(17 days)
No
The document explicitly states that the modifications "do not involve any change in technology" and describes the devices as "manual orthopedic surgical reusable instruments." There is no mention of AI, ML, or any related concepts.
No.
The document describes surgical instruments used to aid the implantation of a total knee system, not the therapeutic device itself.
No
The document describes surgical instruments used for implanting a knee system, not for diagnosing medical conditions.
No
The device description explicitly states that the SPAR-K instruments are "manual orthopedic surgical reusable instruments" and are a "line extension to the instrument system cleared in 510(k) #K182872". This indicates the device is hardware, specifically surgical instruments, 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 describes a surgical implant (Total Knee System) and surgical instruments used to aid in the implantation of that system. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as manual orthopedic surgical reusable instruments. This aligns with surgical tools, not diagnostic devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used during surgery to implant a prosthetic joint.
N/A
Intended Use / Indications for Use
The LINK GEMINI SL Total Knee System is indicated for patients suffering from disability due to:
- · Degenerative, post-traumatic or rheumatoid arthritis;
- · Avascular necrosis of the femoral condyle;
· Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
· Moderate valgus, varus or flexion deformities.
This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented use. Only cementless labeled modular stems are indicated for uncemented use
Product codes
JWH
Device Description
The SPAR-K instruments are a line extension to the instrument system cleared in 510(k) #K182872 with the Gemini SL Total Knee System. The SPAR-K instruments are manual orthopedic surgical reusable instruments offered to aid the implantation of the Gemini SL Total Knee System (K182872). The SPAR-K Instruments incorporate design changes for simplicity of use. The modifications do not significantly alter the surgical workflow or technique. Both the original and modified (SPAR-K) instruments accommodate tibia first or femur first workflows according to surgeon preference. The modifications do not change the intended use, or involve any change in technology. The Class II accessory instruments within the SPAR-K Instrument system that are the subjects of this 510(k) are the femoral, tibial, and patellar resection guides.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical and clinical performance testing were not required to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 18, 2019
Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs Program Director LinkBio Corp. 69 King Street Dover, New Jersey 07801
Re: K191755
Trade/Device Name: SPAR-K Instruments (for use with Gemini SL 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: July 1, 2019 Received: July 1, 2019
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.
1
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 (OS) 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,
For CAPT Raquel Peat, PhD, MPH, USPHS Director 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
510(k) Number (if known) K191755
Device Name
SPAR-K Instruments (for use with Gemini SL Total Knee System)
Indications for Use (Describe)
The LINK GEMINI SL Total Knee System is indicated for patients suffering from disability due to:
- · Degenerative, post-traumatic or rheumatoid arthritis;
- · Avascular necrosis of the femoral condyle;
· Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
· Moderate valgus, varus or flexion deformities.
This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented use. Only cementless labeled modular stems are indicated for uncemented use
| 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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| 510(k)
Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
D-22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration:3003386935 (Oststraße 4-10)
Facility Registration: 3007118403 (Harckesheyde 95) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Terry Sheridan Powell
Regulatory Affairs Program Director
LinkBio Corp.
69 King Street
Dover, NJ 07801
973-625-1333 x112 |
| Date
Prepared: | June 27, 2019 |
| Proprietary
Name: | SPAR-K Instruments (for LINK GEMINI SL Total Knee System) |
| Common
Name: | Total Knee Prosthesis (Accessory Instruments) |
| Classification
Name: | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer/Metal/Polymer (888.3560, JWH, Class II) |
| Predicate
Device(s): | LINK GEMINI SL Total Knee System Gemini SL Instruments (510(k) #K182872) |
| Device | Description: The SPAR-K instruments are a line extension to the instrument system cleared in
510(k) #K182872 with the Gemini SL Total Knee System. The SPAR-K
instruments are manual orthopedic surgical reusable instruments offered to aid the
implantation of the Gemini SL Total Knee System (K182872). The SPAR-K
Instruments incorporate design changes for simplicity of use. The modifications do
not significantly alter the surgical workflow or technique. Both the original and
modified (SPAR-K) instruments accommodate tibia first or femur first workflows
according to surgeon preference. The modifications do not change the intended
use, or involve any change in technology. The Class II accessory instruments
within the SPAR-K Instrument system that are the subjects of this 510(k) are the
femoral, tibial, and patellar resection guides. |
Intended
The LINK GEMINI SL Total Knee System is indicated for patients suffering from Use: disability due to:
4
- Degenerative, post-traumatic or rheumatoid arthritis: .
- Avascular necrosis of the femoral condyle;
- . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
- Moderate valgus, varus or flexion deformities. .
This device may also be indicated in the salvage of previously failed surgical attempts.
The device is intended for cemented use. Only cementless labeled modular stems are indicated for uncemented use.
Technological Characteristics and Substantial Equivalence
The modified Class II accessory instruments within the SPAR-K Instrument system that are the subjects of this 510(k) have the same intended use, operating principle, basic device designs and purposes, and materials as the unmodified instruments. The modified cutting quides create the same bone cuts, but feature minor design changes for simplicity and ease of use. A comparison of designs and features supported the substantial equivalence of the modified to the original instruments. Non-clinical and clinical performance testing were not required to demonstrate substantial equivalence.
Conclusion
The subject SPAR-K Instruments that are the subjects of this 510(k) (Class II accessory instruments) are Substantially Equivalent to the predicate instruments identified in this premarket notification.