(30 days)
No
The document describes a hip stem implant and its variations, focusing on materials, design, and mechanical testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a femoral stem intended for use in hip arthroplasty to treat severely painful and/or disabled hip joints due to various conditions, which are therapeutic interventions.
No
This device is a hip implant (a Conformity Stem) used in hip arthroplasty, which is a surgical procedure to replace a damaged hip joint. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a femoral stem manufactured from Ti-6Al-4V alloy and coated with hydroxyapatite, which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation in the hip joint to treat various conditions affecting the joint itself. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details a femoral stem made of Ti-6Al-4V alloy with a hydroxyapatite coating, designed for cementless use in hip arthroplasty. This is a physical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.
- Performance Studies: The performance studies described are mechanical analyses (Range of Motion, Neck fatigue, Stem fatigue), which are relevant to the structural integrity and function of an implantable device, not to diagnostic accuracy.
Therefore, this device falls under the category of a surgical implant for hip replacement, 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH
Device Description
The "United" Conformity Stem cementless type (K183312) is designed 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-6Al-4V alloy, which conforms 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 "United" Conformity Stem cementless is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.
For the subject device, it's an extension line of the 510(K) cleared device Conformity Stem cementless type (K183312), which introduces two new variations: (1) Conformity stem, coxa vara, 125° STD, collared, #1-7; and (2) Conformity stem, short neck, #4-7. The indications, design rationales, materials, major manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312).
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, coxa vara, 125° STD, collared
Conformity stem, coxa vara, 125° STD, collared is a new coxa vara type variation of 510(k) cleared Conformity stem, coxa vara (1110-52XX, K183312). The same as this 510(k) cleared device, it's also made of Ti-6Al-4V alloy (ASTM F136), and the distal part is coated with hydroxyapatite(HA) (ASTM F1185). In addition, the subject device is also a collared stem with a 125° neck angle. The only difference is the offset design. The subject device is standard offset, while the 510(k) cleared coxa vara collared stem (110-52XX) is high offset -
Conformity Stem, short neck, #4-7
Conformity stem, short neck, #4-7 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, short neck, #1-3 (K183312). The design, material, coating thickness, geometrical characteristics, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, #1-3 (K183312). The only different is the stem length sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip Joint
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)
Mechanical Analyses
- Range of Motion (ROM) evaluation per ISO 21535
- Neck fatigue analysis per ISO 7206-6
- Stem fatigue analysis per ISO 7206-4
No clinical tests were performed to support the safety and efficacy of the subject device.
The mechanical analyses were used as a basis for the determination of substantial equivalence. The results of each show that compared to the predicate device, the subject device has met the required acceptance criteria, and there are no additional risks arising. Thus, the Conformity extension line is considered substantially equivalent to the predicate devices (K183312).
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.
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 textual information provided in the document.
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 contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
August 30, 2024
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu. 30075 Taiwan
Re: K242249
Trade/Device Name: Conformity Stem 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, MEH Dated: July 30, 2024 Received: July 31, 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.
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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 (QS) 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.
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.
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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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Indications for Use
Submission Number (if known)
Device Name
Conformity Stem Extension Line
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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United Orthopedic Corporation
Conformity Stem Extension line
Contact Details
| Applicant Name | United Orthopedic Corporation |
|---|---|
| Applicant Address | No 57, Park Ave 2, Science Park, Hsinchu City 30075, Taiwan |
| Applicant Contact | |
| Telephone | +886-3-5773351 |
| Applicant Contact | Mrs. Lois Ho |
| Applicant Contact Email | lois.ho@unitedorthopedic.com |
Device Name
| Device Trade Name | Conformity Stem Extension line |
|---|---|
| Common Name | Hip joint metal/ceramic/polymer semi-constrained cemented |
| or nonporous uncemented prosthesis | |
| Classification Name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, |
| Cemented Or Non-Porous, Uncemented | |
| Regulation Number | 888.3353 |
| Product Codes | LZO, MEH |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name | Product Code |
|---|---|---|
| K183312 | Conformity stem, cementless | LZO, MEH |
| Device Description | ||
| Summary | The "United" Conformity Stem cementless type (K183312) is | |
| designed 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-6Al-4V alloy, which | ||
| conforms 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 "United" Conformity Stem | ||
| cementless is available in various sizes with collarless and | ||
| collared types to accommodate various hip surgical | ||
| requirements. | ||
| For the subject device, it's an extension line of the 510(K) | ||
| cleared device Conformity Stem cementless type (K183312), | ||
| which introduces two new variations: (1) Conformity stem, | ||
| coxa vara, 125° STD, collared, #1-7; and (2) Conformity stem, | ||
| short neck, #4-7. The indications, design rationales, materials, | ||
| major manufacturing process, and sterilization method of the | ||
| subject devices are identical to the 510(k) cleared Conformity | ||
| Stem, cementless (K183312). | ||
| 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, coxa vara, 125° STD, collared | ||
| Conformity stem, coxa vara, 125° STD, collared is a new coxa | ||
| vara type variation of 510(k) cleared Conformity stem, coxa | ||
| vara (1110-52XX, K183312). The same as this 510(k) cleared | ||
| device, it's also made of Ti-6Al-4V alloy (ASTM F136), and the | ||
| distal part is coated with hydroxyapatite(HA) (ASTM F1185). In | ||
| addition, the subject device is also a collared stem with a 125° | ||
| neck angle. The only difference is the offset design. The | ||
| subject device is standard offset, while the 510(k) cleared coxa | ||
| vara collared stem (110-52XX) is high offset | ||
| - Conformity Stem, short neck, #4-7 | ||
| Conformity stem, short neck, #4-7 is an extension in terms of | ||
| sizes to 510 (k) cleared device Conformity stem, short neck, | ||
| #1-3 (K183312). The design, material, coating thickness, | ||
| geometrical characteristics, neck angle (135°), and neck length | ||
| (28.5mm) design are identical to 510 (k) cleared device | ||
| Conformity Stem, short neck, #1-3 (K183312). The only | ||
| different is the stem length sizes. | ||
| 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.
Conformity stem is for cementless use only. | |
| 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 is
substantially equivalent to that of the predicate device
Conformity stem, cementless (K183312) as the comparison
given below.
- Their intended use is the same.
- The design, material, principle of operation, regulation
number, product code, risk class, intended users, fixation
method, surface coating, geometry design, locking mechanism
of stem locking, and sterilization method of the subject device
is the same as that of the predicate device. - The design control activities were conducted for the
difference in the offset specification and the stem length sizes.
They validated equivalent safety and effectiveness compared
to the predicate devices based on the same analysis method
the previous submission applied.
It established that no new risks arise compared to those of the
predicate devices. | |
| Non-Clinical and/or
Clinical Tests Summary
& Conclusions | Mechanical Analyses - Range of Motion (ROM) evaluation per ISO 21535
- Neck fatigue analysis per ISO 7206-6
- Stem fatigue analysis per ISO 7206-4
No clinical tests were performed to support the safety and
efficacy of the subject device.
The mechanical analyses were used as a basis for the
determination of substantial equivalence. The results of each
show that compared to the predicate device, the subject
device has met the required acceptance criteria, and there are
no additional risks arising. Thus, the Conformity extension line
is considered substantially equivalent to the predicate devices
(K183312). | |
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