AEON™ Endoscopic Powered Stapler

K251482 · Lexington Medical, Inc. · GAG · Jul 11, 2025 · General Hospital

Device Facts

Record IDK251482
Device NameAEON™ Endoscopic Powered Stapler
ApplicantLexington Medical, Inc.
Product CodeGAG · General Hospital
Decision DateJul 11, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4740
Device ClassClass 2
AttributesTherapeutic, Pediatric

Intended Use

The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

Device Story

AEON Endoscopic Powered Stapler system consists of AC-powered handle and single-use reloadable cartridges; places two triple-staggered rows of titanium staples while simultaneously transecting tissue between rows. Used in OR by surgeons for resection, transection, and anastomosis creation in general, abdominal, gynecologic, pediatric, and thoracic surgeries. Handle available in 60mm, 160mm, and 260mm lengths; reloads accommodate varying tissue thicknesses. Software controls stapler operation. Device provides mechanical stapling and cutting; surgeon observes tissue and device status to guide clinical decision-making. Benefits include consistent staple formation and tissue transection during endoscopic procedures.

Clinical Evidence

Real-world evidence provided to support safety and effectiveness for thoracic applications. No new bench or animal testing required as device is identical to reference device (K234039).

Technological Characteristics

Powered surgical stapler; titanium staples; linear knife cutting mechanism. Available in 60/160/260mm handle lengths. EO sterilized; single-use. AC powered. Software-controlled operation. Identical to reference device (K234039) in design, materials, and electrical/EMC requirements.

Indications for Use

Indicated for patients undergoing general, abdominal, gynecologic, pediatric, or thoracic surgery requiring resection, transection, or creation of anastomoses, including procedures involving liver, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.

Regulatory Classification

Identification

Surgical stapler for external use: A specialized prescription device used to deliver compatible staples to skin during surgery. Surgical stapler for internal use: A specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following: (A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type; (B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force; (C) Measurement of staple line strength; (D) Confirmation of staple line integrity; and (E) In vivo confirmation of staple line hemostasis. (ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device. (iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed. (iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use. (v) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (vi) Performance data must demonstrate the sterility of the device. (vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling. (viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life. (ix) Labeling of the device must include the following: (A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity. (B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including: ( *1* ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;( *2* ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;( *3* ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;( *4* ) Avoidance of use of the stapler on the aorta;( *5* ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;( *6* ) Ensuring stapler compatibility with staples; and( *7* ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling. (D) List of staples with which the stapler has been demonstrated to be compatible. (E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device. (F) Information regarding tissues on which the stapler is intended to be used. (G) Identification of safety mechanisms of the stapler. (H) Validated methods and instructions for reprocessing of any reusable device components. (I) An expiration date/shelf life. (x) Package labels must include critical information and technical characteristics necessary for proper device selection.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 11, 2025 Lexington Medical, Inc. Sharon Timberlake Head of Global Regulatory Affairs & Quality 23 Crosby Drive Bedford, Massachusetts 01730 Re: K251482 Trade/Device Name: AEON™ Endoscopic Powered Stapler Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical Stapler Regulatory Class: Class II Product Code: GAG, GDW Dated: May 9, 2025 Received: May 14, 2025 Dear Sharon Timberlake: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251482 - Sharon Timberlake Page 2 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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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- {2} K251482 - Sharon Timberlake Page 3 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). Sincerely, TEK N. LAMICHHANE -S Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251482 | | | Device Name | | | AEON™ Endoscopic Powered Stapler | | | Indications for Use (Describe) | | | The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen. | | | 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) | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} Traditional 510(k) Premarket Notification AEON™ Endoscopic Powered Stapler This 510(k) Summary is prepared in accordance with the requirements of 21 CFR 807.92 1. Date Prepared July 11, 2025 2. Submitter & 510(k) Owner Information Submitter: Lexington Medical, Inc. 23 Crosby Drive Bedford, Massachusetts 01730 Official Correspondent: Sharon L. Timberlake, MSHS, RAC, CCRA Head of Global Regulatory Affairs & Quality Telephone: (617) 957-1434 Email: sharon.timberlake@lexington-med.com 3. Device Information Trade Name: AEON™ Endoscopic Powered Stapler Common Name: Surgical Stapler Classification Name: Implantable Staple, Surgical Stapler Regulation Number: 21 CFR 878.4740, 21 CFR 878.4750 Regulation Class: II Primary Product Code: GAG Secondary Product Code: GDW 4. Predicate & Reference Device Identification Predicate Device Trade Name: AEON™ Endoscopic Stapler 510(k) Number: K222210 Common Name: Surgical Stapler Classification Name: Implantable Staple, Surgical Stapler Regulation Number: 21 CFR 878.4740, 21 CFR 878.4750 Regulation Class: II Primary Product Code: GAG Secondary Product Code: GDW Reference Device Trade Name: AEON™ Endoscopic Powered Stapler 510(k) Number: K234039 Common Name: Surgical Stapler Classification Name: Implantable Staple, Surgical Stapler Regulation Number: 21 CFR 878.4740, 21 CFR 878.4750 Regulation Class: II Primary Product Code: GAG Secondary Product Code: GDW 510(k) Summary K251482 Page 1 of 4 {5} Traditional 510(k) Premarket Notification AEON™ Endoscopic Powered Stapler 5. Device Description The AEON Endoscopic Powered Stapler system is composed of the AEON Endoscopic Powered Stapler Handle ("Powered Handle") and AEON Endoscopic Stapler Reloads ("Reloads"). The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The Powered Handle may be reloaded and fired up to 20 times in a single procedure. The Powered Handle is available in three different lengths (60mm, 160mm and 260mm) and the Reloads are available in multiple staple sizes to accommodate various tissue thicknesses. The AEON Endoscopic Powered Stapler uses software to control the operation of the stapler and is AC powered. The device is sterile packaged and is labeled for single use. 6. Indications for Use The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen. 7. Technological Characteristics Compared to the Predicate Surgical stapling is the technological principle for both the subject and the predicate device. Just like its predicate and reference devices, the AEON Endoscopic Powered Stapler is used in surgical procedures to staple and cut tissue for resection, transection, and creation of anastomoses. The same Reloads are attached to the subject device, predicate device and reference device for use in all surgical applications. There are no changes to the Powered Handle product specifications when compared to its predicate as a result of the expanded Indications for Use. The subject device and predicate device both share the expanded indications to include thoracic applications. | Item | AEON Endoscopic Powered Stapler (Subject Device) | AEON Endoscopic Stapler (Predicate Device) | AEON Endoscopic Powered Stapler (Reference Device) | SE | | --- | --- | --- | --- | --- | | 510(k) Number | Not Assigned | K222210 | K234039 | Yes | | Product Code | GAG, GDW | GAG, GDW | GAG, GDW | Yes | | Regulation Number | 878.4750, 878.4740 | 878.4750, 878.4740 | 878.4750, 878.4740 | Yes | | Classification | II | II | II | Yes | 510(k) Summary K251482 Page 2 of 4 {6} Traditional 510(k) Premarket Notification AEON™ Endoscopic Powered Stapler | Item | AEON Endoscopic Powered Stapler (Subject Device) | AEON Endoscopic Stapler (Predicate Device) | AEON Endoscopic Powered Stapler (Reference Device) | SE | | --- | --- | --- | --- | --- | | Indications for Use/ Intended Use | The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen. | The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen. | The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen. | Yes | | Reload Features | Tissue Stop | Tissue Stop | Tissue Stop | Yes | | | Anvil | Anvil | Anvil | Yes | | | Cut Line | Cut Line | Cut Line | Yes | | | Knife | Knife | Knife | Yes | | | Cartridge | Cartridge | Cartridge | Yes | | Operation Principle | Powered | Manual | Powered | Yes | | Contains Software | Yes | No | Yes | Yes | | Cutting Mechanism | Linear Knife | Linear Knife | Linear Knife | Yes | | Cutting Length (mm) | 26, 41, 56 | 26, 41, 56 | 26, 41, 56 | Yes | | Open Staple Height (mm) | 2.0, 2.5, 3.25, 4.0, 5.0 | 2.0, 2.5, 3.25, 4.0, 5.0 | 2.0, 2.5, 3.25, 4.0, 5.0 | Yes | | Closed Staple Height (mm) | 0.75, 1.0, 1.5, 1.8, 2.2 | 0.75, 1.0, 1.5, 1.8, 2.2 | 0.75, 1.0, 1.5, 1.8, 2.2 | Yes | | Single-Use | Yes | Yes | Yes | Yes | | Sterilization Method | EO Sterilized | EO Sterilized | EO Sterilized | Yes | 510(k) Summary K251482 Page 3 of 4 {7} Traditional 510(k) Premarket Notification AEON™ Endoscopic Powered Stapler ## 8. Performance Data ### Bench and Animal Non-clinical testing (bench and animal) was not required to support the expanded Indications for Use. The subject device is identical to the reference device (K234039) in design, technological characteristics, materials, software, IEC/EMC electrical requirements, packaging and performance characteristics. Therefore, additional biocompatibility testing, sterilization validation, software validation, electrical safety and IEC/EMC testing are not required since this information has been previously reviewed in K234039. Also, MR safety information is unchanged. The subject device and its reference device share the exact same principles of operation along with Instructions for Use and product labeling. As a result, human factors testing is not applicable to support the expanded Indications for Use. ### Real-world Clinical Evidence Real-world evidence data was provided to support the expanded Indications for Use of the subject device. The real-world evidence addressed the safety and effectiveness of the AEON™ Endoscopic Powered Stapler specific to thoracic applications. The results of the data conclude that the device is safe and effective for use for thoracic applications. ## 9. Conclusions The subject device and predicate device have the same intended use and principles of operation. The subject device, predicate device and reference device utilize the same Reloads to perform their intended use. The expanded Indications for Use, namely to include thoracic applications, is supported by real-world evidence data to demonstrate substantially equivalent safety and effectiveness of the subject device when used in thoracic applications. 510(k) Summary K251482 Page 4 of 4
Innolitics
510(k) Summary
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