Gamma4 System

K230512 · Stryker GmbH · HSB · Jun 9, 2023 · Orthopedic

Device Facts

• Record ID: K230512
• Device Name: Gamma4 System
• Applicant: Stryker GmbH
• Product Code: HSB · Orthopedic
• Decision Date: Jun 9, 2023
• 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

Gamma4 System is a hip fracture nailing system consisting of sterile implants (nails, lag screws, end caps) and non-sterile instruments (targeting devices). Used by orthopedic surgeons in clinical settings to achieve stable osteosynthesis. Implants are inserted into the femur to stabilize fractures or correct deformities. System includes intermediate nails, RC lag screws, and targeting sleeves. Device provides mechanical stabilization of bone fragments to facilitate healing. No software or AI components.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including targeting accuracy, bending fatigue strength (ASTM F1264), construct fatigue strength, cut-out testing, torsional stiffness (ASTM F1264), and MR evaluation.

Technological Characteristics

Implants: Titanium alloy (Ti6Al4V ELI) per ASTM F136. Instruments: Stainless steel (AISI 431), carbon fiber reinforced PEEK, and unreinforced PEEK. System includes intramedullary nails, lag screws, end caps, and targeting devices. Mechanical fixation principle. 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 intracapsular, trochanteric, subtrochanteric, and shaft regions of the femur (including osteoporotic and osteopenic bone). RC Lag Screw is also indicated for rotationally unstable fractures.

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

• Gamma3 System (K213328)
• T2 Alpha Femur Antegrade GT/PF Nailing System (K203819)

Submission Summary (Full Text)

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June 9, 2023

Stryker GmbH Cindy Leon Sr. Staff Specialist, Regulatory 325 Corporate Drive Mahwah, New Jersey 07430

Re: K230512

Trade/Device Name: Gamma4 System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 25, 2023 Received: May 25, 2023

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

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

| Sincerely, | |
|------------|-------------------------------------------|
| Farzana | Digitally signed by<br>Farzana Sharmin -S |
| Sharmin -S | Date: 2023.06.09<br>16:04:36 -04'00' |

Farzana Sharmin, Ph.D. Acting 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)

K230512

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). The RC Lag Screw is also indicated for rotationally unstable fractures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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| Section 9: 510(k) Summary | |
|---------------------------|-----------------------------------------------------|
| I. SUBMITTER | |
| Sponsor: | Stryker GmbH |
| | Bohnackerweg 1 |
| | 2545 Selzach / Switzerland |
| Contact Person: | Cindy Leon |
| | Sr. Staff Specialist, Regulatory Affairs |
| | 325 Corporate Drive |
| | Mahwah, NJ 07430 |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Prepared: | February 24, 2023 |
| 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 |

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Traditional 510(k) Premarket Notification

### III, PREDICATE DEVICE

Primary Predicate: Gamma3 System (K213328)

Additional Predicates:

T2 Alpha Femur Antegrade GT/PF Nailing System (K203819)

## IV. DEVICE DESCRIPTION

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market new devices into the Gamma4 System, add new indications for use for the RC Lag Screws and update the current surgical technique to include an optional section to use bone void fillers.

The Gamma4 System was previously cleared in K222309, 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 subject devices (Intermediate Nails and RC Lag Screw) are also sterile implants in various diameters and sizes as well as a non-sterile Intermediate Targeting Sleeve. All nails and screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136 and the targeting device is manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.

#### V. INTENDED USE

#### Gamma4 System

The introduction of the Intermediate Nails, RC Lag Screw and Intermediate Targeting Sleeve does not alter the intended use of the subject system previously cleared in K222309. The intended use is provided below:

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

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## VI. INDICATIONS FOR USE

#### Gamma4 System

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).

The RC Lag Screw is also indicated for rotationally unstable fractures.

#### 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:

- Gamma3 System (K213328) .
- . T2 Alpha Femur Antegrade GT/PF Nailing System (K203819)

#### Non-Clinical Testing

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

The following tests were performed:

- . Targeting accuracy testing
- Bending Fatigue Strength per ASTM F1264 .

The following performance assessment was conducted:

- Construct Fatigue Strength Testing ●
- . Cut-out testing
- . Torsional Stiffness per ASTM F1264
- MR evaluation ●

Testing demonstrated that the Gamma4 System is equivalent in mechanical performance to the Gamma3 System primary predicate device (K213328) and T2 Alpha Femur Antegrade GT/PF Nailing System (K203819) additional predicate device.

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# CLINICAL TESTING

Clinical testing was not required for this submission.

## CONCLUSION

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