(197 days)
No
The document describes a mechanical knee implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an augment and screw for knee arthroplasty, used in patients with severe knee pain and disability, which directly treats a medical condition.
No
The device is an implant for knee arthroplasty, specifically augments and screws, and its purpose is therapeutic (to treat severe knee pain and disability by replacing parts of the knee joint), not diagnostic.
No
The device description explicitly states that the device is made of Co-Cr-Mo alloy and Ti-6Al-4V alloy, which are physical materials used in knee implants. It also describes physical components like femoral and tibial augments and screws. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for knee arthroplasty to address structural issues and pain in the knee joint. This is a therapeutic and structural intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a physical implant made of metal alloys, designed to be attached to other knee replacement components and fixed with cement. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance study described focuses on the mechanical strength of the device components, which is relevant to a surgical implant's function, not a diagnostic test's accuracy.
In summary, the device is a surgical implant used in knee replacement surgery, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This device is indicated in knee arthroplasty 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 is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
"UNITED" Augment and Screw - PSA Type, including femoral augments - distal only and tibial augments, is an extension of cleared "UNITED" U2 Total Knee System -PSA Type (K082424). The raw materials, safety and effectiveness of this subject device are identical to the "UNITED" U2 Total Knee System - PSA Type (K082424), except for increasing their thickness and modifying the shape to mimic anatomy.
Femoral augment - distal only made of Co-Cr-Mo alloy (ASTM F75 or ASTM F1537) are available in 12 mm and 16 mm thickness and can be positioned on either side of femoral component. This component is only available distally. Tibial augments are made of Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) and with 15 mm thickness. The periphery of the distal end of tibial augments is larger than that of the proximal end. It is left/right specific. The femoral augments and tibial augments are sized to match the femoral components and tibial base plates, respectively. There are 6 sizes (sizes #1 through 6) to match the corresponding augmentable femoral components - PSA type and tibial baseplates - PSA type (K082424). The augments are affixed to the tibial and femoral components with screw fixation and that the implant construct as a whole is to be fixed with cement. This device should not be used with another manufacturer's total knee systems since dimensional compatibility cannot be assured. It also should not be used with U2 Total Knee System - PS Type and CR Type. For total knee replacement, "UNITED" patella components (K021657, K051640, K082469, and K103733) are intended to be used with U2 Total Knee System - PSA Type (K082424) and the subject device.
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)
The locking strength evaluation between femoral component and femoral augment, as well as tibial baseplate and tibial augment completed as part of the design assurance process, demonstrated that this device is substantially equivalent to the predicate device.
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.
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.
K021657, K051640, K082469, K103733
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
Augment and Screw, PSA Type
. 510(k) Summary
510(k) Summary of Safety and Effectiveness
| 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: | +886-3-5777156 |
| Date of Summary: | July 20, 2012 |
| Contact Person | Fang-Yuan Ho |
| Regulation and Document Management | |
| Proprietary Name: | Augment and Screw, PSA Type |
| Common Name: | Knee System Augments |
| 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 - PSA Type (K082424) |
- "Zimmer" NexGen Complete Knee Solution Legacy CCK Type (K960279)
- "BIOMET" Vanguard 360 Revision Knee System |
(K093293)
Device Description:
"UNITED" Augment and Screw - PSA Type, including femoral augments - distal only and tibial augments, is an extension of cleared "UNITED" U2 Total Knee System -PSA Type (K082424). The raw materials, safety and effectiveness of this subject device
Page: Summary-1/3
1
Augment and Screw, PSA Type
510(k) Summary
are identical to the "UNITED" U2 Total Knee System - PSA Type (K082424), except for increasing their thickness and modifying the shape to mimic anatomy.
Femoral augment - distal only made of Co-Cr-Mo alloy (ASTM F75 or ASTM F1537) are available in 12 mm and 16 mm thickness and can be positioned on either side of femoral component. This component is only available distally. Tibial augments are made of Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) and with 15 mm thickness. The periphery of the distal end of tibial augments is larger than that of the proximal end. It is left/right specific. The femoral augments and tibial augments are sized to match the femoral components and tibial base plates, respectively. There are 6 sizes (sizes #1 through 6) to match the corresponding augmentable femoral components - PSA type and tibial baseplates - PSA type (K082424). The augments are affixed to the tibial and femoral components with screw fixation and that the implant construct as a whole is to be fixed with cement. This device should not be used with another manufacturer's total knee systems since dimensional compatibility cannot be assured. It also should not be used with U2 Total Knee System - PS Type and CR Type. For total knee replacement, "UNITED" patella components (K021657, K051640, K082469, and K103733) are intended to be used with U2 Total Knee System - PSA Type (K082424) and the subject device.
Indications
This device is indicated in knee arthroplasty 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
UOC-FDA-023
Page: Summary-2/3
2
ತಿ Augment and Screw, PSA Type
510(k) Summary
valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
Basis for Substantial Equivalence:
The intended uses, materials, locking mechanism design and sterilization method of femoral augments - distal only are similar to the femoral augments of U2 Total Knee System - PSA Type (K082424) and "Zimmer" NexGen Complete Knee Solution Legacy CCK Type (K960279). The differences between these three devices are 1) thickness, 2) geometry, and 3) the femoral screw length and its threaded length.
The intended uses, substrate materials, locking mechanism design and sterilization method of tibial augments are similar to the tibial augments of U2 Total Knee System -PSA Type (K082424) and "BIOMET" Vanguard 360 Revision Knee System (K093293). The differences between these three devices are 1) thickness, 2) geometry, and 3) edge taper.
Performance Data:
The locking strength evaluation between femoral component and femoral augment, as well as tibial baseplate and tibial augment completed as part of the design assurance process, demonstrated that this device is substantially equivalent to the predicate device.
Page: Summary-3/3
3
Letter dated: February 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
United Orthopedic Corporation % Ms. Fang-Yuan Ho Regulatory Affairs, Manager No. 57, Park Avenue 2, Science Park Hsinchu, 300 Taiwan
Re: K122183
Trade/Device Name: Augment and Screw, PSA Type 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 20, 2012 Received: December 26, 2012
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
4
Page 2 - Ms. Fang-Yuan Ho
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Augment and Screw, PSA Type
Indications for Use:
This device is indicated in knee arthroplasty 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 is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Anton E. Dmitriev, PhD | 2013.02.05 10:03:47 |
|---|---|
| Division of Orthopedic Devices | -05'00' |
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