(17 days)
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
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.
The provided text is a 510(k) premarket notification for the SPAR-K Instruments, which are accessory instruments for the LINK GEMINI SL Total Knee System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with novel AI/ML device approvals.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone performance (i.e., algorithm only without human-in-the-loop performance).
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the submission focuses on comparing the design and features of the SPAR-K Instruments to their predicate device (LINK GEMINI SL Total Knee System Gemini SL Instruments, 510(k) #K182872).
Key information from the document related to substantial equivalence:
- Device Description: The SPAR-K instruments are a line extension to the instrument system cleared in 510(k) #K182872. They are manual orthopedic surgical reusable instruments designed to aid the implantation of the Gemini SL Total Knee System.
- Modifications: The SPAR-K Instruments incorporate design changes for simplicity of use. These modifications "do not significantly alter the surgical workflow or technique." They accommodate both tibia-first or femur-first workflows. The specific accessory instruments subject to this 510(k) are the femoral, tibial, and patellar resection guides.
- Technological Characteristics and Substantial Equivalence Justification: The modified instruments have the "same intended use, operating principle, basic device designs and purposes, and materials as the unmodified instruments." The modified cutting guides "create the same bone cuts, but feature minor design changes for simplicity and ease of use."
- Study Data: "Non-clinical and clinical performance testing were not required to demonstrate substantial equivalence."
In summary, the document states that the device meets the acceptance criteria for substantial equivalence because its design changes are minor, do not alter the intended use or fundamental technology, and non-clinical/clinical testing was deemed unnecessary for this demonstration.
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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.
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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 (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. KGBarkhausenweg 10D-22339 Hamburg, GermanyPhone: +49-40-539950Facility Registration:3003386935 (Oststraße 4-10)Facility Registration: 3007118403 (Harckesheyde 95) |
|---|---|
| ContactPerson: | Terry Sheridan PowellRegulatory Affairs Program DirectorLinkBio Corp.69 King StreetDover, NJ 07801973-625-1333 x112 |
| DatePrepared: | June 27, 2019 |
| ProprietaryName: | SPAR-K Instruments (for LINK GEMINI SL Total Knee System) |
| CommonName: | Total Knee Prosthesis (Accessory Instruments) |
| ClassificationName: | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,Polymer/Metal/Polymer (888.3560, JWH, Class II) |
| PredicateDevice(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 in510(k) #K182872 with the Gemini SL Total Knee System. The SPAR-Kinstruments are manual orthopedic surgical reusable instruments offered to aid theimplantation of the Gemini SL Total Knee System (K182872). The SPAR-KInstruments incorporate design changes for simplicity of use. The modifications donot significantly alter the surgical workflow or technique. Both the original andmodified (SPAR-K) instruments accommodate tibia first or femur first workflowsaccording to surgeon preference. The modifications do not change the intendeduse, or involve any change in technology. The Class II accessory instrumentswithin the SPAR-K Instrument system that are the subjects of this 510(k) are thefemoral, tibial, and patellar resection guides. |
Intended
The LINK GEMINI SL Total Knee System is indicated for patients suffering from Use: disability due to:
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- 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.
§ 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.