(205 days)
Not Found
No
The summary describes a mechanical knee implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the reduction or relief of pain and/or improved knee function, which are therapeutic goals.
No
The device is described as "designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia," which indicates it is a prosthetic device used for treatment (surgical implantation) rather than for diagnosing a condition.
No
The device description clearly details physical components made of titanium alloy and UHMWPE, which are hardware implants for knee replacement surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in knee arthroplasty for the reduction or relief of pain and improved knee function. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as components for replacing bearing and articulating surfaces of the proximal tibia, made of materials like titanium alloy and UHMWPE. These are physical implants designed to be surgically placed within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device described is a surgical implant used in knee replacement surgery.
N/A
Intended Use / Indications for Use
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The subjected device is designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia composed of an articulating bearing surface fixed in a metal tibial baseplate, and is used for patients in primary or revision surgery who require augmentation and/or stem extensions due to inadequate bone stock. This premarket notification includes the following components: U2 Tibial Baseplate-CMA type, #7 Tibial Insert (CR/PS), #7 XPE Tibial Insert (CR/PS) and #7 Tibial Augment.
U2 Tibial Baseplate-CMA (Cemented Modular Augmentation) is manufactured from titanium alloy forging (ASTM F620) which is forged by titanium alloy bars (ASTM F136) with seven proportional sizes (#1 to #7). Tibial Insert and XPE insert, including PS type and CR type, is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640, K103733). It is manufactured from UHMWPE (ASTM F648/ISO 5834) with five available thicknesses (9, 11, 13, 15, and 18 mm). Tibial Augment is an additional size extension to the previously cleared "UNITED" U2 Total Knee System-PSA Type (K082424, K122183). It is manufactured from Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) with three available thicknesses (5, 10, 15mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective.
- Locking Strength of Tibial Insert a.
- Contact Area and Contact Pressure b.
- Wear Simulation C.
- d. Range of Motion
- e. Fatigue Test of Tibial Baseplate
- f. Fatigue Test of Tibial Insert Spine
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.
K051640, K103733, K082424, K122183, K991581
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
§ 888.3560 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
(9) U2 Tibial Baseplate- CMA type, Tibial Insert and Augment 510(k) Summary
510(k) Summary of Safety and Effectiveness
JAN 1 5 2014
| Submitted by: | 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 |
| Date of Summary: | June 21, 2013 |
| Contact Person | Fang-Yuan Ho |
| Regulation and Document Management | |
| Proprietary Name: | U2 Tibial Baseplate- CMA type, Tibial Insert and Augment |
| Common Name: | Semi-constrained total knee prostheses |
| Device Classification | Knee joint patellofemorotibial polymer/metal/polymer |
| Name and Reference: | semi-constrained cemented prosthesis per 21CFR 888.3560. |
| This falls under the Orthopedics panel. | |
| Device Class | Class II |
| Panel Code | Orthopaedics Device |
| Device Product Code: | JWH |
| Predicate Device: | 1. "UNITED" U2 Total Knee System (K051640) |
| 2. "UNITED" U2 XPE Total Knee System (K103733) | |
| 3. "UNITED" U2 Total Knee System-PSA Type (K082424) | |
| 4. "UNITED" Augment and Screw, PSA Type (K122183) | |
| 5. "ZIMMER" NexGen Complete Knee Solution L.P.S. Flex |
Device Description:
The subjected device is designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia composed of an articulating bearing surface fixed in a metal tibial baseplate, and is used for patients in primary or revision surgery who require
Fixed Bearing Knee (K991581)
.UOC-FDA-027
Page: 7-1/3
1
(9) U2 Tibial Baseplate- CMA type, Tibial Insert and Augment 510(k) Summary
augmentation and/or stem extensions due to inadequate bone stock. This premarket notification includes the following components: U2 Tibial Baseplate-CMA type, #7 Tibial Insert (CR/PS), #7 XPE Tibial Insert (CR/PS) and #7 Tibial Augment.
U2 Tibial Baseplate-CMA (Cemented Modular Augmentation) is manufactured from titanium alloy forging (ASTM F620) which is forged by titanium alloy bars (ASTM F136) with seven proportional sizes (#1 to #7). Tibial Insert and XPE insert, including PS type and CR type, is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640, K103733). It is manufactured from UHMWPE (ASTM F648/ISO 5834) with five available thicknesses (9, 11, 13, 15, and 18 mm). Tibial Augment is an additional size extension to the previously cleared "UNITED" U2 Total Knee System-PSA Type (K082424, K122183). It is manufactured from Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) with three available thicknesses (5, 10, 15mm).
Indications:
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.
Basis for Substantial Equivalence:
Tibial Baseplate- CMA a.
The Tibial Baseplate- CMA has the same basic design, intended use, materials and the same manufacturing method as the tibial baseplate of the "United" U2 Total Knee System
2
(9) U2 Tibial Baseplate- CMA type, Tibial Insert and Augment 510(k) Summary
and "United" U2 Total Knee System-PSA. Like the "United" U2 Total Knee System-PSA, the Tibial Baseplate- CMA can be used with extension stem and augments. Besides, the Tibial Baseplate- CMA has the same basic design, intended use, material as the tibial plate of "Zimmer" NexGen Complete Knee Solution L.P.S. Flex Fixed Knee.
Tibial Insert b.
Tibial Insert, including PS type and CR type, is an additional size extension of tibial insert of the previously cleared "UNITED" U2 Total Knee System (K051640), while the subjected XPE insert is an additional size extension of the previously cleared "UNITED" U2 XPE Total Knee System (K103733). The materials, design, manufacturing process of the tibial insert and XPE insert are identical to the cleared tibial inserts of "UNITED" U2 Total Knee System and "UNITED" U2 XPE Tibial Inset, respectively.
Tibial Augment c.
Tibial augment—screw locking is an additional size extension to the previously cleared "UNITED" U2 Total Knee System - PSA Type (K082424, K122183). The materials, design, manufacturing process of this device are identical to the cleared tibial inserts of "UNITED" U2 Total Knee System-PAS type.
Performance Data:
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective.
- Locking Strength of Tibial Insert a.
- Contact Area and Contact Pressure b.
- Wear Simulation C.
- d. Range of Motion
- e. Fatigue Test of Tibial Baseplate
- f. Fatigue Test of Tibial Insert Spine
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2014
United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager No. 57, Park Avenue 2, Science Park Hsinchu, 300 TAIWAN
Re: K131864
Trade/Device Name: U2 Tibial Baseplate-CMA type, Tibial Insert and Augment 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: December 5, 2013 Received: December 11, 2013
Dear Fang-Yuan 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 Part 801); medical device reporting (reporting of medical
4
Page 2 -- Fang-Yuan Ho
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also.plcase 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincercly yours.
Ronald和剑ean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
K131864 510 (k) Number (if known):
Device Name: U2 Tibial Baseplate- CMA type, Tibial Insert and Augment
Indications for Use:
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.
Prescription Use ___x Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Orthopedic Devices