GraftGun Universal Graft Delivery System (GDS®)
Device Facts
| Record ID | K262581 |
|---|---|
| Device Name | GraftGun Universal Graft Delivery System (GDS®) |
| Applicant | SurGenTec, LLC |
| Product Code | FMF · General Hospital |
| Decision Date | Aug 26, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.
Device Story
GraftGun Universal Graft Delivery System (GDS®) is a sterile, single-use, disposable device used for delivering bone graft materials (allograft, autograft, or synthetic) to orthopedic surgical sites. System components include a dispensing unit, loading device, graft tubes, and adapter tips. Operated by surgeons in clinical settings; device facilitates graft placement via direct visualization or minimally invasive access. Device functions as a manual piston-style delivery mechanism. Benefits include controlled, efficient graft material application to surgical sites.
Clinical Evidence
Bench testing only. Assessments included sterilization validation per ISO 11137 and packaging validation per ISO 11607-1/2, ASTM F1886, ASTM F2096, and ASTM F88.
Technological Characteristics
Piston syringe mechanism; sterile, single-use disposable components with reusable adapter tips. Materials and design identical to predicates. Sterilization per ISO 11137. Packaging per ISO 11607-1/2, ASTM F1886, ASTM F2096, ASTM F88.
Indications for Use
Indicated for adults requiring delivery of hydrated allograft, autograft, or synthetic bone graft material to orthopedic surgical sites via direct visualization or minimally invasive techniques.
Regulatory Classification
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Predicate Devices
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
August 26, 2026
SurGenTec, LLC
Gui Pires
VP of Operations
911 Clint Moore Rd.
Boca Raton, Florida 33487
Re: K262581
Trade/Device Name: GraftGun Universal Graft Delivery System (GDS®)
Regulation Number: 21 CFR 880.5860
Regulation Name: Piston Syringe
Regulatory Class: Class II
Product Code: FMF
Dated: July 25, 2026
Received: July 27, 2026
Dear Gui Pires:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262581 - Gui Pires
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K262581 - Gui Pires
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Sincerely,
Jesse Muir, Ph.D.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma 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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262581 | ? |
| Please provide the device trade name(s). | | ? |
| GraftGun Universal Graft Delivery System (GDS®) | | |
| Please provide your Indications for Use below. | | ? |
| The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive. | | |
| Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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# 510(k) Summary
K262581
Page 1 of 1
Submitter: SurGenTec, LLC
911 Clint Moore Rd
Boca Raton, FL 33487
Official Correspondent: Gui Pires
VP of Operations
SurGenTec, LLC
Date Prepared: August 25, 2026
Trade Name: GraftGun Universal Graft Delivery System (GDS®)
Common Name: Piston / Syringe
Classification: 21 CFR § 880.5860
Product Code: FMF
Predicate Device: GraftGun Universal Delivery System (GDS®) (K170675, K180937 and K243580)
# Device Description:
The GraftGun Universal Graft Delivery System (GDS®) consists of a sterile, single-use, disposable device, and sterile or non-sterile reusable Adapter Tips intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The GraftGun Universal Graft Delivery System (GDS®) includes the GraftGun Dispensing Unit, Loading Device, Graft Tubes, and Adapter Tips.
# Indications for Use:
The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.
# Technological Similarities / Differences:
The subject device incorporates the same design, same material composition, and same principles of operation as the predicate device. The only difference between the subject and predicate device is that the Adapter Tips may be provided sterile.
# Substantial Equivalence:
The subject GraftGun Universal Graft Delivery System (GDS®) is substantially equivalent to the previous cleared versions in K170675, K180937, K243580 with respect to intended use, materials, design, and function.
# Performance Testing of Subject GraftGun Universal Graft Delivery System (GDS®):
The following assessments have been performed on GraftGun Universal Graft Delivery System (GDS®).
- Sterilization Validation per ISO 11137
- Packaging Validation ISO 11607-1 and -2, ASTM F1886, ASTM F2096, ASTM F88
# Conclusion:
The subject GraftGun Universal Graft Delivery System (GDS®) is substantially equivalent to the cited predicate devices.
