(44 days)
Not Found
No
The summary describes a revision knee system with a material change and does not mention any AI/ML capabilities or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is a knee system indicated for various forms of arthritis and failed knee replacements, which are conditions that require therapeutic intervention.
No
The document describes a Revision Knee System, which is a prosthetic implant used for surgical replacement. It lists indications for use related to arthritic conditions and failed previous replacements, indicating it is a treatment device, not for diagnosis.
No
The device description clearly states it is a "Revision femoral component" made of "cobalt chrome," indicating a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a Revision Knee System, which is a surgical implant used to replace or revise a knee joint. This is a device that is implanted into the body, not used to test specimens from the body.
- Intended Use: The intended use clearly states it's for treating conditions like arthritis and failed knee replacements, which are surgical procedures involving implantation.
Therefore, based on the description and intended use, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Revision Knee System components are indicated for:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The constrained knee systems are designed for use in patients in primary and or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
The Revision Knee components are for single use only and are intended for implantation with bone cement.
Product codes
JWH
Device Description
The LEGION Cobalt Chrome Revision femoral component is a modification of the Revision femoral components cleared via K043440. The subject device is identical in design to the predicate, but the material has been changed from Oxinium, an oxidized zirconium alloy, to cobalt chrome.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
older 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)
A review of the mechanical and clinical data indicated that the LEGION Cobalt Chrome Revision Knee System is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
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.
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
Summary of Safety and Effectiveness
Smith & Nephew, Inc. LEGION Cobalt Chrome Revision Knee System
Contact Person and Address
Date of Summary: March 17, 2006
Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 (901) 399-5520
MAY ર્ 17 11:00
Name of Device: LEGION Cobalt Chrome Revision Knee System Common Name: Knee Prosthesis
Device Description
The LEGION Cobalt Chrome Revision femoral component is a modification of the Revision femoral components cleared via K043440. The subject device is identical in design to the predicate, but the material has been changed from Oxinium, an oxidized zirconium alloy, to cobalt chrome.
Device Classification
21 CFR 888.3560 Knee joint patellofemorotibial polymer semi-constrained knee prosthesis - Class II
Mechanical and Clinical Data
A review of the mechanical and clinical data indicated that the LEGION Cobalt Chrome Revision Knee System is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Intended Use
Revision Knee System components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee components are for single use only and are intended for implantation with bone cement.
Substantial Equivalence Information
The LEGION Cobalt Chrome Revision Knee System components are similar to the following commercially available devices regarding design features, overall indications, and materials:
- Smith & Nephew Revision Knee System (K041106, K043440) 디
- I Zimmer Legacy Constrained Condylar Knee (L-CCK)
- 도 Biomet Oncology Salvage System (OSS)
- 트 Sulzer Orthopedics MOST™ System
510(k) Summary.doc
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2006 MAY
Mr. Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
K060742 Re:
Trade/Device Name: Legion Cobalt Chrome Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: April 27, 2006 Received: April 28, 2006
Dear Mr. Sells:
We have reviewed your Scction 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
2
Page 2 - Mr. Jason Sells
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. 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 Office of Compliance at (240) 276-0120. 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 Manufacturers, 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, M.S. 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):
Device Name: LEGION Cobalt Chrome Revision Knee System
Indications for Use:
Revision Knee System components are indicated for:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The constrained knee systems are designed for use in patients in primary and বা revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
The Revision Knee components are for single use only and are intended for implantation with bone cement.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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 General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K060742
Indications.doc