(173 days)
Not Found
No
The summary describes a mechanical knee implant system and its materials, with performance studies focused on mechanical properties and wear. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an artificial knee joint system, explicitly indicated for the reconstruction of diseased knee joints. Its function is to replace or restore a damaged biological structure, thus providing a therapeutic effect by alleviating pain, correcting deformity, and restoring function.
No
Explanation: The device is described as a knee implant system intended for the reconstruction of diseased knee joints, functioning as a prosthetic replacement rather than a tool for diagnosis.
No
The device description clearly outlines physical components made of materials like CoCrMo, UHMWPE, and PEEK Optima®, indicating it is a hardware medical device (a knee prosthesis). The performance studies also focus on the mechanical properties and endurance of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for reconstructing a diseased knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a knee prosthesis, which is consistent with a surgical implant.
- Performance Studies: The performance studies listed are related to the mechanical properties and endurance of the implant, not diagnostic accuracy or performance.
- 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.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The EnduRo Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The EnduRo Knee System is intended for cemented use only.
Product codes
KRO
Device Description
The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial plateau and extension stems are manufactured from CoCrMo. The tibial "gliding surfaces" and patella are manufactured from UHMWPE. The tibial mask is made from PEEK Optima® (LT1). The axial sleeve and femoral bushing components are produced from PEEK Optima® (LT1CA30). The system is made up of numerous components available in various sizes. The femoral, tibial plateau, and extension stems are also available with a ZrN (zirconium nitrate) coating. All components are sterile and for single use only.
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
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)
The following tests were performed to support substantial equivalence:
- Range of Motion of the EnduRo Knee System .
- Wear testing of the EnduRo Knee System .
- Femoral Endurance Properties of the EnduRo Knee System .
- Endurance Properties of the Modular Femoral Stem Assembly of the EnduRo Knee . System
- Tibial Tray Endurance Properties of the EnduRo Knee System .
- Endurance Properties of the rotating axis component in A/P direction of the EnduRo Knee . System
- Endurance Properties of the Modular Tibial Stem Assembly of the EnduRo Knee System .
- . Varus-Valgus Endurance Properties of the EnduRo Knee System
- TibioFemoral Contact Area/Stress at Different Angles of Flexion for the EnduRo Knee . System
- PatelloFemoral Lateral Subluxation Resistance of the EnduRo Knee System .
- PatelloFemoral Contact Area/Stress at Different Angles of Flexion for the EnduRo Knee .
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
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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KIO18K
Page 1 of 2
| B. | 510(k) SUMMARY (as required by 21 CFR 807.92) | |
|---|---|---|
| EnduRo Knee System | ||
| October 27, 2010 | DEC 20 2010 | |
| COMPANY: | Aesculap Implant Systems, LLC | |
| 3773 Corporate Parkway | ||
| Center Valley, PA 18034 | ||
| Establishment Registration Number: 3005673311 | ||
| CONTACT: | Kathy A. Racosky | |
| 610-984-9291 (phone) | ||
| 610-791-6882 (fax) | ||
| Kathy.racosky@aesculap.com | ||
| TRADE NAME: | EnduRo Knee System | |
| COMMON NAME: | Total Knee System | |
| CLASSIFICATION NAME: | Prosthesis, Knee, Femorotibial, Constrained, Cemented | |
| Metal/Polymer | ||
| REGULATION NUMBER: | 888.3510 | |
| PRODUCT CODE: | KRO |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the EnduRo Knee System is substantially equivalent to:
- NexGen Complete Knee Solution Rotating Hinge Knee, Zimmer, Inc. (K013385) .
- Aesculap Implant Systems Columbus REVISION Knee System (K083772) .
DEVICE DESCRIPTION
The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial plateau and extension stems are manufactured from CoCrMo. The tibial "gliding surfaces" and patella are manufactured from UHMWPE. The tibial mask is made from PEEK Optima® (LT1). The axial sleeve and femoral bushing components are produced from PEEK Optima® (LT1CA30). The system is made up of numerous components available in various sizes. The femoral, tibial plateau, and extension stems are also available with a ZrN (zirconium nitrate) coating. All components are sterile and for single use only.
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the Aesculap Implant Systems EnduRo Knee System.
1
K10 1815
Page 2 of 2
INDICATIONS FOR USE
The EnduRo Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The EnduRo Knee System is intended for cemented use only.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the Aesculap Implant Systems EnduRo Knee System are offered in a similar range of shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
The following tests were performed to support substantial equivalence:
- Range of Motion of the EnduRo Knee System .
- Wear testing of the EnduRo Knee System .
- Femoral Endurance Properties of the EnduRo Knee System .
- Endurance Properties of the Modular Femoral Stem Assembly of the EnduRo Knee . System
- Tibial Tray Endurance Properties of the EnduRo Knee System .
- Endurance Properties of the rotating axis component in A/P direction of the EnduRo Knee . System
- Endurance Properties of the Modular Tibial Stem Assembly of the EnduRo Knee System .
- . Varus-Valgus Endurance Properties of the EnduRo Knee System
- TibioFemoral Contact Area/Stress at Different Angles of Flexion for the EnduRo Knee . System
- PatelloFemoral Lateral Subluxation Resistance of the EnduRo Knee System .
- PatelloFemoral Contact Area/Stress at Different Angles of Flexion for the EnduRo Knee .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems LLC % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
DEC 2 0 2010
Re: K101815
Trade/Device Name: EnduRo Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II
Product Code: KRO Dated: October 27, 2010 Received: October 28, 2010
Dear Ms. Racosky:
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 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
3
Page 2 - Ms. Kathy A. Racosky
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 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,
Fch
Mark N. Melkerson
Dec 02
2/22/2
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K101815 |
|---|---|
| ---------------- | --------- |
DEC 2 0 2010
Device Name: EnduRo Knee System
Indications for Use:
The EnduRo Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The EnduRo Knee System is intended for cemented use only.
Prescription Use X (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
for W. Adellerson
(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101815