(148 days)
Not Found
No
The summary describes a physical implant (femoral head) and its compatibility with other hip arthroplasty components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on engineering analyses of mechanical properties.
Yes
The device is a ceramic femoral head, used in hip arthroplasty to replace damaged joint components, directly addressing and alleviating conditions like osteoarthritis and avascular necrosis. It is surgically implanted to restore function and relieve pain.
No
Explanation: The device is described as a "single use implant" and a "Ceramic femoral head" used in hip arthroplasty, which is a therapeutic device, not a diagnostic one. Its intended use is to replace parts of the hip joint.
No
The device description clearly states it is a ceramic femoral head, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in hip arthroplasty in patients with specific conditions affecting the hip joint. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a femoral head, which is a component of a hip implant. Implants are designed to be placed in vivo.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such testing.
The device described is a surgical implant used directly within the patient's body during a hip replacement procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LPH, KWY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
Indicated Patient Age Range
Not Found
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)
Performance Analysis:
Based on the introduction of the subject device, safety and effectiveness were evaluated through the following engineering analysis to demonstrate substantial equivalence 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 Activities demonstrating that the subject component performs as safely and effectively compared to the predicate components, and is substantially equivalent to the legally marketed predicate devices
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.
K162957, K112463, K103497, K180929, K122185
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.
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
§ 888.3358 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.
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
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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.
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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 |
| 21CFR 888.3390 | |
| Classification Panel: | Orthopedic |
| Product Code: | LPH |
| KWY | |
| Device Class: | Class II |
| Classification name: | Hip joint metal/polymer/metal semi-constrained porous-coated |
| uncemented prosthesis |
Hip joint femoral (hemi-hip) metal/polymer cemented or
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 |
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| Device description | 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. |
| Indications for 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,
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 except
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. |
| Technological
Characteristics | The Subject device fundamental scientific principles and technological
characteristic, including: the intended use, material and general design,
are the same as, or similar to, the primary predicate and the chosen additional
predicate devices.
Summary of the technological characteristics:
✓ Intended use: identical to primary predicate
✓ Indications for Use, Anatomical sites, operating principles and
conditions of use are similar
✓ No new risks associated to the subject device compared to those
of the predicate devices.
✓ Verification activities on subject device demonstrated substantially
equivalent safety and effectiveness as compared to the
predicate 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 substantially
equivalent to the predicate device(s). |
| Performance Analysis | Based on the introduction of the subject device, safety and effectiveness were
evaluated through the following engineering analysis to demonstrate substantial
equivalence 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 Activities
demonstrating that the subject component performs as safely and effectively
compared to the predicate components, and is substantially equivalent to the
legally marketed predicate devices |
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