fractures, not to diagnose them.
No
The device description clearly states it is a "single use implant" and describes physical components made of Co-Cr-Mo alloy, PMMA, and UHMWPE, which are hardware materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a single use implant intended for cemented use only in hip arthroplasty. It is a physical component (a femoral stem) that is surgically implanted into the body.
- Intended Use: The intended uses listed are all related to treating conditions of the hip joint through surgical implantation, not through testing biological samples.
Therefore, this device falls under the category of a medical device (specifically, an implantable orthopedic device), but not an In Vitro Diagnostic.
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.
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
This device is a single use implant and intended for cemented use only.
Product codes
LZO, JDI, LWJ, KWY
Device Description
UCP (United Cement Polished) stem is a triple tapered, polished, collarless stem. It is available for three series: Standards offset, High offset and Long stem to accommodate various surgical requirements. UCP Stem is intended to be fixed only with the use of PMMA bone cement and should be used with centralizer and cement restrictor. UCP stem, centralizer and cement restrictor are made of Co-Cr-Mo alloy (ASTM F799-11), PMMA and UHMWPE (ASTM F648-14/ISO5834), respectively. UCP Stem is intended to use for primary or revision hip arthroplasty. For total hip arthroplasty, UCP Stem can be used with UNITED acetabular liner, cup and femoral head. For bipolar hip replacement, UCP Stem can be used with UNITED bipolar prosthesis.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
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".
The following mechanical tests of the UCP Stem were performed:
a. Stem Fatigue Test
b. Neck Fatigue Test
c. Range of Motion
d. Mechanical Testing for Ceramic Femoral Head while Collocating with UCP Stem
Clinical Performance Data/Information
None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2016
United Orthopedic Corporation Ms. Karen Ho Regulatory Affairs Manager Number 57, Park Avenue 2, Science Park Hsinchu 300 TAIWAN
Re: K152530 Trade/Device Name: UCP Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI, LWJ, KWY Dated: January 29, 2016 Received: February 1, 2016
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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 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
Indications for Use
510(k) Number (if known) K152530
Device Name UCP Stem
Indications for Use (Describe)
-
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.
-
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
-
Revision procedures where other treatments or devices have failed.
-
Patients suffering from disability due to previous fusion.
-
Patients with acute femoral neck fractures.
This device is a single use implant and intended for cemented use only.
| 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)
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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 | March 3, 2016 |
| Name of Device | |
| Trade Name | UCP Stem |
| Common Name | Hip Stem |
| Regulation Name and | |
| Number | The device classification for UCP Stem is: |
| 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; | |
| 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis; | |
| 21 CFR 888.3360: Hip joint femoral (hemi hip) metallic cemented or uncemented prosthesis; | |
| 21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. This falls under the Orthopedic Panel. | |
| Device Class | Class II |
| Classification | Orthopedics |
| Product Code | LZO, JDI, LWJ, KWY |
| Predicate Device | 1. “DePuy” DePuy C-Stem AMT (K082239) |
- “Zimmer” CPT® 12/14 Hip Prostheses (K030265) |
Device Description:
UCP (United Cement Polished) stem is a triple tapered, polished, collarless stem. It is available for three series: Standards offset, High offset and Long stem to accommodate
4
19 UCP Stem
various surgical requirements. UCP Stem is intended to be fixed only with the use of PMMA bone cement and should be used with centralizer and cement restrictor. UCP stem, centralizer and cement restrictor are made of Co-Cr-Mo alloy (ASTM F799-11), PMMA and UHMWPE (ASTM F648-14/ISO5834), respectively. UCP Stem is intended to use for primary or revision hip arthroplasty. For total hip arthroplasty, UCP Stem can be used with UNITED acetabular liner, cup and femoral head. For bipolar hip replacement, UCP Stem can be used with UNITED bipolar prosthesis.
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.
-
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
-
- Revision procedures where other treatments or devices have failed.
- Patients suffering from disability due to previous fusion. న్.
-
- Patients with acute femoral neck fractures.
This device is a single use implant and intended for cemented use only.
Comparison to Predicate Device:
From view of the material, design rationale, intended use and sterilization method, UCP Stem is substantial equivalent to the predicate devices. The difference between the subject and the predicate devices is size distribution. However, the stem length of UCP Stem is within the size range of the predicate devices. The difference of size distribution does not affect the intended use of the device or alter the fundamental scientific technology of the device. As a result, UCP Stem is substantially equivalent to the predicate devices.
Performance Data:
- Non-clinical Performance
5
UCP Stem
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".
The following mechanical tests of the UCP Stem were performed:
- a. Stem Fatigue Test
- b. Neck Fatigue Test
- c. Range of Motion
- d. Mechanical Testing for Ceramic Femoral Head while Collocating with UCP Stem
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.