(230 days)
No
The summary describes a passive implant (tibial component) made of UHMWPE with an embedded X-ray marker. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies are focused on mechanical properties and wear, not algorithmic performance.
Yes
The device is a total knee arthroplasty implant, intended to treat various knee conditions and restore joint function, which is a therapeutic purpose.
No
Explanation: The device is an implantable knee prosthesis, which is used for treatment (total knee arthroplasty) and not for diagnosing a condition.
No
The device description clearly states it is a physical implant made of UHMWPE with an embedded metal wire, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description clearly states that this device is an "All Poly Tibial Component" which is a single use implant made of UHMWPE and intended for cemented use in total knee arthroplasty. This is a surgical implant, not a device used to test bodily specimens.
- Intended Use: The intended use describes the conditions for which the device is indicated in total knee arthroplasty, which is a surgical procedure.
- No Mention of Specimen Testing: There is no mention of collecting, preparing, or testing any bodily specimens.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions: 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 2. Collagen disorders, and/or avascular necrosis of the femoral condyle. 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. 4. Moderate valgus, varus, or flexion deformities. 5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component.
This device is a single use implant and intended for cemented use only.
Product codes
JWH
Device Description
All Poly Tibial Components are made of Ultra High Molecular Weight Polyethylene (UHMWPE), including Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. All types are available in sizes #0~#7 (ranging from 39.5mm/60mm AP/ML to 58mm/84mm AP/ML) with ten thickness options (9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm). The CR type of All Poly Tibial Component is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The PS type and UC type are intended to be used in situation where the posterior cruciate ligament is absent or cannot be preserved. All Poly Tibial Components can be used with femoral components of U2 Total Knee System and patella (K021657, K103733, K051640 and K082469) in primary or revision total knee arthroplasty. CR and UC types are designed to collocate with CR femoral component (K140073, K150829, K140075 and K150832) while PS type is designed to collocate with PS femoral component (K051640, K120507 and K150829). The X-ray marking wire which is made of Co-20Cr-15W-10Ni alloy is embedded in the All Poly Tibial Component for X-ray image identification purpose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
knee
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)
Non-clinical Performance: This 510(k) submission was prepared in accordance with the Agency's, "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA". Tests as follows were conducted to evaluate the safety and effectiveness of the subject device, and the test results demonstrated the subject device is substantially equivalent to the predicate device.
- a. Range of Motion
- Contact Area and Contact Pressure b.
- Constraint Test C.
- d. Wear Simulation Test
- Fatigue Test e.
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974556, K962152, K051640, K131864, K132752
Reference Device(s)
K021657, K103733, K051640, K082469, K140073, K150829, K140075, K150832, K051640, K120507, K150829
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
United Orthopedic Corporation Karen Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu. 300 TAIWAN
April 12, 2016
Re: K152430 Trade/Device Name: All Poly Tibial Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 14, 2016 Received: March 17, 2016
Dear Ms. 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. 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 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152430
Device Name All Poly Tibial Component
Indications for Use (Describe)
The device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions: 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
-
Collagen disorders, and/or avascular necrosis of the femoral condyle.
-
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
-
Moderate valgus, varus, or flexion deformities.
-
The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component.
This device is a single use implant and intended for cemented 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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3
510(k) Summary of Safety and Effectiveness
Submitter Information
| Name | United Orthopedic Corporation |
|---|---|
| Address | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan |
| Phone Number | +886-3-5773351 ext. 2212 |
| Fax Number | +886-3-577156 |
| Name of Contact Person | Karen Ho |
| Regulation and Document Management | |
| Date prepared | March 10, 2016 |
| Name of Device | |
| Trade Name | All Poly Tibial Component |
| Common Name | Total Knee Prosthesis |
| Regulation Name and | |
| Number | Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis under 21CFR §888. | |
| 3560 | |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | JWH |
| Predicate Device | 1. “OSTEONICS” Osteonics® ScorpioTM Posterior |
| Cruciate Retaining Total Knee System (K974556) |
- “OSTEONICS” Osteonics® ScorpioTM Posteriorly
Stabilized Total Knee System (K962152) - “UNITED” U2 Total Knee System (K051640, K131864
- “UNITED” Ultracongruent Insert (K132752) |
Device Description:
All Poly Tibial Components are made of Ultra High Molecular Weight Polyethylene
4
(9) All Poly Tibial Component
(UHMWPE), including Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. All types are available in sizes #0~#7 (ranging from 39.5mm/60mm AP/ML to 58mm/84mm AP/ML) with ten thickness options (9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm). The CR type of All Poly Tibial Component is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The PS type and UC type are intended to be used in situation where the posterior cruciate ligament is absent or cannot be preserved. All Poly Tibial Components can be used with femoral components of U2 Total Knee System and patella (K021657, K103733, K051640 and K082469) in primary or revision total knee arthroplasty. CR and UC types are designed to collocate with CR femoral component (K140073, K150829, K140075 and K150832) while PS type is designed to collocate with PS femoral component (K051640, K120507 and K150829). The X-ray marking wire which is made of Co-20Cr-15W-10Ni alloy is embedded in the All Poly Tibial Component for X-ray image identification purpose.
Indications for Use:
The device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions:
-
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle. 2.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral 3. erosion, dysfunction or prior patellectomy.
-
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory 5. stability in flexion cannot be obtained at the time of surgery.
The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component.
This device is a single use implant and intended for cemented use only.
5
(9) All Poly Tibial Component
Comparison to Predicate Device:
All Poly Tibial Component has the same basic design, intended use and materials as the device, "Osteonics" All-Polyethylene Tibial Component of Osteonics® Scorpio™ Posterior Cruciate Retaining Total Knee System (K974556) and Osteonics® Scorpio TM Posteriorly Stabilized Total Knee System (K962152). The differences between the subject and the predicate devices are the size distribution and sterilization method. However, the performance evaluation of the subject device was conducted and would not post issues about safety and effectiveness. Thus, we believe that the subjected All Poly Tibial Component is substantially equivalent to the predicate device.
Performance Data:
● Non-clinical Performance
This 510(k) submission was prepared in accordance with the Agency's, " Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA". Tests as follows were conducted to evaluate the safety and effectiveness of the subject device, and the test results demonstrated the subject device is substantially equivalent to the predicate device.
- a. Range of Motion
- Contact Area and Contact Pressure b.
- Constraint Test C.
- d. Wear Simulation Test
- Fatigue Test e.
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.