(164 days)
No
The document describes a traditional knee implant system and a change in sterilization method, with no mention of AI or ML.
Yes
The device is a Total Knee System intended for total knee arthroplasty to address various forms of arthritis and failed knee replacements, which are therapeutic interventions.
No
The device is a Total Knee System, which is an implant used for arthroplasty, not for diagnosing conditions.
No
The device description explicitly details hardware components made of cobalt chromium alloy, UHMWPE, and titanium, which are physical materials used in the construction of the knee system. The submission also focuses on an additional sterilization method for a flexible bag system, further indicating a physical device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a Symmetric(TM) Total Knee System, which is a system of implants (femoral components, tibial inserts, patellar components, etc.) intended for total knee arthroplasty (surgical replacement of the knee joint).
- Intended Use: The intended use clearly states it's for surgical procedures to replace the knee joint due to various conditions like arthritis and failed previous surgeries.
The device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Symmetric(TM) Total Knee System consists of single use components intended for total knee arthroplasty with the following indications:
-
- Rheumatoid arthritis,
-
- Post-traumatic arthritis,
-
- Osteoarthritis,
- Degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. న్.
All components are for cemented use only.
Product codes
JWH
Device Description
The Femoral components are cobalt chromium alloy (ASTM F75). Tibial articular inserts and patellar components are UHMWPE (ASTM F648). Tibial trays, metaphyseal and revision stems, femoral and tibial wedges and cones, and screws (K961157), are titanium (ASTM F1472). Coated cobalt chromium and titanium components feature a coating of plasma sprayed titanium (ASTM F1580).
The purpose of this 510(k) is to submit an additional sterilization method of a flexible bag system. Other descriptive details remain unchanged from the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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
The full sterilization qualification of the flexible bag sterilization vendor is included in the submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 10, 2021
Signal Medical Corporation Dora Culton Ouality Assurance and Regulator Engineer 400 Pvramid Dr. Marysville, Michigan 48040
Re: K203779
Trade/Device Name: Symmetric TM Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: June 4, 2021 Received: June 7, 2021
Dear Dora Culton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203779
Device Name Symmetric(TM) Total Knee System
Indications for Use (Describe)
The Symmetric(TM) Total Knee System consists of single use components intended for total knee arthroplasty with the following indications:
-
- Rheumatoid arthritis,
-
- Post-traumatic arthritis,
-
- Osteoarthritis,
- Degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. న్.
All components are for cemented use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K203779 Page 1 of 2
Image /page/3/Picture/1 description: The image contains a logo with a blue square containing a white wave-like design on the left. To the right of the logo, the words "SIGNAL MEDICAL" are written in blue. Below the logo and text, the words "05 - 510(k) Summary" are written in black.
I. SUBMITTER
Signal Medical Corporation 400 Pyramid Drive Marysville, MI 48040
Ph: (810) 364-7070 Fx: (810) 364-7072
Contact Person: Dora Culton Date Prepared: June 4, 2021
II. DEVICE
| Name of Device: | Symmetric™ Total Knee System |
|---|---|
| Common or Usual Name: | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, |
| Cemented, Polymer/Metal/Polymer | |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis | |
| Regulatory Class: | II |
| Product Codes: | JWH |
| Regulation Number: | 888.3560 |
III. PREDICATE DEVICE
Symmetric Total Knee System, K080199 This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Femoral components are cobalt chromium alloy (ASTM F75). Tibial articular inserts and patellar components are UHMWPE (ASTM F648). Tibial trays, metaphyseal and revision stems, femoral and tibial wedges and cones, and screws (K961157), are titanium (ASTM F1472). Coated cobalt chromium and titanium components feature a coating of plasma sprayed titanium (ASTM F1580).
The purpose of this 510(k) is to submit an additional sterilization method of a flexible bag system. Other descriptive details remain unchanged from the predicate.
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K203779 Page 2 of 2
Image /page/4/Picture/1 description: The image contains the logo for Signal Medical, which includes a blue square with a stylized "S" inside. To the right of the logo, the words "SIGNAL MEDICAL" are written in blue. Below the logo and text, the words "05 - 510(k) Summary" are written in black.
V. INTENDED USE / INDICATIONS FOR USE
The Symmetric™ Total Knee System consists of single use components intended for total knee arthroplasty with the following indications:
-
- Rheumatoid arthritis,
-
- Post-traumatic arthritis,
-
- Osteoarthritis,
-
- Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result,
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
All components are for cemented use only.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The same technological characteristics exist for both devices.
VII. PERFORMANCE DATA
The full sterilization qualification of the flexible bag sterilization vendor is included in the submission.
VIII. CONCLUSIONS
The technological characteristics/features and performance characteristics for the Symmetric Total Knee System are substantially equivalent to the legally marketed predicate device. This 510(k) is submitted for the addition of the flexible bag chamber sterilization method.