(28 days)
No
The document describes a hip implant and its mechanical properties, with no mention of AI or ML in its design, function, or testing.
Yes
The device is described as being used for the "reduction or relief of pain and/or improved hip function" and for treating various painful and disabling joint conditions, which aligns with the definition of a therapeutic device.
No
The device, U-Motion II PS Cup, is an acetabular system intended for hip replacement and pain relief, indicating a therapeutic or reconstructive purpose rather than diagnosing diseases.
No
The device description clearly states it is a physical implant made of titanium alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for the reduction or relief of pain and improved hip function in patients with various hip conditions. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an acetabular cup, a component of a hip replacement prosthesis. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a surgical implant used to treat a condition directly.
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 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 femur with head involvement that is unmanageable using other techniques.
The device is intended for cementless use.
Product codes
LZO, LWJ, KWY, MEH
Device Description
U-Motion II PS Cup is an extension of cleared "UNITED" U-Motion II Acetabular System (K122185). The indications, major design features, materials, major manufacture processing and methods, size distribution of this subject are identical to the cleared U-Motion II Acetabular System (K122185). This device is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars (ASTM F136). The outer surface of U-Motion II PS+ Cup is coated with CP Ti power (ASTM F1580), and the coating layer is thicker than the cleared U-Motion II PS Cup (K122185). U-Motion II PS* Cup includes cluster-holed, no-hole and multi-hole series, and there are nineteen sizes of acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments.
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
Prescription Use
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 the modified surface have been evaluated to conform to FDA guidance: "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA" and "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement." The analysis results demonstrate that the coating fayer thickness increase would not affect the safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
"UNITED" U-Motion II Acetabular System (K122185)
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 text "U-Motion II PS+ Cup". The text is written in a simple, sans-serif font. The word "U-Motion" is followed by "II PS+ Cup". There is a logo to the left of the text.
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: | August 02, 2013 | SEP 0 3 2013 | |
| Contact Person | Fang-Yuan Ho | ||
| Regulation and Document Management Manager | |||
| Proprietary Name: | U-Motion II PS+ Cup | ||
| Common Name: | Acetabular Cup | ||
| Device Classification | Hip joint metal/ceramic/polymer semi-constrained cemented | ||
| Name and Reference: | or nonporous uncemented prosthesis under 21CFR 888.3353 | ||
| This falls under the Orthopedics panel. | |||
| Device Class | Class II | ||
| Panel Code | Orthopaedics Device | ||
| Device Product Code: | LZO, LWJ, KWY, MEH | ||
| Predicate Device: | "UNITED" U-Motion II Acetabular System (K122185) |
Device Description:
U-Motion II PS Cup is an extension of cleared "UNITED" U-Motion II Acetabular System (K122185). The indications, major design features, materials, major manufacture processing and methods, size distribution of this subject are identical to the cleared U-Motion II Acetabular System (K122185). This device is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars (ASTM F136). The outer surface of U-Motion II PS+ Cup is coated with CP Ti power (ASTM F1580), and the coating layer is thicker than the cleared U-Motion II PS Cup (K122185). U-Motion II PS* Cup includes cluster-holed, no-hole and multi-hole series, and there are nineteen sizes of
UOC-FDA-030
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1
ਤੇ U-Motion II PS+ Cup
acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments.
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 femur with head involvement that is unmanageable using other techniques.
The device is intended for cementless use.
Basis for Substantial Equivalence:
The indications, materials, geometry, size distribution and sterilization method of U-Motion II PS Cup are identical to the predicate device "UNITED" U-Motion II Acetabular Cup (K122185).
Performance Data:
The mechanical properties of the modified surface have been evaluated to conform to FDA guidance: "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA" and "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement." The analysis results demonstrate that the coating fayer thickness increase would not affect the safety and effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 symbol that resembles a human figure embracing or supporting another form, possibly representing health and well-being.
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
September 3, 2013
United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager No 57, Park Avenue 2, Science Park Hsinchu 300 Taiwan
Re: K132455 Trade/Device Name: U-Motion II PS* Cup 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, LWJ, KWY, MEH Dated: August 2, 2013 Received: August 6, 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, 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
3
Page 2 - Fang-Yuan Ho
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.
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/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/dcfault.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/ResourcesforYou/Industry/default.htm.
Sincercly yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
K132455 510 (k) Number (if known): _
Device Name: __ U-Motion II PS+ Cup __
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 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 femur with head involvement that is unmanageable using other techniques.
The device is intended 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 L. Frank -S
Page 1 of 1
Division of Orthopedic Devices
UOC-FDA-030
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