(260 days)
Not Found
No
The document describes a hip implant system and its components, focusing on materials, dimensions, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for "reduction or relief of pain and/or improved hip function" and for "correction of functional deformity," which are therapeutic outcomes.
No
The document describes an implantable medical device for hip replacement, which is a therapeutic intervention rather than a diagnostic tool.
No
The device description clearly states it includes physical components (U-Motion II Cup and U-Motion II XPE Cup liner) which are implants.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "single use implant" consisting of an acetabular cup and liner, intended for surgical implantation in the hip.
- Intended Use: The intended use describes the device's purpose as reducing pain and improving hip function in patients with specific hip conditions, which is achieved through surgical implantation, not through testing bodily samples.
The information provided describes a surgical implant, not a diagnostic test performed outside the body.
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, 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 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.
This device is a single use implant and intended for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The subject device, U-Motion II Acetabular System—Extension line, is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185, K132455, K170089 and K172833). The subject device includes two components: U-Motion II Cup and U-Motion II XPE Cup liner. The indication, design rationale, material, major manufacture process and sterilization method of these two components are identical to the cleared U-Motion II Cup (K122185, K132455, K170089, and K172833) and U-Motion II XPE Cup Liner (K122185 and K170089), except for the dimension.
U-Motion II Cup
The cleared U-Motion II Cup is available from 44 through 80 mm outer diameter (O.D.) in 2 mm increments. The subject U-Motion II Cup is available in 48 mm O.D. and 54 mm O.D. and the compatible liner diameter is 36 mm and 40 mm, respectively, which is larger than the cleared cups. It is designed to only be compatible with the subject cup liner.
U-Motion II XPE Cup Liner
The cleared U-Motion II XPE Cup Liner is available in 28 mm, 32 mm, 36 mm, and 40 mm inner diameter (I.D.). The subject XPE Cup Liner is available in 36 mm I.D. and 40 mm I.D., and is compatible with the subject 48 mm O.D. cup. and 54 mm O.D. cup, 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the modification items of the design rationale of the Subject device, the following tests were conducted to evaluate the safety and effectiveness of the subjected device, and the test results indicated that this device is safe and effective.
Impingement analysis
Range of motion
Jumping distance analysis
Wear simulation test
Locking strength test
Cup deformation test
Cup fatigue test
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.
K122185, K132455, K170089, K172833, K111546, K983382
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.
Not Found
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
§ 888.3353 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 5, 2023
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 Taiwan
Re: K221149
Trade/Device Name: U-Motion II Acetabular System-Extension line 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 Dated: December 7, 2022 Received: December 7, 2022
Dear Lois 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K221149
Device Name
U-Motion II Acetabular System-Extension line
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:
-
Painful, disabling joint disease of the hip resulting from: degenerative 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 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.
This device is a single use implant and intended for cementless use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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O U-Motion II Acetabular System—Extension line
Traditional 510 (k)
510(K) SUMMARY Traditional 510(k)
[as required by 21 CFR 807.92(c)]
Submitter information
| Company Name: | United Orthopedic Corporation |
|---|---|
| Address | No 57, Park Ave 2, Science Park, Hsinchu City 30075, Taiwan |
| Telephone | +886-3-5773351 ext. 2220 |
| Fax | +886-3-577156 |
| Contact Person | Lois Ho, Regulatory Affairs Manager |
|---|---|
| Email address | lois.ho@unitedorthopedic.com |
| Date of submission | April 18, 2022 |
Trade Name, Common Name, Classification
| Device Common Name: | Acetabular Component |
|---|---|
| Trade name: | U-Motion II Acetabular System—Extension line |
| Submitter Establishment Number: | 9681642 |
| Classification Regulation Number: | 21CFR 888.3353 |
| Classification Panel: | Orthopedic |
| Product Code: | LZO |
| Device Class: | Class II |
| Classification name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
Predicate devices
| Product name | Manufacturer | 510(k) Number |
|---|---|---|
| Primary Predicate | ||
| U-Motion II Acetabular System | United Orthopedic Corporation | K122185 |
| Additional Predicates | ||
| U-Motion II PS+ Cup | K132455 | |
| U-Motion II Acetabular System— | ||
| Additional sizes | K170089 | |
| E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation | K172833 |
| U2 Hip System | K111546 | |
| Osteonics® HA Generation II Acetabular Component System | Osteonics Corporation | K983382 |
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© U-Motion II Acetabular System—Extension line
| Device description | The subject device, U-Motion II Acetabular System—Extension line, is an
extension in terms of additional size to the previously cleared U-Motion II
Acetabular System (K122185, K132455, K170089 and K172833). The subject
device includes two components: U-Motion II Cup and U-Motion II XPE Cup
liner. The indication, design rationale, material, major manufacture process and
sterilization method of these two components are identical to the cleared U-Motion
II Cup (K122185, K132455, K170089, and K172833) and U-Motion II XPE Cup
Liner (K122185 and K170089), except for the dimension. | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | U-Motion II Cup
The cleared U-Motion II Cup is available from 44 through 80 mm outer diameter
(O.D.) in 2 mm increments. The subject U-Motion II Cup is available in 48 mm
O.D. and 54 mm O.D. and the compatible liner diameter is 36 mm and 40 mm,
respectively, which is larger than the cleared cups. It is designed to only be
compatible with the subject cup liner. | |
| | U-Motion II XPE Cup Liner
The cleared U-Motion II XPE Cup Liner is available in 28 mm, 32 mm, 36 mm,
and 40 mm inner diameter (I.D.). The subject XPE Cup Liner is available in 36
mm I.D. and 40 mm I.D., and is compatible with the subject 48 mm O.D. cup. and
54 mm O.D. cup, respectively. | |
| 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.
This device is a single use implant and intended for cementless use only. | |
| Technological
Characteristics | The Subject device fundamental scientific principles and technological
characteristics, including: the intended use, material and general design, are the
same as, or similar to, the primary predicate and the chosen additional
predicate/reference devices.
Summary of the technological characteristics: Intended use: identical Indications for Use, Anatomical sites, operating principles and conditions of
use are identical No new risks associated to the Subject device compared to those of the
predicate devices. Verification activities on subject devices demonstrated equivalent safety and
effectiveness as compared to the predicate devices. Material: are identical to the primary predicate. | |
| U-Motion II Acetabular System—Extension line | | Traditional 510 (k) |
| ✓ Geometry and size: thickness of the subject liner is the worst-case and has
been demonstrated equivalent safety and effectiveness as compared to the
predicate devices.
✓ Sterilization: identical method as predicates.
The technological characteristics of the Subject device are substantially
equivalent to the predicate device(s). | | |
| Performance Analysis | Based on the modification items of the design rationale of the Subject device, the
following tests were conducted to evaluate the safety and effectiveness of the
subjected device, and the test results indicated that this device is safe and effective.
Impingement analysis Range of motion Jumping distance analysis Wear simulation test Locking strength test Cup deformation test Cup fatigue test | |
| Conclusion | Based upon equivalences in: intended use, patient population, site of application,
conditions of use, operating principles, and the non-clinical performance data,
the Subject device has been shown to be safe and effective and to perform
equivalently as compared to the legally marketed predicate devices.
Therefore, the Subject devices are substantially equivalent to the legally
marketed predicate devices. | |
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