GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

K173875 · Stelkast, Inc. · JWH · Jan 19, 2018 · Orthopedic

Device Facts

• Record ID: K173875
• Device Name: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
• Applicant: Stelkast, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 19, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GENFlex2 Total Knee System is intended for: • Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. • Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The device is intended for cemented use only.

Device Story

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert; modular component of cemented total knee replacement system. Input: surgical requirement for knee arthroplasty. Transformation: provides articulating surface geometry for increased stability compared to standard CR inserts. Output: physical prosthetic component. Used in clinical orthopedic surgery by surgeons. Benefits: restores joint function; provides increased stability for patients undergoing primary or revision knee replacement.

Clinical Evidence

No clinical data. Bench testing only: A/P constraint testing and contact area analyses performed to compare modified insert to predicate. Limulus Amebocyte Lysate (LAL) testing performed to verify pyrogen limit compliance.

Technological Characteristics

Modular tibial insert component; materials: EXp Vitamin E Polyethylene and Conventional Polyethylene; cemented fixation; semi-constrained design; geometry modified for increased stability.

Indications for Use

Indicated for patients requiring total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative conditions, and for revision of failed previous reconstructions with adequate bone stock and soft tissue integrity. Intended for cemented use only.

Regulatory Classification

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).

Predicate Devices

• GENFlex2 Total Knee System (K162222)
• Proven Total Knee System (K980276)
• Proven Total Knee System (K063211)
• Proven Total Knee System (K122883)

Submission Summary (Full Text)

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January 19, 2018

StelKast, Inc. % Hollace Rhodes Senior Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K173875

Trade/Device Name: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: December 20, 2017 Received: December 21, 2017

Dear Hollace Rhodes:

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. 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 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K173875

Device Name

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

Indications for Use (Describe)

The GENFlex2 Total Knee System is intended for:

· Total knee replacement due to osteoardis, theumatoid arthritis, and/or post-traumatic degenerative problems.

· Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The device is intended for cemented use only.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary

| Manufacturer: | StelKast, Inc.<br>200 Hidden Valley Road<br>McMurray, PA 15317<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. David Stumpo<br>Vice President of Product Development |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1050 K Street NW, Suite 1000<br>Washington, DC 20001<br>Phone: [phone] |
| Date Prepared: | December 20, 2017 |
| Device Trade Name: | GENFlex2 Total Knee System – Ultra-Congruent CR Tibial<br>Insert |
| Device Common<br>Name: | Total Knee Replacement System |
| Classification: | 21 CFR 888.3560<br>Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis<br>Class II |
| Product Codes: | JWH, OIY |
| Indications for Use: | The GENFlex2 Total Knee System is intended for:<br>• Total knee replacement due to osteoarthritis,<br>osteonecrosis, rheumatoid arthritis, and/or post-<br>traumatic degenerative problems.<br>• Revision of failed previous reconstructions where<br>sufficient bone stock and soft tissue integrity are<br>present. |

The device is intended for cemented use only.

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- Device Description: The purpose of this Special 510(k) is to add the Ultra-Congruent CR Tibial Insert to the GENFlex2 Total Knee System. The Ultra-Congruent CR Tibial Insert is a component within a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The articulating geometry of the Ultra-Congruent CR Tibial Insert provides for increased stability relative to the predicate CR insert. The inserts are manufactured from EXp Vitamin E Polyethylene and Conventional Polyethylene.
- The GENFlex2 Ultra-Congruent CR Tibial Insert is Predicate Devices: substantially equivalent to the predicate inserts of the GENFlex2 Total Knee System (K162222), originally cleared as the Proven Total Knee System (K980276, K063211, and K122883) with respect to intended use, materials, design, range of available sizes, method of fixation, and performance characteristics. The information summarized in the Design Control Activities Summary demonstrates that the modified geometry of the Ultra-Congruent CR Tibial Insert meets the pre-determined acceptance criteria for the verification activities.
- A/P constraint testing was performed on the modified Substantial GENFlex2 Ultra-Congruent CR Tibial Inserts and compared Equivalence: to results for the predicate inserts. Contact area analyses were performed on the modified and predicate devices. All results demonstrate that the modified device performs similarly to the predicate device.

Limulus Amebocyte Lysate (LAL) testing was performed on the implants to establish that the device meets pyrogen limit specifications.