(148 days)
The device is indicated for use in hip arthroplasty in patients with the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery.
This device is a single use implant and intended for cemented stem which is designed for cemented use only.
In the USA: United U2 femoral head, 22mm delta ceramic head is only indicated for use with the hemi (bipolar) implant.
The Subject device is a size extension to the previously cleared U2 Femoral Head (K162957). The design, manufacturer, materials, manufacturing progress, sterilization of this subject are identical or similar to its primary and additional predicates.
Ceramic femoral head, delta, 22mm (Subject device) is manufactured from zirconia-toughened alumina ceramic is available in +1, +3 and +5 mm of neck length. This device is intended to articulate with U2 Bipolar Implant, 22mm I.D (K152439) and can be used in conjunction with United titanium Hip Stem. Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti porous coated Stem (K003237, K151316), Ti Press-fit Stem (K111546), Revision Hip Stem (K062978), UTS Stem (K172251), UTF Stem (K110245, K163193, K123550, K132207) and Conformity stem (K183312). The size extension does not affect the intended use or alter the fundamental scientific technology of the device.
Surgical procedures with the use of the subject device shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided text is a 510(k) summary for a medical device (United U2 femoral head, 22mm delta ceramic head) seeking substantial equivalence to predicate devices. It does not describe an AI medical device or a study involving human readers or a training/test set for an algorithm.
Therefore, most of the requested information regarding AI device performance, expert consensus, MRMC studies, and training/test set details cannot be extracted directly from this document.
However, I can extract the acceptance criteria and performance analysis conducted for this specific medical implant device.
Analysis of the Provided Document (Non-AI Medical Device)
The document describes the performance analysis for a ceramic femoral head (a medical implant) to demonstrate its substantial equivalence to previously cleared devices. The "acceptance criteria" here refer to the predefined standards for the engineering tests conducted on the physical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Conclusion) |
|---|---|
| ISO 7206-10 and ASTM F2345-03 | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Burst strength, fatigue, and post-fatigue burst strength of femoral head from stem. |
| ASTM F2009 | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Pull-off strength of femoral head from stem. |
| ISO 7206-13 | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Torque-off strength of femoral head from stem. |
| ISO 21535 | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Range of motion (ROM). |
| Not explicitly stated standard | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Pull-out strength of femoral head from bipolar head and Lever-out strength of femoral head from bipolar head. (The specific standard for these two tests is not explicitly mentioned but implied to be part of engineering analysis). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "engineering analysis" and testing of "subject components," which typically involves a specific number of physical samples for mechanical tests.
- Data Provenance: Not applicable in the context of an AI device. For this physical implant, the "data" would be the results of the mechanical tests performed in a lab setting. No information about country of origin or retrospective/prospective nature is relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the document describes mechanical testing of a physical implant, not an AI device requiring expert-established ground truth. The "ground truth" here is the physical performance measured against established ISO/ASTM standards.
4. Adjudication method for the test set
- This is not applicable as the document describes mechanical testing of a physical implant, not an AI device for diagnostic or prognostic purposes. The performance is adjudicated against the predefined limits in the engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This document is for a medical implant, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a medical implant, not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this physical medical implant, the "ground truth" implicitly refers to the established mechanical and material performance standards (ISO and ASTM). The device's performance is compared against the limits defined in these engineering standards.
8. The sample size for the training set
- Not applicable. This document is for a medical implant, not an AI device which requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This document is for a medical implant, not an AI device which requires a training set.
Summary for the AI context:
The provided document describes the regulatory clearance for a physical medical implant (femoral head), not an AI medical device. Therefore, the specific information requested about AI acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not present in this text. The "acceptance criteria" discussed are engineering specifications for the mechanical performance of the physical implant, and the "study" is the mechanical engineering analysis and testing.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 4, 2022
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 Taiwan
Re: K221675
Trade/Device Name: United U2 femoral head, 22mm delta ceramic head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH. KWY Dated: October 4, 2022 Received: October 6, 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
{2}------------------------------------------------
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221675
Device Name
United U2 femoral head, 22mm delta ceramic head
Indications for Use (Describe)
The device is indicated for use in hip arthroplasty in patients with the following conditions:
-
A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis or congenital hip dysplasia.
-
Avascular necrosis of the femoral head.
-
Acute traumatic fracture of the femoral head or neck.
-
Failed previous hip surgery.
This device is a single use implant and intended for cemented stem which is designed for cemented use only.
In the USA: United U2 femoral head, 22mm delta ceramic head is only indicated for use with the hemi (bipolar) implant.
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.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."
{3}------------------------------------------------
510(K) SUMMARY
[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 | November 4, 2022 |
Trade Name. Common Name, Classification
| Device Common Name: | Ceramic femoral head prosthesis |
|---|---|
| Trade name: | United U2 femoral head, 22mm delta ceramic head |
| Submitter Establishment Number: | 9681642 |
| Classification Regulation Number: | 21CFR 888.335821CFR 888.3390 |
| Classification Panel: | Orthopedic |
| Product Code: | LPHKWY |
| Device Class: | Class II |
| Classification name: | Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesisHip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis |
Predicate devices
| Predicate | 510(k) Number | Manufacturer |
|---|---|---|
| Primary Predicate | ||
| U2 Femoral Head | K162957 | United Orthopedic Corporation |
| Additional Predicate Devices | ||
| United 36MM Ceramic Femoral Head, Delta | K112463 | United Orthopedic Corporation |
| Ceramic Femoral Head | K103497 | United Orthopedic Corporation |
| Klassic HD® Hip System | K180929 | Total Joint Orthopedics (TJO) |
| U-MOTION II Acetabular System | K122185 | United Orthopedic Corporation |
{4}------------------------------------------------
| Device description | The Subject device is a size extension to the previously cleared U2 FemoralHead (K162957). The design, manufacturer, materials, manufacturing progress,sterilization of this subject are identical or similar to its primary and additionalpredicates. |
|---|---|
| Ceramic femoral head, delta, 22mm (Subject device) is manufactured fromzirconia-toughened alumina ceramic is available in +1, +3 and +5 mm of necklength. This device is intended to articulate with U2 Bipolar Implant, 22mmI.D (K152439) and can be used in conjunction with United titanium Hip Stem.Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti porous coated Stem(K003237, K151316), Ti Press-fit Stem (K111546), Revision Hip Stem(K062978), UTS Stem (K172251), UTF Stem (K110245, K163193, K123550,K132207) and Conformity stem (K183312). The size extension does not affectthe intended use or alter the fundamental scientific technology of the device. | |
| Surgical procedures with the use of the subject device shall be performedwith the support of orthopedic instrumentation, to facilitate their properinsertion and removal from the patient. | |
| Indications for use | The device is indicated for use in hip arthroplasty in patients with the followingconditions: 1. A severely painful and/or disabled joint from osteoarthritis,traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hip surgery.This device is a single use implant and intended for cementless use only exceptcemented stem which is designed for cemented use only.In the USA: United U2 femoral head, 22mm delta ceramic head is onlyindicated for use with the hemi (bipolar) implant. |
| TechnologicalCharacteristics | The Subject device fundamental scientific principles and technologicalcharacteristic, including: the intended use, material and general design,are the same as, or similar to, the primary predicate and the chosen additionalpredicate devices.Summary of the technological characteristics:✓ Intended use: identical to primary predicate✓ Indications for Use, Anatomical sites, operating principles andconditions of use are similar✓ No new risks associated to the subject device compared to thoseof the predicate devices.✓ Verification activities on subject device demonstrated substantiallyequivalent safety and effectiveness as compared to thepredicate devices.✓ Material: are identical to the additional ceramic predicates.✓ Geometry and size: similar✓ Sterilization: identical method as primary predicate.The technological characteristics of the subject device are substantiallyequivalent to the predicate device(s). |
| Performance Analysis | Based on the introduction of the subject device, safety and effectiveness wereevaluated through the following engineering analysis to demonstrate substantialequivalence to the predicate devices:Burst strength, fatigue and post-fatigue burst strength of femoral head from stem(ISO 7206-10 and ASTM F2345-03) Pull-off strength of femoral head from stem (ASTM F2009) Torque-off strength of femoral head from stem (ISO 7206-13) Range of motion (ROM) (ISO 21535) Pull-out strength of femoral head from bipolar head Lever-out strength of femoral head from bipolar head Clinical testing was deemed not necessary for the subject device. |
| Conclusion | Engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activitiesdemonstrating that the subject component performs as safely and effectivelycompared to the predicate components, and is substantially equivalent to thelegally marketed predicate devices |
{5}------------------------------------------------
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.