(226 days)
Not Found
No
The device description focuses on the materials and mechanical components of a total knee replacement system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on non-clinical mechanical testing.
Yes
The LinkSymphoKnee System is a knee replacement system used to treat conditions like degenerative arthritis, indicating its role in alleviating symptoms and restoring function, which falls under the definition of a therapeutic device.
No
The LinkSymphoKnee System is a knee replacement system intended for primary and revision total knee replacement, not for diagnosing conditions.
No
The device description clearly outlines various physical components made of materials like CoCrMo, cPE, and TiAl6V4, which are implanted into the patient. This indicates it is a hardware medical device, not software-only.
Based on the provided text, 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 description clearly states that the LinkSymphoKnee System is a total knee replacement system. It consists of implants (femoral components, tibial components, articulating surfaces, augments, patella) made from various materials (CoCrMo, TiAl6V4, cPE, X-LINKed Vit-E PE). These are surgically implanted into the body.
- Intended Use: The intended use is for primary and revision total knee replacement in skeletally mature patients with specific conditions like arthritis and fracture. This is a surgical procedure, not a diagnostic test performed on samples.
The device is a surgical implant used to replace a damaged knee joint, not a tool for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
General:
The LinkSymphoKnee System 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, HSX, HRY, OIY, KRO
Device Description
The LinkSymphoKnee System is available in multiple versions with different applications, characteristics, and materials.
The LinkSymphoKnee Cruciate Retaining (CR) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for crucial retaining applications made from CoCrMo, a cemented tibial component for fixed bearing (FB) applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for crucial retaining and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur).
The LinkSymphoKnee Posterior Stabilized (PS) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur).
Additonally, the tibial components can also be replaced by an All-Poly tibial component made from cPE.
The LinkSymphoKnee Posterior Stabilized Plus (PS+) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized plus and fixed bearing applications that provides more stability than the standard PS. The articulating surface PS+ provides a constraint from 0 to 3 degrees of varus/valgus and from 0 to 3 degrees of internal/external rotation and is made from cPE or X-LINKed Vit-E PE (E-Dur).
The LinkSymphoKnee Condylar Constrained (CCK) Fixed Bearing (FB) consists of a cemented femoral component for condylar constrained applications made from CoCrMo with a cemented modular stem made from CoCrMo or with a cementless modular stem made from TiAl6V4 (Tilastan), a cemented modular tibial component for fixed bearing applications made from CoCrMo with a cemented modular stem (CoCrMo with or without LINK PorEx (TiNbN) modification) or with a cementless modular stem made from TiAl6V4 (Tilastan), and an articulating surface for condylar constrained (CCK) and fixed bearing (FB) applications made from cPE or X-LINKed Vit-E PE (E-Dur).
The femoral components can be used with distal, posterior, and L-shaped femoral augments made from TiAl6V4 (Tilastan).
The modular tibial components can be used with tibial augments made from TiAl6V4 (Tilastan).
The femoral and tibial components are also available in LINK PorEx (TiNbN) coated version.
Additionally a 3-peg patella can be used with the LinkSymphoKnee System. It is made from cPE or X-LINKed Vit-E PE (E-Dur).
The LinkSymphoKnee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364).
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 and -2)
- Particle analysis (ISO 17853 and ASTM F1877)
- Tibial baseplate component fatigue testing (ISO 14879 and ASTM F1800)
- Contact area/stress analysis
- Fretting / Corrosion (ASTM F1875)
- Disassembly / Constraint testing (ASTM F1223)
The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates.
Clinical performance testing was not required to demonstrate the substantial equivalence of this device.
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.
K182872, K072531, K041106, K043440, K953274, K951987
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
Image /page/0/Picture/0 description: The image shows the date May 13, 2021. The text is in a simple, sans-serif font. The date is written out in full, with the month, day, and year clearly visible. The text is black on a white background.
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs LinkBio Corp. 69 King Street Dover, New Jersey 07801
Re: K202924
Trade/Device Name: LinkSymphoKnee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, HSX, HRY, OIY, KRO Dated: April 5, 2021 Received: April 5, 2021
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.
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K202924
Device Name
LinkSymphoKnee System
Indications for Use (Describe) General:
The LinkSymphoKnee System 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration #:3003386935 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Stefanie Fuchs (Regulatory Affairs)
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-Mail: st.fuchs@linkhh.de |
| Date Prepared: | May 12, 2021 |
| Trade Name: | LinkSymphoKnee System |
| Common Name: | Knee Joint Replacement |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis, 21 CFR §888.3560, product code
JWH
Knee joint femorotibial metal/polymer non-constrained cemented
prosthesis, 21 CFR §888.3520, product code HSX
Knee joint femorotibial metal/polymer semi-constrained cemented
prosthesis, 21CFR §888.3530, product code HRY
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis, 21CFR §888.3560, product code
OIY
Knee joint femorotibial metal/polymer constrained cemented
prosthesis, 21 CFR §888.3510, product code KRO |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | Primary Predicate:
Waldemar Link LINK GEMINI SL Total Knee System: K182872
Additional Predicates:
Smith & Nephew Legion Knee System: K072531, K041106, K043440,
K953274, K951987 |
4
Waldemar Link Endo-Model Knee System: K143179 Waldemar Link Endo-Model Knee System with PorEx (TiNbN) coating: K152431
The LinkSymphoKnee System is available in multiple versions with Device Description: different applications, characteristics, and materials.
The LinkSymphoKnee Cruciate Retaining (CR) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for crucial retaining applications made from CoCrMo, a cemented tibial component for fixed bearing (FB) applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for crucial retaining and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur).
The LinkSymphoKnee Posterior Stabilized (PS) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur).
Additonally, the tibial components can also be replaced by an All-Poly tibial component made from cPE.
The LinkSymphoKnee Posterior Stabilized Plus (PS+) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized plus and fixed bearing applications that provides more stability than the standard PS. The articulating surface PS+ provides a constraint from 0 to 3 degrees of varus/valgus and from 0 to 3 degrees of internal/external rotation and is made from cPE or X-LINKed Vit-E PE (E-Dur).
The LinkSymphoKnee Condylar Constrained (CCK) Fixed Bearing (FB) consists of a cemented femoral component for condylar constrained applications made from CoCrMo with a cemented modular stem made from CoCrMo or with a cementless modular stem made from TiAl6V4 (Tilastan), a cemented modular tibial component for fixed bearing applications made from CoCrMo with a cemented modular stem (CoCrMo with or without LINK PorEx (TiNbN) modification) or with a cementless modular stem made from TiAl6V4 (Tilastan), and an articulating surface for condylar constrained (CCK) and fixed bearing (FB) applications made from cPE or X-LINKed Vit-E PE (E-Dur).
5
| The femoral components can be used with distal, posterior, and L-shaped femoral augments made from TiAl6V4 (Tilastan). | |
|---|---|
| The modular tibial components can be used with tibial augments made from TiAl6V4 (Tilastan). | |
| The femoral and tibial components are also available in LINK PorEx (TiNbN) coated version. | |
| Additionally a 3-peg patella can be used with the LinkSymphoKnee System. It is made from cPE or X-LINKed Vit-E PE (E-Dur). | |
| The LinkSymphoKnee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364). | |
| Indications for Use: | General Indications: |
| The LinkSymphoKnee System 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 System is substantially equivalent to the commercially available devices LINK Gemini SL Total Knee System and the Legion Total Knee System (Smith & Nephew) 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 and -2)
- Particle analysis (ISO 17853 and ASTM F1877)
- Tibial baseplate component fatigue testing (ISO 14879 and ASTM F1800)
- Contact area/stress analysis
- Fretting / Corrosion (ASTM F1875)
- Disassembly / Constraint testing (ASTM F1223) |
| | 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 System is substantially equivalent to
the predicate devices identified in this premarket notification. |
6