(28 days)
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
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.
This document does not describe an AI/ML device but rather a knee joint prosthetic. Therefore, many of the requested fields and information are not relevant or present in the provided text.
Based on the information provided for the LinkSymphoKnee - Fixed Bearing Ultracongruent (FB UC) Articulating Surface:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (implied from testing) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Range of Motion (comparable to predicate) | Accepted (suitable for intended purpose) |
| Wear (meeting ISO 14243-1 standards) | Accepted (suitable for intended purpose) | |
| Particle analysis (meeting ISO 17853 and ASTM F1877 standards) | Accepted (suitable for intended purpose) | |
| Constraint (meeting ASTM F1223-20 standards) | Accepted (suitable for intended purpose) | |
| Contact area/stress (comparable to predicate) | Accepted (suitable for intended purpose) | |
| Design & Materials | Similar design to predicate devices | Similar to predicate devices |
| Similar materials to predicate devices | Similar to predicate devices | |
| Indications for Use | Similar indications to predicate devices | Similar to predicate devices |
| Safety | Mechanical safety comparable to predicate devices | Comparable to predicate devices |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable/Provided. The performance testing described is for a medical device (knee implant), not an AI/ML system. The testing likely involved mechanical testing of device samples.
- Data provenance: Not explicitly stated, but the testing was non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/ML system requiring expert-established ground truth. Performance was evaluated through non-clinical mechanical testing standards.
4. Adjudication method for the test set:
- Not applicable. Performance was evaluated through non-clinical mechanical testing standards, not expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-driven algorithm.
7. The type of ground truth used:
- For mechanical performance testing, the "ground truth" would be established physical and engineering standards (e.g., ISO 14243-1, ISO 17853, ASTM F1877, ASTM F1223-20) and benchmark data from predicate devices.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML system, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
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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. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration #: 3004371426 |
|---|---|
| Contact Person: | Waldemar Link GmbH & Co. KGPia Müller (Regulatory Affairs)Oststraße 4-10Norderstedt, GERMANY 22844Phone: +49-40 53995-841Fax: +49-40 53995-174E-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 codeJWH |
| 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 goodjoint stability, where the ligaments and capsule are intact the FB UCversion is available. This configuration is provided for PCL retainingjoint reconstruction or if the posterior cruciate ligament is sacrificed.The Fixed Bearing Ultracongruent (FB UC) Articulating Surface iscompatible with the already cleared LinkSymphoKnee (K202924). TheLinkSymphoKnee is available in multiple versions with differentapplications, characteristics, and materials. |
| Indications for Use: | General Indications:The LinkSymphoKnee is intended for primary and revision total kneereplacement in skeletally mature patients with the following conditions.This device is intended for cemented use only unless a cementlessmodular 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 commerciallyavailable devices Persona Personalized Knee System [Zimmer Biomet]and the LinkSymphoKnee (Waldemar Link) in that all have similarindications, design, materials and mechanicals safety. All devices areintended 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 thedevice is suitable for its intended purpose and substantially equivalentto the predicates. | |
| Clinical Testing: | Clinical performance testing was not required to demonstrate thesubstantial equivalence of this device. |
| Conclusion: | The subject LinkSymphoKnee is substantially equivalent to thepredicate devices identified in this premarket notification. |
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§ 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.