(59 days)
No
The summary describes a mechanical orthopedic implant and its variations, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical implant intended for hip arthroplasty to treat painful and/or disabled joints and fractures, which directly addresses a medical condition and restores function.
No
Explanation: The device is described as a "Conformity stem" used in hip arthroplasty, indicating it is an orthopedic implant for treatment, not for diagnosing conditions.
No
The device description clearly states it is an "extension line" of a "Conformity stem, cementless" device, which is a physical implant used in hip arthroplasty. The performance studies also describe physical tests like fatigue assessments and coating characterization, indicating a hardware component.
Based on the provided information, 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 description clearly states that this device is a femoral stem used in hip arthroplasty. This is a surgical implant designed to be placed inside the body to replace a damaged hip joint.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- 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.
Product codes
LZO, MEH
Device Description
The subject device is an extension line of 510(K) cleared device Conformity stem, cementless (K183312, K242249), which introduces four new variations: (1) Conformity stem, #0; (2) Conformity stem, collared, #0; (3) Conformity stem, coxa vara, 125° STD, collared, #0; and (4) Conformity stem, short neck, collared #0. The indications, design rationales, materials, manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312, K242249).
Conformity Stem can collocate with “United” metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).
- Conformity stem, #0
Conformity stem, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity Stem, #1, #11 (K183312)The only differences in the items are the offset specifications and stem length. - Conformity stem, collared, #0
- Conformity stem, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, collared, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity stem, collared, #1, #11 (K183312).The only differences in the items are the offset specifications and stem length.
- Conformity Stem, coxa vara, 125° STD, collared, #0
- Conformity Stem, coxa vara, 125° STD, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, coxa vara 125° STD, collared, #1-7 (K242249). The material, coating thickness, neck angle (125°), and neck length (32.5mm) design are identical to 510 (k) cleared device Conformity stem, 125° STD, collared, #1, #7 (K242249). The only differences in the items are the offset specifications and stem length.
- Conformity Stem, short neck, collared #0
- Conformity Stem, short neck, collared #0 is an extension in terms of sizes to 510 (k) cleared device Conformity Stem, short neck, collared, #1-7 (K183312 and K242249). The material, coating thickness, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, collared, #1, #7 (K183312 and K242249). The only differences in the items are the offset specifications and stem length.
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
Non-Clinical and/or Clinical Tests Summary & Conclusions: Based on the design rationale of the Subject device, the following tests were conducted to evaluate the safety and effectiveness of the subject device.
• Range of Motion (ISO 21535)
• Neck Fatigue Assessment (ISO 7206-6)
• Stem Fatigue Test (ISO 7206-4)
• Characterization of HA Plasma Spray Coating (FDA guidance “510(k) information needed for Hydroxyapatite Coated Orthopedic Implants")
• Usability Evaluation (BS EN 62366-1, FDA guidance "Content of Human Factors Information in Medical Device Marketing Submissions"," Applying Human Factors and Usability Engineering to Medical Devices.")
Based upon equivalence 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 be substantially equivalent to the legally marketed predicate devices. Therefore, the Subject device is substantially equivalent to the legally marketed predicate devices.
Key Metrics
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
January 6, 2025
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu. 30075 Taiwan
Re: K243466
Trade/Device Name: Conformity Stem Extension Line, #0 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: October 28, 2024 Received: November 8, 2024
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 (the 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 available 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
ges that may require a new premarket notification are provided in the FDA
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
RYAN TROMBETTA -S
For: 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
3
Indications for Use
Submission Number (if known)
K243466
Device Name
Conformity Stem Extension Line, #0
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, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
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.
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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4
Traditional 510(k) Conformity Stem Extension line, #0
Image /page/4/Picture/2 description: The image shows the logo for United Orthopedic. The logo consists of a green circle with a white dot in the center, resembling the letter 'U'. To the right of the circle, the words 'UNITED ORTHOPEDIC' are written in black, with a small registered trademark symbol next to the word 'ORTHOPEDIC'.
510(K) SUMMARY
Traditional 510(k)
[as required by 21 CFR 807.92(c)]
Contact Details
| Applicant Name | United Orthopedic Corporation |
|---|---|
| Applicant Address | No 57, Park Ave 2, Science Park, Hsinchu City 30075, Taiwan |
| Applicant Contact | |
| Telephone | +88635773351 |
| Applicant Contact | Mrs. Lois Ho |
| Applicant Contact Email | lois.ho@unitedorthopedic.com |
Device Name
| Device Trade Name | Conformity Stem Extension Line, #0 |
|---|---|
| Common Name | Hip Stem |
| Classification Name | Hip joint metal/ceramic/polymer semi-constrained cemented |
| or nonporous uncemented prosthesis | |
| Regulation Number | 888.3353 |
| Product Codes | LZO, MEH |
Predicate Device Information
| 510(k) Number | Predicate Trade Name | Product Code |
|---|---|---|
| K183312 (Primary predicate) | Conformity stem, cementless | LZO, MEH |
| K242249 | Conformity stem extension line | LZO, MEH |
| Device Description
Summary | The subject device is an extension line of 510(K) cleared
device Conformity stem, cementless
(K183312, K242249), which introduces four new variations: (1)
Conformity stem, #0; (2) Conformity stem, collared, #0; (3)
Conformity stem, coxa vara, 125° STD, collared, #0; and (4)
Conformity stem, short neck, collared #0. The indications,
design rationales, materials, manufacturing process, and
sterilization method of the subject devices are identical to the
510(k) cleared Conformity Stem, cementless (K183312,
K242249).
Conformity Stem can collocate with “United” metallic femoral
heads (K994078, K022520, K111546, K122504, K152439,
K162957, K221675) or ceramic femoral heads (K103497,
K112463, K122185). |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Conformity stem, #0 |
| | Conformity stem, #0 is an extension in terms of sizes to 510 |
| | (k) cleared device Conformity stem, #1-11 (K183312). The
material, coating thickness, neck angle (135°), and neck
length (35.5mm) design are identical to 510 (k) cleared device
Conformity Stem, #1, #11 (K183312)The only differences in
the items are the offset specifications and stem length. |
| | - Conformity stem, collared, #0 |
| | - Conformity stem, collared, #0 is an extension in terms of sizes
to 510 (k) cleared device Conformity stem, collared, #1-11
(K183312). The material, coating thickness, neck angle (135°),
and neck length (35.5mm) design are identical to 510 (k)
cleared device Conformity stem, collared, #1, #11
(K183312).The only differences in the items are the offset
specifications and stem length. |
| | - Conformity Stem, coxa vara, 125° STD, collared, #0 |
| | - Conformity Stem, coxa vara, 125° STD, collared, #0 is an
extension in terms of sizes to 510 (k) cleared device
Conformity stem, coxa vara 125° STD, collared, #1-7
(K242249). The material, coating thickness, neck angle (125°),
and neck length (32.5mm) design are identical to 510 (k)
cleared device Conformity stem, 125° STD, collared, #1, #7
(K242249). The only differences in the items are the offset
specifications and stem length. |
| | - Conformity Stem, short neck, collared #0 |
| | - Conformity Stem, short neck, collared #0 is an extension in
terms of sizes to 510 (k) cleared device Conformity Stem, short
neck, collared, #1-7 (K183312 and K242249). The material,
coating thickness, neck angle (135°), and neck length
(28.5mm) design are identical to 510 (k) cleared device
Conformity Stem, short neck, collared, #1, #7 (K183312 and
K242249). The only differences in the items are the offset
specifications and stem length. |
| 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,
traumatic arthritis, rheumatoid arthritis, or congenital hip
dysplasia. - 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. |
5
Traditional 510(k)
Conformity Stem Extension line, #0
Image /page/5/Picture/2 description: The image contains the logo for United Orthopedic. The logo consists of a green circular icon with a white "U" shape inside, followed by the words "UNITED" and "ORTHOPEDIC" stacked on top of each other. The word "ORTHOPEDIC" is followed by the registered trademark symbol.
6
Traditional 510(k)
Conformity Stem Extension line, #0
Image /page/6/Picture/2 description: The image contains the logo for United Orthopedic. The logo consists of a green circular icon with a white "U" shape inside, followed by the words "UNITED" and "ORTHOPEDIC" stacked on top of each other in black, sans-serif font. A registered trademark symbol is present next to the word "ORTHOPEDIC".
| Indications for Use
Comparison | The indication for use of the subject device is identical to the
predicate devices. |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Comparison | The technological characteristics of the subject device are
substantially equivalent to those of the predicate device
Conformity stem, cementless (K183312) and Conformity stem
extension line (K242249) as per the comparison given below:
- Their intended use is the same.
- The material, principle of operation, regulation number,
product code, risk class, intended users, fixation method,
surface coating, locking mechanism, and sterilization method
of the subject device are the same as those of the predicate
device. - Verification activities were conducted to assess the
differences in the offset specifications and the stem length
sizes between the subject and predicate, using the same
analysis methods as the predicate submission. |
| Non-Clinical and/or
Clinical Tests
Summary &
Conclusions | Based on the design rationale of the Subject device, the
following tests were conducted to evaluate the safety and
effectiveness of the subject device.
• Range of Motion (ISO 21535)
• Neck Fatigue Assessment (ISO 7206-6)
• Stem Fatigue Test (ISO 7206-4)
• Characterization of HA Plasma Spray Coating
(FDA guidance “510(k) information needed for Hydroxyapatite
Coated Orthopedic Implants")
• Usability Evaluation
(BS EN 62366-1, FDA guidance "Content of Human Factors
Information in Medical Device Marketing Submissions","
Applying Human Factors and Usability Engineering to Medical
Devices.")
Based upon equivalence 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 be substantially equivalent to the legally marketed
predicate devices.
Therefore, the Subject device is substantially equivalent to the
legally marketed predicate devices. |