(239 days)
Not Found
No
The description focuses solely on the materials, design, and mechanical function of the knee resurfacing prosthesis. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a partial replacement for the articulating surfaces of the knee, which is a medical intervention intended to treat diseased or damaged body parts.
No
Explanation: This device is a prosthesis used for partial replacement of knee articulating surfaces, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components made of metal alloys and polyethylene, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The provided text describes a surgical implant designed to be placed inside the human body to replace damaged parts of the knee joint.
- Intended Use: The intended use clearly states it's a "partial replacement of the articulating surfaces of the knee." This is a surgical procedure, not an in vitro test.
The device is a medical device, specifically a prosthetic implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Unicompartmental Knee Resurfacing Prosthesis (UniCAP ™) is indicated for use as a partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSX
Device Description
The Unicompartmental Knee Resurfacing Prosthesis (UniCAP™) incorporates a low-profile femoral articular component that mates to a taper post via a taper interlock. The femoral resurfacing component articulates against an allpolyethylene tibial resurfacing component. The UniCAP™ implants allow resurfacing of the compartment utilizing the undisturbed compartmental structures and soft-tissues.
The femoral articular component is manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The femoral articular component has a bone contact surface that is coated with a spray-applied CP Titanium coating (identical to sponsor's previously approved devices) and a xpolished articular bearing surface.
The taper post component is a cylindrical threaded stem 20mm in length, manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The post has a tapering major and minor diameter, a full-length cannulation, and a proximal female taper bore.
The tibial resurfacing component is comprised of ultra high molecular weight polyethylene (UHMWPE) manufactured and tested to meet standards specified in ASTM D 648. The tibial component is offered in a range of thickness ( 6.0 mm, 6.5 mm, 7.0 mm and 7.5 mm) accommodate a variety of tibial surface conditions.
The components have been designed to allow a minimum amount of bone and soft tissue resection. The UniCAP™ system offers the surgeon a high degree of precision and flexibility in sizing and fitting the articular components to the existing anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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)
Not Found
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.
K880155, K954186, K033769, K032824
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
510(K) Summary of Safety and Effectiveness (21 CFR 807.92) [21 CFR 807.87(h)]
Unicompartmental Knee Resurfacing Prosthesis (UniCAP™)
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.87(h), this information serves as a Summary of Safety and Effectiveness for the Unicompartmental Knee Resurfacing Prosthesis (UniCAP™).
| Submitted By: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Phone: (508) 520-3003
Fax: (508) 528-4604 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 3, 2005 |
| Contact Person: | Steven W. Ek, Chief Operations Officer |
| Proprietary Name: | Unicompartmental Knee Resurfacing Prosthesis
(UniCAP™) |
| Common Name: | Knee joint femorotibial metal/polymer non-
constrained cemented prosthesis |
| Device Classification: | Class II |
| Review Panel: | Orthopedic |
| C.F.R. identification
reference: | 21 CFR § 888.3520 (2004) |
| Product Code: | HSX |
| Indications for Use: | Partial replacement of the articulating surfaces of
the knee when only one side of the joint is affected
due to the compartmental primary degenerative or
post-traumatic degenerative disease, previous
tibial condyle or plateau fractures, deformity or
revision of previous arthroplasty. This device is
intended to be used with bone cement. |
1
Substantial Equivalence Information:
The Arthrosurface Unicompartmental Knee Resurfacing Prosthesis (UniCAP™) has been compared with the following legally marketed devices to which the sponsor claims substantial equivalence:
- Miller/Galante Precoat Unicompartmental Knee System (Zimmer, Inc.) 제 (K880155)
- Link® Endo-Model™ Sled Uni-Knee System, (Link America, Inc). . (K954186)
- EUIS® Unicompartmental Knee System (Howmedica Osteonics) l (K033769)
- Stelkast Unicondylar Knee System (Stelkast Co.) (K032824)
Device Description Summary
The Unicompartmental Knee Resurfacing Prosthesis (UniCAP™) incorporates a low-profile femoral articular component that mates to a taper post via a taper interlock. The femoral resurfacing component articulates against an allpolyethylene tibial resurfacing component. The UniCAP™ implants allow resurfacing of the compartment utilizing the undisturbed compartmental structures and soft-tissues.
The femoral articular component is manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The femoral articular component has a bone contact surface that is coated with a spray-applied CP Titanium coating (identical to sponsor's previously approved devices) and a xpolished articular bearing surface.
The taper post component is a cylindrical threaded stem 20mm in length, manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The post has a tapering major and minor diameter, a full-length cannulation, and a proximal female taper bore.
The tibial resurfacing component is comprised of ultra high molecular weight polyethylene (UHMWPE) manufactured and tested to meet standards specified in ASTM D 648. The tibial component is offered in a range of thickness ( 6.0 mm, 6.5 mm, 7.0 mm and 7.5 mm) accommodate a variety of tibial surface conditions.
The components have been designed to allow a minimum amount of bone and soft tissue resection. The UniCAP™ system offers the surgeon a high degree of precision and flexibility in sizing and fitting the articular components to the existing anatomy.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, INC." is arranged around the upper portion of the circle.
0CT 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William Ciavarra Director, Quality Assurance & Regulatory Affairs Arthrosurface, Inc. 28 Forge Parkway Franklin, Massachusetts 02038
Re: K050373
Trade/Device Name: Unicompartmental Knce Resurfacing Prosthesis (UniCAPTM) Regulation Number: 21 CFR 888.3520 Regulation Name: Knec joint femorotibial metal/polymer non constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: September 21, 2005 Received: September 22, 2005
Dear Mr. Ciavarra:
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 rcclassified 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 complics 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); good manufacturing practice requirements as set
3
Page 2 -- Mr. William Ciavarra
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rooduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This leket will and in your he FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ectoral International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 长 050 3 9 3
Device Name: Unicompartmental Knee Resurfacing Prosthesis (C.A.P.)™
Indications for Use:
The Unicompartmental Knee Resurfacing Prosthesis (UniCAP ™) is indicated for use as a partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.
Prescription Usc (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices |
Page of __
Posted November 13, 2003
| 510(k) Number | K050373 |
|---|---|
| --------------- | --------- |
(P