(176 days)
Not Found
No
The document describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is a prosthesis intended to replace a severely painful and/or disabled joint damaged by osteoarthritis, traumatic arthritis, or a failed previous implant, which indicates it provides therapy by restoring joint function and alleviating pain.
No
Explanation: The device is a knee prosthesis, which is an implant used to replace a damaged joint, not a tool used to diagnose medical conditions.
No
The device description clearly states it is a prosthesis consisting of physical components (femoral, tibial, and meniscal) made from materials like CoCrMo and UHMWPE. It is a hardware implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The UNIVATION® Unicompartmental Knee System is a prosthesis designed to be surgically implanted to replace a damaged part of the knee joint. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for surgical implantation in patients with knee damage, not for performing diagnostic tests on samples.
Therefore, based on the provided information, the UNIVATION® Unicompartmental Knee System clearly falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
Product codes
HRY
Device Description
The UNIVATION® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The UNIVATION® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (Zirconium nitride) 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 (medial)
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)
Aesculap conducted a risk analysis of the design modifications and as a result of the risk assessment, customized endurance testing based upon ISO 14879-1:2000 and ASTM F1800-07 were used to evaluate bone interface geometry of both modified femur and tibia components for 5 million load cycles and 10 million load cycles, respectively, The results were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
| K131167 | Page 1 of 2 |
|---|---|
| B. | 510(k) SUMMARY (as required by 21 CFR 807.92) |
| UNIVATION® Unicompartmental Knee System | |
| October 08, 2013 | |
| COMPANY: | Aesculap Implant Systems® LLC |
| 3773 Corporate Parkway | |
| Center Valley, PA 18034 | |
| Establishment Registration Number: 3005673311 | |
| CONTACT: | Julie Tom Wing |
| 610-984-9147 (phone) | |
| 610-791-6882 (fax) | |
| TRADE NAME: | UNIVATION® |
| COMMON NAME: | Unicompartmental Knee System |
| CLASSIFICATION NAME: | Prosthesis, Knee, Femorotibial, Semi-constrained, |
| Cemented, Metal/Polymer | |
| REGULATION NUMBER: | 888.3530 |
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | HRY |
| PANEL: | Orthopedic |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems®, LLC. UNIVATION® Unicompartmental Knee System is substantially equivalent to the original UNIVATION® Unicompartmental Knee System cleared in 510(K) K081293. The indications for use are equivalent to the predicate.
DEVICE DESCRIPTION
The UNIVATION® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The UNIVATION® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (Zirconium nitride) coating. All components are sterile and for single use only.
1
K131167
INDICATIONS FOR USE
The indications for use remain unchanged as follows:
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s)}
The entire UNIVATION® Unicompartmental Knee System was cleared under 510(K) K081293. The fundamental scientific technology and materials for UNIVATION® Unicompartmental Knee System remain the same. The indications for use are equivalent to the predicate.
The only differences are a design modification of the femur and tibia at posterior fin and distal teeth.
PERFORMANCE DATA
Aesculap conducted a risk analysis of the design modifications and as a result of the risk assessment, customized endurance testing based upon ISO 14879-1:2000 and ASTM F1800-07 were used to evaluate bone interface geometry of both modified femur and tibia components for 5 million load cycles and 10 million load cycles, respectively, The results were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and flow, resembling a human figure or a symbol of health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
October 17, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Aesculan Implant Systems, LLC Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K131167
Trade/Device Name: UNIVATION* Unicompartmental Knec 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 Dated: September 18, 2013 Received: September 20, 2013
Dear Ms. Tom Wing:
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 accordunce 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 fabeling must be truthful and not misleading.
If your device is classified (see above) into cither 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
3
Page 2 - Ms. Julie Tom Wing
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
UNIVATION Unicompartmental Knee System
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number:_K131167
Device Name: UNIVATION® Unicompartmental Knee System
Indications for Use:
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
X Prescription Use_ ______________
(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)
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