(200 days)
No
The document describes a mechanical knee implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "Knee Resurfacing System" intended to provide "increased patient mobility and reduced pain by replacing the damaged knee joint articulation," which directly addresses a health condition (damaged knee joint) and aims to restore function and alleviate symptoms.
No
Explanation: The device is a knee resurfacing system, which is a prosthetic implant used to replace damaged knee joint articulations, not to diagnose medical conditions.
No
The device description clearly states it is composed of physical components like femoral components, tibial components, and patellar components made of materials like Co-Cr-Mo and UHMWPE, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant designed to replace a damaged knee joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the physical components of the knee resurfacing system (femoral components, tibial components, patellar components) which are surgically implanted.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sigma High Performance Unity Knee Resurfacing System is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The Sigma High Performance Unity Knee Resurfacing System is indicated for single or multicompartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All Sigma High Performance Unity Knee Resurfacing System components are intended for CEMENTED USE ONLY.
Product codes
HRY, NPJ
Device Description
The Sigma High Performance Unity Knee Resurfacing System is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create: a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee; two unicompartmental femorotibial replacements for both the medial and lateral sides of the knee; a patellofemoral replacement; a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee; or a tricompartmental patellofemorotibial replacement for the medial and lateral sides of the knee.
This submission adds metal-backed unicompartmental tibial components to the previously cleared GCK System. The Sigma High Performance Unity Knee Resurfacing System metalbacked unicompartmental tibial components consist of wrought forged Co-Cr-Mo unicompartmental tibial trays and XLK cross-linked UHMWPE unicompartmental tibial inserts. The trays and inserts are available in 6 sizes and in left medial / right lateral and right medial / left lateral configurations. Each tibial insert is available in 5 thicknesses. The Sigma High Performance Unity Knee Resurfacing System metal-backed unicompartmental tibial components are intended for use with the previously cleared GCK unicompartmental femoral components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint / Tibiofemoral and/or patellofemoral articular surfaces
Indicated Patient Age Range
skeletally mature individuals
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 Testing:
Engineering analysis, wear simulator testing and mechanical testing were performed to demonstrate the substantial equivalence of the Sigma High Performance Unity Knee Resurfacing System mctal-backed unicompartmental tibial components to the predicate devices.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the subject Sigma High Performance Unity Knee Resurfacing System Tibial Components and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
3. 510(K) SUMMARY
| Applicant / Sponsor: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Establishment Registration No.: 1818910 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nancy Friddle
Team Leader, Regulatory Affairs
Tel: (574) 371-4923
Fax: (574) 371-4987 |
| Proprietary Name: | Sigma High Performance Unity Knee Resurfacing
System |
| Common Name: | Compartmental Knee Prosthesis System |
| Classification Name: | 21 CFR 888.3530: Knee joint femorotibial,
metal/polymer semi-constrained cement prosthesis, Class
II |
| Product Codes: | HRY, NPJ |
| Substantially
Equivalent Devices: | DePuy GCK (K061648) |
| | DePuy Preservation Unicondylar Knee (K040268) |
| | DePuy Sigma Unicompartmental Knee, submitted as the
J&J PFC Unicondylar Knee System (K910968) |
Device Description:
The Sigma High Performance Unity Knee Resurfacing System is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create: a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee; two unicompartmental femorotibial replacements for both the medial and lateral sides of the knee; a patellofemoral replacement; a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee; or a tricompartmental patellofemorotibial replacement for the medial and lateral sides of the knee.
1
K070267
This submission adds metal-backed unicompartmental tibial components to the previously cleared GCK System. The Sigma High Performance Unity Knee Resurfacing System metalbacked unicompartmental tibial components consist of wrought forged Co-Cr-Mo unicompartmental tibial trays and XLK cross-linked UHMWPE unicompartmental tibial inserts. The trays and inserts are available in 6 sizes and in left medial / right lateral and right medial / left lateral configurations. Each tibial insert is available in 5 thicknesses. The Sigma High Performance Unity Knee Resurfacing System metal-backed unicompartmental tibial components are intended for use with the previously cleared GCK unicompartmental femoral components.
Intended Use:
The Sigma High Performance Unity Knee Resurfacing System is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Indications for Use:
The Sigma High Performance Unity Knee Resurfacing System is indicated for single or multicompartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All Sigma High Performance Unity Knee Resurfacing System components are intended for CEMENTED USE ONLY.
Summary of Technologies/Substantial Equivalence:
The Sigma High Performance Unity Knee Resurfacing System metal-backed unicompartmental tibial components have the same indications and intended use, a similar design and the same articulating geometry as the previously cleared GCK all polyethylene unicompartmental tibial The manufacturing materials are identical to materials that have been components. previously cleared in other DePuy knee prostheses.
Non-Clinical Testing:
Engineering analysis, wear simulator testing and mechanical testing were performed to demonstrate the substantial equivalence of the Sigma High Performance Unity Knee Resurfacing System mctal-backed unicompartmental tibial components to the predicate devices.
2
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\xi & \ddots & \xi
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\bullet & \bullet & \omega \circ \alpha
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Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the subject Sigma High Performance Unity Knee Resurfacing System Tibial Components and the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a human figure or a symbol related to health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Nancy Friddle Team Leader, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
AUG 1 7 2007
K070267 Trade/Device Name: Sigma High Performance Unity Knee Resurfacing System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY, NPJ Dated: May 23, 2007 Received: May 25, 2007
Dear Ms. Friddle:
Re:
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.
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 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); 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.
4
Page 2 - Ms. Nancy Friddle
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Barbara Schneider Romm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
2. INDICATIONS FOR USE
510(k) Number (if known): _ \ 0 7 0 26 7
Device Name: Sigma High Performance Unity Knee Resurfacing System
Indications for Use:
The Sigma High Performance Unity Knee Resurfacing System is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All Sigma High Performance Unity Knee Resurfacing System components are intended for CEMENTED USE ONLY.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchanan
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number_K070267