United U2 femoral head, 22mm delta ceramic head

K221675 · United Orthopedic Corporation · LPH · Nov 4, 2022 · Orthopedic

Device Facts

Record IDK221675
Device NameUnited U2 femoral head, 22mm delta ceramic head
ApplicantUnited Orthopedic Corporation
Product CodeLPH · Orthopedic
Decision DateNov 4, 2022
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3358
Device ClassClass 2
AttributesTherapeutic

Intended Use

The device is indicated for use in hip arthroplasty in patients with the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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 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.

Device Story

The United U2 femoral head is a 22mm delta ceramic implant designed for hip arthroplasty. It serves as a size extension to the previously cleared U2 Femoral Head (K162957). The device is manufactured from zirconia-toughened alumina ceramic and is available in +1, +3, and +5 mm neck lengths. It is intended to articulate with the U2 Bipolar Implant (22mm I.D.) and may be used with various United titanium hip stems. The device is implanted by orthopedic surgeons in a clinical setting to replace a damaged femoral head, restoring joint function and reducing pain for patients with degenerative or traumatic hip conditions. It is a single-use implant. The device is inserted using standard orthopedic instrumentation.

Clinical Evidence

No clinical data was provided. Safety and effectiveness were demonstrated through bench testing, including burst strength, fatigue, post-fatigue burst strength (ISO 7206-10, ASTM F2345-03), pull-off strength (ASTM F2009), torque-off strength (ISO 7206-13), range of motion (ISO 21535), and pull-out/lever-out strength from the bipolar head.

Technological Characteristics

Material: Zirconia-toughened alumina ceramic. Form factor: 22mm femoral head with +1, +3, +5 mm neck lengths. Principle: Articulating hip prosthesis component. Standards: ISO 7206-10, ISO 7206-13, ISO 21535, ASTM F2345-03, ASTM F2009. Sterilization: Identical to primary predicate. Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients requiring hip arthroplasty due to osteoarthritis, traumatic/rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture of femoral head/neck, or failed previous hip surgery. In the USA, restricted to use with hemi (bipolar) implants.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{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: 1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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 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 888.3358<br>21CFR 888.3390 | | Classification Panel: | Orthopedic | | Product Code: | LPH<br>KWY | | Device Class: | Class II | | Classification name: | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis<br><br>Hip joint femoral (hemi-hip) metal/polymer cemented or<br>uncemented 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 Femoral<br>Head (K162957). The design, manufacturer, materials, manufacturing progress,<br>sterilization of this subject are identical or similar to its primary and additional<br>predicates. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Ceramic femoral head, delta, 22mm (Subject device) is manufactured from<br>zirconia-toughened alumina ceramic is available in +1, +3 and +5 mm of neck<br>length. This device is intended to articulate with U2 Bipolar Implant, 22mm<br>I.D (K152439) and can be used in conjunction with United titanium Hip Stem.<br>Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti porous coated Stem<br>(K003237, K151316), Ti Press-fit Stem (K111546), Revision Hip Stem<br>(K062978), UTS Stem (K172251), UTF Stem (K110245, K163193, K123550,<br>K132207) and Conformity stem (K183312). The size extension does not affect<br>the intended use or alter the fundamental scientific technology of the device. | | | Surgical procedures with the use of the subject device shall be performed<br>with the support of orthopedic instrumentation, to facilitate their proper<br>insertion and removal from the patient. | | Indications for use | The device is indicated for use in hip arthroplasty in patients with the following<br>conditions: 1. A severely painful and/or disabled joint from osteoarthritis,<br>traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia.<br>2. Avascular necrosis of the femoral head.<br>3. Acute traumatic fracture of the femoral head or neck.<br>4. Failed previous hip surgery.<br>This device is a single use implant and intended for cementless use only except<br>cemented stem which is designed for cemented use only.<br>In the USA: United U2 femoral head, 22mm delta ceramic head is only<br>indicated for use with the hemi (bipolar) implant. | | Technological<br>Characteristics | The Subject device fundamental scientific principles and technological<br>characteristic, including: the intended use, material and general design,<br>are the same as, or similar to, the primary predicate and the chosen additional<br>predicate devices.<br>Summary of the technological characteristics:<br>✓ Intended use: identical to primary predicate<br>✓ Indications for Use, Anatomical sites, operating principles and<br>conditions of use are similar<br>✓ No new risks associated to the subject device compared to those<br>of the predicate devices.<br>✓ Verification activities on subject device demonstrated substantially<br>equivalent safety and effectiveness as compared to the<br>predicate devices.<br>✓ Material: are identical to the additional ceramic predicates.<br>✓ Geometry and size: similar<br>✓ Sterilization: identical method as primary predicate.<br>The technological characteristics of the subject device are substantially<br>equivalent to the predicate device(s). | | Performance Analysis | Based on the introduction of the subject device, safety and effectiveness were<br>evaluated through the following engineering analysis to demonstrate substantial<br>equivalence to the predicate devices:<br>Burst strength, fatigue and post-fatigue burst strength of femoral head from stem<br>(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-<br>determined acceptance criteria identified in the Design Control Activities<br>demonstrating that the subject component performs as safely and effectively<br>compared to the predicate components, and is substantially equivalent to the<br>legally marketed predicate devices | {5}------------------------------------------------
Innolitics
510(k) Summary
Decision Summary
Classification Order
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