Gamma4 System

K222309 · Stryker GmbH · HSB · Nov 15, 2022 · Orthopedic

Device Facts

• Record ID: K222309
• Device Name: Gamma4 System
• Applicant: Stryker GmbH
• Product Code: HSB · Orthopedic
• Decision Date: Nov 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gamma4 System is intended to achieve functionally stable osteosyntheses and stabilization of bones and bone fragments.

Device Story

The Gamma4 System is a hip fracture nailing system consisting of sterile implants (trochanteric/long nails, lag screws, end caps) and non-sterile targeting instruments. The system is used by surgeons in clinical settings to treat femoral fractures. The subject of this submission is the addition of the 'Plus Targeting Arm' and 'Plus Nail Holding Screw' to the existing system. These instruments facilitate the accurate placement of implants during surgery. The Plus Targeting Arm features a rounded design with increased extension from the nail axis compared to the previously cleared Proximal Targeting Arm, providing improved tissue clearance. The system utilizes mechanical targeting to guide the insertion of intramedullary nails and screws. The device provides structural stabilization of bone fractures, aiding in patient recovery.

Clinical Evidence

No clinical data was required for this submission; substantial equivalence was supported by non-clinical performance assessment, specifically targeting accuracy testing.

Technological Characteristics

Implants: Titanium alloy (Ti6Al4V ELI) per ASTM F136. Targeting instruments: Stainless steel (AISI 431), carbon fiber reinforced PEEK, and unreinforced PEEK. System is a mechanical intramedullary fixation rod and targeting assembly. No software or electronic components.

Indications for Use

Indicated for treatment of stable and unstable fractures, stabilization of bones, and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric, and shaft regions of the femur, including osteoporotic and osteopenic bone.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Gamma4 System (K213328)
• Gamma3 System (K213328)

Submission Summary (Full Text)

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November 15, 2022

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Stryker GMBH Cindy Leon Staff Specialist, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430

Re: K222309

Trade/Device Name: Gamma4 System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 31, 2022 Received: October 31, 2022

Dear Cindy Leon:

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 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) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2022.11.15
14-05'00'

For Victoria Lilling, M.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

510(k) Number (if known)

K222309

Device Name Gamma4 System

Indications for Use (Describe)

The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| 510(k) Summary | |
|---------------------------|-----------------------------------------------------|
| I. SUBMITTER | |
| Sponsor: | Stryker GmbH |
| | Bohnackerweg 1 |
| | 2545 Selzach / Switzerland |
| Contact Person: | Cindy Leon |
| | Staff Specialist, Regulatory Affairs |
| | 325 Corporate Drive |
| | Mahwah, NJ 07430 |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Prepared: | August 01, 2022 |
| II. DEVICE | |
| Name of Device: | Gamma4 System |
| Common Name: | Gamma4 System |
| | Rod, fixation, intramedullary and accessories |
| Regulation Number / Name: | Gamma4 System |
| | 21CFR 888.3020 (Intramedullary fixation rod) |
| Product Code: | Gamma4 System |
| | HSB (Rod, fixation, intramedullary and accessories) |
| Regulatory Class: | Class II |
| Primary Predicate: | Gamma4 System (K213328) |
| Additional Predicates: | Gamma3 System (K213328) |

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Traditional 510(k) Premarket Notification

#### III. PREDICATE DEVICE

## IV. DEVICE DESCRIPTION

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market two (2) new accessory devices into the Gamma4 System: Plus Targeting Arm and Plus Nail Holding Screw.

The Gamma4 System was previously cleared under K213328, is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The nails, lag screws and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.

The Gamma4 System has two (2) types of targeting devices: (1) Proximal Targeting Arm (consisting of Targeting Sleeve and Nail Holding Screw) previously cleared in K213328 and (2) the subject devices, Plus Targeting Arm (consisting of the Plus Nail holding Screw and Targeting Sleeve, previously cleared in K213328). The previously cleared Proximal Targeting Arm has less of an extension out from the axis of the nail, whereas the subject device is more rounded and extends out further to ensure sufficient tissue clearance. Both targeting devices are manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.

## V. INTENDED USE

#### Gamma4 System

The introduction of the Plus Targeting Arm and Plus Nail Holding Screw does not alter the intended use of the subject system previously cleared in K213328. The intended use is provided below:

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The Gamma4 System is intended to achieve functionally stable osteosyntheses and stabilization of bones and bone fragments.

## VI. INDICATION FOR USE

#### Gamma4 System

The introduction of the Plus Targeting Arm and Plus Nail Holding Screw does not alter the indication for use of the subject system previously cleared in K213328. The indication for use is provided below:

The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

#### Summary of Technologies

A comparison of the systems demonstrated that the subject Gamma4 System is substantially equivalent to the following predicates in regards to intended use, material, design, and operational principles:

- Gamma4 System (K213328)
- Gamma3 System (K213328)

## Non-Clinical Testing

The following performance assessment was made in support of substantial equivalence:

- . Targeting accuracy testing
# CLINICAL TESTING

Clinical testing was not required for this submission.

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# CONCLUSION

The subject Gamma4 System is substantially equivalent to the previously cleared Gamma4 System (K213328) primary predicate and the Gamma3 System (K213328) additional predicate device.