(28 days)
No
The document describes a mechanical knee implant and its materials. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is a total knee replacement intended for patients with conditions like degenerative arthritis and fracture, which are therapeutic in nature.
No
The device is a knee replacement implant, not a diagnostic tool. Its purpose is to treat conditions like arthritis and fracture, not to identify or diagnose them.
No
The device description clearly indicates it is a physical implant (Articulating Surface) made of materials like cPE and E-Dur, intended for surgical implantation in the knee. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "primary and revision total knee replacement." This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details components of a knee implant (articulating surface, materials like cPE and E-Dur). This is consistent with a medical device for implantation, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition based on in vitro analysis.
Therefore, the LinkSymphoKnee is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
General Indications: The LinkSymphoKnee is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions. This device is intended for cemented use only unless a cementless modular stem is indicated for use.
Indications: Primary degenerative arthritis / osteoarthritis Secondary arthritis resulting from rheumatoid arthritis Fracture
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is available in cPE and E-Dur. In cases of good joint stability, where the ligaments and capsule are intact the FB UC version is available. This configuration is provided for PCL retaining joint reconstruction or if the posterior cruciate ligament is sacrificed. The Fixed Bearing Ultracongruent (FB UC) Articulating Surface is compatible with the already cleared LinkSymphoKnee (K202924). The LinkSymphoKnee is available in multiple versions with different applications, characteristics, and materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature 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)
Non-clinical performance testing and analysis were provided, including: Range of Motion analysis Wear analysis (ISO 14243-1) Particle analysis (ISO 17853 and ASTM F1877) Constraint analysis (ASTM F1223-20) Contact area/stress analysis
The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2023
Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs LinkBio Corp. 69 King Street Dover, New Jersey 07801
Re: K230471
Trade/Device Name: LinkSymphoKnee - Fixed Bearing Ultracongruent (FB UC) Articulating Surface Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 21, 2023 Received: February 21, 2023
Dear Terry Powell:
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.
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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 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 -S
Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
LinkSymphoKnee - Fixed Bearing Ultracongruent (FB UC) Articulating Surface
Indications for Use (Describe)
General Indications:
The LinkSymphoKnee is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions.
This device is intended for cemented use only unless a cementless modular stem is indicated for use.
Indications:
-
Primary degenerative arthritis / osteoarthritis
-
Secondary arthritis resulting from rheumatoid arthritis
-
Fracture
Type of Use (Select one or both, as applicable)
rescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration #: 3004371426 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Pia Müller (Regulatory Affairs)
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53995-841
Fax: +49-40 53995-174
E-Mail: p.mueller@link-ortho.com |
| Date Prepared: | February 24th, 2023 |
| Trade Name: | LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC)
Articulating Surface |
| Common Name: | Knee Joint Replacement |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis, 21 CFR §888.3560, product code
JWH |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | Primary Predicate:
Waldemar Link LinkSymphoKnee: K202924 |
| | Reference Device:
Zimmer Biomet Persona UC Plateaus: K193223 |
| Device Description: | The LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC)
Articulating Surface is available in cPE and E-Dur. In cases of good
joint stability, where the ligaments and capsule are intact the FB UC
version is available. This configuration is provided for PCL retaining
joint reconstruction or if the posterior cruciate ligament is sacrificed.
The Fixed Bearing Ultracongruent (FB UC) Articulating Surface is
compatible with the already cleared LinkSymphoKnee (K202924). The
LinkSymphoKnee is available in multiple versions with different
applications, characteristics, and materials. |
| Indications for Use: | General Indications:
The LinkSymphoKnee is intended for primary and revision total knee
replacement in skeletally mature patients with the following conditions.
This device is intended for cemented use only unless a cementless
modular stem is indicated for use. |
| | Indications: |
| | Primary degenerative arthritis / osteoarthritis Secondary arthritis resulting from rheumatoid arthritis Fracture |
| | Comparison to the predicate: The LinkSymphoKnee is substantially equivalent to the commercially
available devices Persona Personalized Knee System [Zimmer Biomet]
and the LinkSymphoKnee (Waldemar Link) in that all have similar
indications, design, materials and mechanicals safety. All devices are
intended for cemented use only. |
| Performance Testing: | Non-clinical performance testing and analysis were provided,
including:
Range of Motion analysis Wear analysis (ISO 14243-1) Particle analysis (ISO 17853 and ASTM F1877) Constraint analysis (ASTM F1223-20) Contact area/stress analysis |
| | The results of non-clinical performance testing demonstrate that the
device is suitable for its intended purpose and substantially equivalent
to the predicates. |
| Clinical Testing: | Clinical performance testing was not required to demonstrate the
substantial equivalence of this device. |
| Conclusion: | The subject LinkSymphoKnee is substantially equivalent to the
predicate devices identified in this premarket notification. |
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