(239 days)
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.
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.
The provided document is a 510(k) summary for a medical device called the "Unicompartmental Knee Resurfacing Prosthesis (UniCAP™)". This type of document is filed with the FDA to demonstrate substantial equivalence to an already legally marketed device, not to present a study proving a device meets specific acceptance criteria in the way a clinical trial would for performance metrics.
Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/ML device performance or clinical outcomes.
Instead, this document focuses on:
- Substantial Equivalence: Comparing the UniCAP™ device to existing, legally marketed unicompartmental knee systems. The acceptance criteria here are that the new device is as safe and effective as the predicate devices, which is assessed through design, materials, and intended use comparison.
- Device Description: Detailing the materials, components, and design of the UniCAP™ device.
- Indications for Use: Defining the specific conditions and patient populations for which the device is intended.
Since the document is a 510(k) summary for a physical orthopedic implant, it would not include information relevant to AI/ML device testing criteria such as:
- A table of acceptance criteria and the reported device performance: Not applicable for this type of submission. Performance is implied through substantial equivalence to predicate devices, not specific performance metrics against defined acceptance criteria in a study.
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML device.
- Number of experts used to establish the ground truth and their qualifications: Not applicable. There is no ground truth concept for this type of device in this document.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance (algorithm only): Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text is a regulatory filing for an orthopedic implant seeking marketing clearance through substantial equivalence, not a clinical study report or a technical performance evaluation against specific acceptance criteria for an AI/ML device.
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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 ParkwayFranklin, MA 02038Phone: (508) 520-3003Fax: (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. identificationreference: | 21 CFR § 888.3520 (2004) |
| Product Code: | HSX |
| Indications for Use: | Partial replacement of the articulating surfaces ofthe knee when only one side of the joint is affecteddue to the compartmental primary degenerative orpost-traumatic degenerative disease, previoustibial condyle or plateau fractures, deformity orrevision of previous arthroplasty. This device isintended to be used with bone cement. |
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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.
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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
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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
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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
§ 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.