(259 days)
No
The description focuses on the material, design, and mechanical properties of a hip stem, with no mention of AI or ML capabilities.
Yes.
The device is indicated for use in hip arthroplasty to treat severe pain and/or disability from various conditions, thus restoring function and alleviating symptoms.
No
This device is a hip implant, specifically a "Conformity stem, cemented," used in hip arthroplasty to replace damaged hip joints. Its purpose is treatment and reconstruction, not diagnosis. The "Intended Use / Indications for Use" section lists conditions that lead to the need for joint replacement, not conditions that the device diagnoses.
No
The device description clearly states it is a "triple tapered, polished, collarless stem" manufactured from Co-Cr-Mo alloy, which is a physical implant.
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. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a "Conformity stem, cemented" used in "hip arthroplasty." This is a surgical implant designed to replace a damaged hip joint.
- Mechanism of Action: The device functions as a mechanical component within the body to restore hip function. It does not analyze biological samples.
The provided information describes a surgical implant, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dyplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacment or total hip replacement.
- Certain cases of ankylosis.
Conformity stem, cemented is for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LZO, KWY
Device Description
The "United" Conformity stem, cemented is a triple tapered, polished, collarless stem. It is available in various sizes with standard and high offset types to accommodate various hip surgical requirements. Conformity stem, cemented is manufactured from Co-Cr-Mo alloy which conform to ASTM F799-11 (Raw material: ASTM F1537-11/ISO 5832-12:2007). It is intended to be fixed only with the use of PMMA bone cement and should be used with "United" Cement restrictor.
For total hip arthroplasty, Conformity stem, cemented can be used with "United" acetabular liner, cup and femoral head. For bipolar hip replacement, Conformity stem, cemented 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
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 Performance: The mechanical properties of this device have been evaluated, the taper of the subject device is identical to the predicate, and that finite element method (FEM) analysis was used to determine that no additional stem or neck fatigue testing was needed, and the ROM simulation results are substantially equivalent to the legally marketed device and meet the requirement of ISO 21535. In addition, bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP . Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
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.
"United" UCP stem (K152530)
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.
"United" U2 Hip Stem (K003237)
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".
January 3, 2020
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu City, 30075 Tw
Re: K191056
Trade/Device Name: Conformity stem, cemented Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI Dated: December 4, 2019 Received: December 6, 2019
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.
1
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) 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.
Vesa Vuniqi Acting 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
2
Indications for Use
510(k) Number (if known) K191056
Device Name Conformity stem, cemented
Indications for Use (Describe)
The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:
-
A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dyplasia.
-
Avascular necrosis of the femoral head.
-
Acute traumatic fracture of the femoral head or neck.
-
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacment or total hip replacement.
-
Certain cases of ankylosis.
Conformity stem, cemented is 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)
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.qov
"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."
3
Image /page/3/Picture/0 description: The image shows the logo for United Orthopedic Corporation. The logo features a green circular shape with a white oval inside, resembling the letter 'U'. To the right of the symbol, the word "United" is written in gray, with the words "Orthopedic Corporation" in a smaller font below it, also in gray. A registered trademark symbol is located to the right of the word "United".
United Orthopedic Corporation
Office: 12F., No.80, Sec. 1, Chenggong Rd., Yonghe Dist., New Taipei City 23452, Taiwan Tel:+886 2 2929-4567 Hsinchu Plant: No. 57, Park Ave. 2, Science Park, Hsinchu City 30075, Taiwan Tel:+886 3 577-3351 Kaohsiung Plant: No.16,Luke 1st Rd., Luzhu Dist., Kaohsiung City 82151, Taiwan Tel:+886 7 695-5850
K191056 Page 1/3
510(k) Summary
| Submitter Information | |
|---|---|
| Name | United Orthopedic Corporation |
| Address | No 57, Park Ave 2, Science Park, Hsinchu City 30075, |
| Taiwan | |
| Phone Number | +886-3-5773351 ext. 2220 |
| Fax Number | +886-3-577156 |
| Name of Contact Person | Lois Ho, Regulatory Affairs Manager |
| Date prepared | April 15, 2019 |
| Device Information | |
| Trade Name | Conformity stem, cemented |
| Common Name | Hip stem |
| Classification Name | Hip joint metal/polymer semi-constrained cemented |
| prosthesis (21 CFR 888.3350) | |
| Device Class | Class II |
| Classification Panel | Orthopedics |
| Product Code | JDI, LZO, KWY |
| Predicate Device | "United" UCP stem (K152530) |
| Reference Device | "United" U2 Hip Stem (K003237) |
UOC-FDA-053 Each Step We Care Page: 1/3
4
Image /page/4/Picture/0 description: The image shows the logo for United Orthopedic Corporation. The logo features a green circular icon with a white circle inside, resembling the letter 'U'. To the right of the icon, the word "United" is written in gray, with the words "Orthopedic Corporation" written in a smaller font size below it.
K191056 Paqe 2/3
Office: 12F., No.80, Sec. 1, Chenggong Rd., Yonghe Dist., New Taipei City 23452, Taiwan Tel:+886 2 2929-4567
Hsinchu Plant: No. 57, Park Ave. 2, Science Park, Hsinchu City 30075, Taiwan Tel:+886 3 577-3351
Kaohsiung Plant: No. 16, Luke 1st Rd., Luzhu Dist., Kaohsiung City 82151, Taiwan Tel:+886 7 695-5850
Device Description:
The "United" Conformity stem, cemented is a triple tapered, polished, collarless stem. It is available in various sizes with standard and high offset types to accommodate various hip surgical requirements. Conformity stem, cemented is manufactured from Co-Cr-Mo alloy which conform to ASTM F799-11 (Raw material: ASTM F1537-11/ISO 5832-12:2007). It is intended to be fixed only with the use of PMMA bone cement and should be used with "United" Cement restrictor.
For total hip arthroplasty, Conformity stem, cemented can be used with "United"acetabular liner, cup and femoral head. For bipolar hip replacement, Conformity stem, cemented can be used with "United" bipolar prosthesis.
Indications for Use:
The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dyplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
-
- Certain cases of ankylosis.
Conformity stem, cemented is for cemented use only.
Image /page/4/Picture/15 description: The image contains the text "UOC-FDA-053" in the upper left corner. The phrase "Each Step We Care" is prominently displayed, with "Each Step" in black and "We Care" in green. The text appears to be a logo or slogan.
5
K191056 Page 3/3
Image /page/5/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo consists of a green circular shape with a white circle inside, resembling the letter 'U'. To the right of the symbol is the word "United" in gray, with the words "Orthopedic Corporation" in a smaller font below it. There is a registered trademark symbol to the right of the word "United".
d Orthonedir (
Office: 12F., No.80, Sec. 1, Chenggong Rd., Yonghe Dist., New Taipei City 23452, Taiwan Tel:+886 2 2929-4567
Hsinchu Plant: No. 57, Park Ave. 2, Science Park, Hsinchu City 30075, Taiwan Tel:+886 3 577-3351
Kaohsiung Plant: No. 16, Luke 1st Rd., Luzhu Dist., Kaohsiung City 82151, Taiwan Tel:+886 7 695-5850
Comparison to Predicate Device:
The "United" Conformity stem, cemented is substantially equivalent to "United" UCP stem (K152530) in indication for use, material, manufacturing processes, design rationale and sterilization method.
The difference between the subject and the predicate devices is size distribution. 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, Conformity stem, cemented is substantially equivalent to the predicate devices.
Performance Data:
● Non-clinical Performance
The mechanical properties of this device have been evaluated, the taper of the subject device is identical to the predicate, and that finite element method (FEM) analysis was used to determine that no additional stem or neck fatigue testing was needed, and the ROM simulation results are substantially equivalent to the legally marketed device and meet the requirement of ISO 21535.
In addition, bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP .
Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.