(269 days)
No
The summary describes a hip implant device and its mechanical properties, with no mention of AI or ML technology.
Yes
The device is used for the reduction or relief of pain and/or improved hip function in patients with painful, disabling joint disease of the hip, revision of previous unsuccessful procedures, correction of functional deformity, and treatment of nonunion femoral neck and trochanteric fracture. These uses directly involve treating or alleviating medical conditions, which aligns with the definition of a therapeutic device.
No
The device is an orthopedic implant (acetabular component) used for surgical treatment of hip conditions, not for diagnosing them.
No
The device description clearly states it is an "acetabular component" and discusses physical dimensions and mechanical properties, indicating it is a hardware device used in hip replacement surgery.
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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a device intended for surgical implantation to replace or augment the hip joint. It is used to treat conditions affecting the hip itself, not to analyze bodily fluids or tissues.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic information derived from such analysis.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of pervious unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Correction of function deformity.
- Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
The device is intended for cementless use.
Product codes
LZO, MEH, KWY, LWJ
Device Description
This device is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185) and U-Motion II PS+ Cup (K132455). U-Motion II acetabular component includes U-Motion II Cup and U-Motion II XPE Cup Liner. The indications, materials, design, safety and effectiveness of U-Motion II Cup and Cup Liner are identical to the cleared U-Motion II Acetabular System (K122185) and U-Motion II PS* Cup (K132455) except the dimension. The subject U-Motion II Cups are available in size Ø 50 mm and Ø 46 mm O.D. and the subject U-Motion II Cup Liners are available in 32 mm and 36 mm I.D. The 32 mm and 36 mm inserts fit the acetabular shells with 46 mm O.D. and 50 mm O.D., respectively.
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)
The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device is not the worst case within all sizes of U-Motion II Acetabular System. These adding sizes would not affect the safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
United Orthopedic Corporation October 6, 2017 Gimpel Chien Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu 300 Taiwan Re: K170089 Trade/Device Name: U-motion II Acetabular System- Additional Sizes 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, MEH, KWY, LWJ Dated: September 1, 2017 Received: September 05, 2017
Dear Ms. Chien:
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 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);
1
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 (DICE) 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 (DICE) 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Form Approved: OMB No. 0910-0120 | |
| Indications for Use | Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K170089 |
|---|---|
| Device Name | U-Motion II Acetabular System- Additional sizes |
| Indications for Use (Describe) | |
| The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: | |
| 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. | |
| 2. Revision of pervious unsuccessful femoral head replacement, cup arthroplasty or other procedure. | |
| 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. | |
| 4. Correction of function deformity. | |
| 5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques. | |
| The device is intended for cementless use. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K170089 page 1 of 1
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UOC-FDA-047
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్రదేశం
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യ U-Motion II Acetabular System— Additional sizes
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. 2217 |
| Fax Number | +886-3-577156 |
| Name of Contact Person | Gimpel Chien |
| Regulation and Document Management | |
| Date prepared | January 05, 2017 |
| Name of Device | |
| Trade Name | U-Motion II Acetabular System- Additional sizes |
| Common Name | Total hip prostheses |
| Regulation Name and | |
| Number | The device classification for U-Motion II Acetabular |
| System— Additional sizes is “Hip join | |
| metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis” and is contained in the | |
| Code of Federal Regulation, under 21CFR 888.3353. This | |
| falls under the Orthopedic Panel. | |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | LZO, KWY, LWJ, MEH |
| Predicate Device | 1. U-Motion II Acetabular System (K122185) |
- U-Motion II PS+ Cup (K132455) |
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U-Motion II Acetabular System— Additional sizes
Device Description:
This device is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185) and U-Motion II PS+ Cup (K132455). U-Motion II acetabular component includes U-Motion II Cup and U-Motion II XPE Cup Liner. The indications, materials, design, safety and effectiveness of U-Motion II Cup and Cup Liner are identical to the cleared U-Motion II Acetabular System (K122185) and U-Motion II PS* Cup (K132455) except the dimension. The subject U-Motion II Cups are available in size Ø 50 mm and Ø 46 mm O.D. and the subject U-Motion II Cup Liners are available in 32 mm and 36 mm I.D. The 32 mm and 36 mm inserts fit the acetabular shells with 46 mm O.D. and 50 mm O.D., respectively.
Indications:
The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
-
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
-
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
-
- Correction of functional deformity.
- Treatment of nonunion femoral neck and trochanteric fracture of the proximal 5. femur with head involvement that is unmanageable using other techniques.
The device is intended for cementless use.
Comparison to Predicate Device:
U-Motion II Acetabular System— Additional sizes has the same basic design, intended use, materials and the same manufacturing method as device of the U-Motion II Acetabular System (K122185) and U-Motion II PS+ Cup (K132455).
5
യ U-Motion II Acetabular System— Additional sizes
Performance Data:
The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device is not the worst case within all sizes of U-Motion II Acetabular System. These adding sizes would not affect the safety and effectiveness.