(252 days)
No
The summary describes a mechanical implant (femoral stem) and its material properties and performance testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is a hip implant used to alleviate severe pain and/or disability in patients with various hip conditions, which aligns with the definition of a therapeutic device as it treats a disease or condition.
No
Explanation: The device is a hip implant (femoral stem) used in hip arthroplasty to treat various conditions of the hip joint. It is a therapy device (prosthesis) designed to replace a damaged joint, not a diagnostic device that identifies or assesses a medical condition.
No
The device description clearly describes a physical implant (femoral stem) made of Ti-6A1-4V alloy with a hydroxyapatite coating, and the performance studies focus on mechanical properties and material testing, not software validation.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a hip implant (femoral stem) used in surgical procedures for hip replacement. Its purpose is to replace a damaged hip joint, not to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological specimens. It focuses on the physical properties, materials, and surgical application of the implant.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic device.
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 is for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH
Device Description
The "United" Conformity Stem cementless type is design for cementless use in hip arthroplasty. The Conformity Stem cementless type is a proximal trapezoid and distal quadrangular stem with 12/14 neck taper, 135° and 125° neck angle. It is manufactured from Ti-6A1-4V alloy which conform to ASTM F136-13 and the distal part of each femoral stem is coated with hydroxyapatite (HA) (ASTM F1185-03) to provide biological fixation. The subject device is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.
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:
Tests as follows were conducted to evaluate the safety and effectiveness of the subject device:
- a. Stem fatigue test (ISO 7206-4)
- b. Neck fatigue test (ISO 7206-6)
- c. Range of Motion (ISO 21535)
- d. Fretting Corrosion between Femoral Head and Stem (ASTM F1875 and ISO 7206-4)
- e. Evaluation of Modified Surface Treatment (FDA Guidance Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements)
- Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in f. USP .
Performance data demonstrate the subject 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 results: Based on the information provided, the "United" Conformity Stem is considered substantially equivalence to the predicate device.
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.
"Depuy" Corail ATM Hip Prosthesis (K042992)
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, HA/ Ti plasma spray (K003237), "United" UTF Stem reduced (K132207)
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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August 8, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu. 30075 Tw
Re: K183312
Trade/Device Name: Conformity 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, MEH Dated: July 2, 2019 Received: July 9, 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.
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
1
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 (OS) 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,
FOR 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Conformity Stem
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 is for cementless 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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FORM FDA 3881 (7/17)
UOC-FDA-051
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Image /page/3/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo features a green circular design with a white circle in the center on the left side. To the right of the circular design, the word "United" is written in a bold, dark gray font, and below that, "Orthopedic Corporation" is written in a smaller, lighter gray font.
510(k) Summary (K183312)
| 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 | November 26, 2018 |
| Device Information | |
| Trade Name | Conformity Stem |
| Common Name | Hip Stem |
| Regulation Name and | |
| Number | The device classification for Conformity Stem are “Hip |
| joint metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis” which are contained in | |
| the Code of Federal Regulation, under 21CFR 888.3353 | |
| This falls under the Orthopedic Panel. | |
| Device Class | Class II |
| Classification Panel | Orthopedics |
| Product Code | LZO, MEH |
| Predicate Device | "Depuy" Corail ATM Hip Prosthesis (K042992) |
| Reference Device | "United" U2 Hip Stem, HA/ Ti plasma spray (K003237) |
| "United" UTF Stem reduced (K132207) |
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Image /page/4/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo consists of a green circular shape with a white dot inside, resembling the letter 'U'. To the right of the circular shape, the word "United" is written in bold, dark gray letters. Below "United", the words "Orthopedic Corporation" are written in a smaller, lighter gray font.
Device Description:
The "United" Conformity Stem cementless type is design for cementless use in hip arthroplasty. The Conformity Stem cementless type is a proximal trapezoid and distal quadrangular stem with 12/14 neck taper, 135° and 125° neck angle. It is manufactured from Ti-6A1-4V alloy which conform to ASTM F136-13 and the distal part of each femoral stem is coated with hydroxyapatite (HA) (ASTM F1185-03) to provide biological fixation. The subject device is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.
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 is for cementless use only.
Comparison of Technological Characteristics:
The features of the subject device are comparable to the predicate "Depuy" Corail ATM Hip Prosthesis (K042992) in terms of the indication for use, design rationale, materials, coating and sterilization method except for the size distribution. The differences in size distribution have been validated by stem fatigue testing, neck fatigue testing, range of
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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 "U" inside on the left. To the right of the shape is the word "United" in a bold, dark gray font, with the words "Orthopedic Corporation" in a smaller, lighter gray font underneath.
motion analysis and fretting corrosion analysis to demonstrate that the performance of subject device are substantially equivalence to the predicate device.
Performance Data:
● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subject device:
- a. Stem fatigue test (ISO 7206-4)
- b. Neck fatigue test (ISO 7206-6)
- c. Range of Motion (ISO 21535)
- d. Fretting Corrosion between Femoral Head and Stem (ASTM F1875 and ISO 7206-4)
- e. Evaluation of Modified Surface Treatment (FDA Guidance Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements)
- Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in f. USP .
Performance data demonstrate the subject 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.
Substantial Equivalence Conclusion:
The subject device has the same intended use, materials, coating, sterilization methods, and similar design features as the predicate "Depuy" Corail ATM Hip Prosthesis (K042992). The performance results demonstrate that the subject device is as safe and effective as the legally marketed predicate device. Based on the information provided, the "United" Conformity Stem is considered substantially equivalence to the predicate device.