(88 days)
Not Found
No
The document describes a traditional knee replacement system made of standard materials and does not mention any AI/ML components or capabilities.
Yes
The device is a knee system indicated for reconstruction of the diseased knee joint, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is a total knee system indicated for the reconstruction of a diseased knee joint, not for diagnosing a condition.
No
The device description clearly states that the device is a "cemented Search Evolution Knee System" with components manufactured from CoCrMo and UHMWPE, indicating it is a physical implant, not software.
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.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis.
- Performance Studies: The performance studies mentioned are biomechanical testing, which is relevant to the function and durability of a surgical implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Search Evolution Total 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. For Posterior Stabilized (PS) components: Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. The Search Evolution Knee is designed to for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
87 JWH
Device Description
The cemented Search Evolution Knee System is available with two femoral designs, the Posterior Stabilizing (PC) and the Ligament, Cruciate (LC) which retains the ligament (PCL) during implantation. Both designs of the femoral components, and interchangeable tibial plateaus (trays) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.
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)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses" were completed. Biomechanical testing results demonstrate the Search Evolution Knee System is substantially equivalent to other knee systems currently on the market.
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.
K962152, K994128, K974556, K994214, K010101
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
K021313
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS In Accordance with SMDA of 1990
Search Evolution Total Knee System
April 1, 2001
| COMPANY: | Aesculap ®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------|
| CONTACT: | Joyce Kilroy
800-258-1946 (phone)
610-791-6882 (fax)
joyce.kilroy@aesculap.com (email) |
| TRADE NAME: | Search Evolution |
| COMMON NAME: | Search Evolution Total Knee System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 87 JWH |
| CLASSIFICATION: | 888.3560 - Prosthesis, Knee, Patellofemortibial Semi-constrained
Cemented, polymer/metal/polymer |
| REVIEW PANEL: | Orthopedics |
INDICATIONS FOR USE
The Search Evolution Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, posttraumatic 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.
For Posterior Stabilized (PS) Components:
Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Search Evolution Knee is designed for use with bone cement.
DEVICE DESCRIPTION
The cemented Search Evolution Knee System is available with two femoral designs, the Posterior Stabilizing (PC) and the Ligament, Cruciate (LC) which retains the ligament (PCL) during implantation. Both designs of the femoral components, and interchangeable tibial plateaus (trays) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.
1
510(K) Premarket Notification
Search Evolution Total Knee System
KO21313
PAGE Z OF Z
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses" were completed. Biomechanical testing results demonstrate the Search Evolution Knee System is substantially equivalent to other knee systems currently on the market.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Search Evolution Total Knee System is substantially equivalent to:
- . Scorpio Posteriorly Stabilized Knee System (K962152)
- Scorpio Total Stabilizer Total Knee System (K994128) .
- . Scorpio Posterior Cruciate Retaining Knee System (K974556)
- Gem Knee System (K994214) .
- Gem Posterior Stabilized Total Knee System (K010101) .
Attachme]
, 1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2002
Ms. Joyce Kilroy Director, Regulatory Affairs and Quality Assurance Aesculap®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K021313
Trade/Device Name: Search Evolution Total 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 23, 2002 Received: April 25, 2002
Dear Ms. Kilroy:
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.
3
Page 2 - Ms. Joyce Kilroy
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT B.
Page 1 of 1
| 510(k) Number: | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
(
, S .
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|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
Search Evolution Total Knee System Device Name:
Indication for Use:
The Search Evolution Total 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.
For Posterior Stabilized (PS) components:
Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Search Evolution Knee is designed to for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K021313
| Prescription Use | ______________________________________________________________________________________________________________________________________________________________________________ | or Over-the-Counter Use | ______________________________________________________________________________________________________________________________________________________________________________ |
|---|---|---|---|
| ------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
(per 21 CFR 801.109)