Tontarra Punches and Rongeurs

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 15, 2026 Tontarra Medizintechnik GmbH Andreas Birk Division Director Data and Process Management Daimlerstraße 15 Wurmlingen, BW 78573 Germany Re: K260446 Trade/Device Name: Tontarra Punches and Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: August 10, 2026 Received: August 10, 2026 Dear Andreas Birk: 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 {1} K260446 - Andreas Birk Page 2 (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). {2} K260446 - Andreas Birk Page 3 Sincerely, # EMILY L. CAPORELLO -S For Jaime Raben Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | 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. | K260446 | ? | | Please provide the device trade name(s). | | ? | | Tontarra Punches and Rongeurs | | | | Please provide your Indications for Use below. | | ? | | Tontarra Punches and Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} # K260446 510(k) Summary ## 1 Submission Sponsor and Application Correspondent ### 1.1 Applicant: TONTARRA Medizintechnik GmbH Daimlerstrasse 15 78573 Wurmlingen Germany FDA Establishment Registration No.: 9680515 ### 1.2 Contact Person Andreas Birk Division Director Data and Process Management Phone: +49 7461 965 76 76 Mail: Andreas.Birk@tontarra.de ### 1.3 Date Prepared 08 September, 2026 ## 2 Device Identification | Trade Name | Common Name | Product Code | Classification | Class | | --- | --- | --- | --- | --- | | Rongeur / Disc Rongeur / Spoon Rongeur | Rongeur, Manual | HAE | Manual Rongeur 21 CFR 882.4840 | Class II | | Punch / Cranial Punch / Ethmoid Forceps / Wave Punch | Rongeur, Manual | HAE | Manual Rongeur 21 CFR 882.4840 | Class II | | Sphenoid Punch | Rongeur, Manual | HAE | Manual Rongeur 21 CFR 882.4840 | Class II | | Revolution Punch | Rongeur, Manual | HAE | Manual Rongeur 21 CFR 882.4840 | Class II | ## 3 Predicate Device / Reference Device | Role | Device | 510(k) number | Product Code | 510(k) holder | Cleared | | --- | --- | --- | --- | --- | --- | | **Primary predicate** | Kerrison Rongeurs | K150428 | HAE | Integra York PA, Inc. | 16 April 2015 | | Reference device | Rongeurs | K092227 | HAE | Integra Medical Instrument Group | 17 February 2010 | | Reference device | Fehling Punches | K153243 | HAE | Fehling Instruments GmbH & Co. KG | 4 August 2016 | | Reference device | Steribite | K180949 | HAE | RJR Surgical Inc. | 08 November 2018 | Page 1 of 6 {5} # K260446 510(k) Summary ## 4 Device Description The TONTARRA punches and rongeurs are reusable, surgical instruments made of stainless steel that are sterilizable and packaged non-sterile. The instruments are available with following features. - - Shaft lengths from 95 mm to 330 mm - - Bite widths from 1.0 mm to 6.0 mm on punches and Kerrison-type rongeurs, which cut against a footplate - - Jaw sizes up to 7 x 12 mm on disc rongeurs, which have opposing jaws and no footplate - - Jaw openings from 9 mm to 16 mm - - 40°/90° up and down cutting angle - - Straight shaft or bayonet - - One piece, semi-detachable or with special cleanwave design - - Standard and thin foot plate - - With or without ejector - - Different surface coatings The TONTARRA punches and rongeurs are used for cutting or biting as well as removal of bone or other tissue during surgery. Each instrument consists of three main components: an ergonomically designed handle, a sliding shaft, and a working jaw. The design enables precise cutting and tissue removal while ensuring reusability after validated cleaning and sterilization procedures. By closing the hand around the handle and subsequently applying pressure, the sliding part of the punch is pushed to the distal end and the jaw is closed. By closing the jaw around the tissue, the purpose is achieved. ### 4.1 Intended Purpose Tontarra punches and rongeurs are intended to punch holes in cartilage, bone and hard and soft tissue and to remove the tissue. ### 4.2 Intended Patient Population No restrictions regarding the intended patient population are defined. ### 4.3 Indication Tontarra Punches and Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column. ### 4.4 Contraindication Tontarra Punches and Rongeurs are not intended for use on the central nervous and circulatory system. Tontarra Punches and Rongeurs are not intended for use on the cranium. The instruments may only be used for the applications described in the indication and are contraindicated for all other applications. Page 2 of 6 {6} # K260446 510(k) Summary ### 4.5 Warnings - Infection and tissue reaction due to contamination from improper implementation of validated cleaning processes - (Cross-)infection - Infection of personnel with used instruments ### 4.6 Precautions - Injury of the mucous membranes - Hemorrhage #### 4.6.1 Differences in technological characteristics The subject devices and the primary predicate have the same principle of operation, the same classification, the same jaw geometry and cut configurations, the same patient-contacting coatings and the same supplied condition. The complete side-by-side comparison of technological characteristics is presented in Section 5. The differences between the subject devices and the primary predicate are limited to the following. None of them alters the intended use, the principle of operation or the anatomical site of application, and none of them raises different questions of safety or effectiveness. | Difference | Subject devices | Primary predicate K150428 | Evaluation | | --- | --- | --- | --- | | Sliding shaft design | In addition to the standard sliding shaft, the device family includes the Clean Wave, Wave, Swing and DETATCH variants, in which the shaft can be opened or separated without tools for cleaning | Standard sliding shaft only | The difference is confined to the cleaning access of the shaft channel. Jaw geometry, force transmission, cutting principle and patient-contacting surfaces are unchanged. The concealed surface area is reduced, so reprocessability is improved rather than impaired. Cleaning and steam sterilization have been validated for these variants. | | Sterilization configuration | May be sterilized in either the assembled or the disassembled and open configuration | Disassembled and open configuration only | Labeling difference supported by a successful sterilization validation in the assembled configuration. | | Handle | Stainless steel handle; on the Wave variants a silicone-covered handle with color coding | Stainless steel handle; silicone is listed among the predicate materials | The handle is not in patient contact. Comparative testing of the manual operating force was performed. | | Materials | Stainless steels 420, 302 and 303 to ASTM F899; polyoxymethylene; silicone | Stainless steel 420; silicone; polymer components | All metallic materials conform to ASTM F899 and ISO 7153-1. The biological evaluation was performed on the final, finished device in the configurations actually marketed, in accordance with the ISO 10993 series. | Page 3 of 6 {7} # K260446 510(k) Summary | Difference | Subject devices | Primary predicate K150428 | Evaluation | | --- | --- | --- | --- | | Jaw configuration | Two configurations are offered: a working jaw closing against a footplate (punches and Kerrison-type rongeurs) and a working jaw closing against an opposing jaw on the disc rongeurs | Working jaw closing against a footplate | Both configurations are actuated by the same manual, non-powered mechanism, act on the same tissue in the same anatomical region, use the same materials and the same patient-contacting coatings, and are reprocessed by the same validated procedure. No new energy source, no new patient-contacting material and no new mode of tissue interaction is introduced. Representativeness of the tested models across both configurations is addressed in B005 | | Shaft length | 95 mm to 330 mm | 121 mm to 381 mm (4.75 to 15 inches) | The subject range extends to shorter shafts. Four models with a 95 mm shaft are offered. Jaw, footplate, stroke, handle geometry and materials are identical to the longer models of the same family. A shorter shaft reduces bending and buckling load on the sliding shaft and reduces the concealed surface available, so these models are not worst case for either mechanical performance or reprocessing and are covered by the tested worst-case specimens | | Jaw opening | 9 mm to 16 mm | 9 mm to 15.5 mm | The subject range is 0.5 mm wider at the upper end. A larger jaw opening changes neither the principle of operation nor the nature of the tissue contact; it increases the cross-section of tissue that can be taken in one bite. The models concerned are covered by the same performance, cleaning and sterilization data as the remainder of the family | ### 4.6.2 Conclusion The subject devices have the same intended use as the primary predicate K150428 and the same fundamental scientific technology. The technological differences are supported by performance, biocompatibility, cleaning and sterilization data. The subject devices are therefore substantially equivalent to the primary predicate K150428. ### 5 Device Characteristics The following table compares the subject devices with the primary predicate K150428. The subject and predicate devices have the same intended use, classification, principle of operation, and fundamental scientific technology. Technological differences do not raise different questions of safety or effectiveness. | | Tontarra Devices | Integra York PA Inc. | Integra Medical Instrument Group | Fehling Instruments GmbH & Co. KG | RJR Surgical Inc. | | --- | --- | --- | --- | --- | --- | | 510(k) | Subject of Submission | K150428 *(Predicate Device)* | K092227 *(Reference Device)* | K153243 *(Reference Device)* | K180949 *(Reference Device)* | | Product Code | HAE | HAE | HAE | HAE | HAE | | Class | II | II | II | II | II | | Regulation | 882.4840 | 882.4840 | 882.4840 | 882.4840 | 882.4840 | | Classification Name | Manual Rongeur | Manual, Rongeur | Manual, Rongeur | Manual, Rongeur | Manual, Rongeur | | Indication of Use | Tontarra Punches and | Kerrison Rongeurs are | Kerrison Rongeurs are | Fehling rongeurs (bone punches) | The Steribite® Rongeur is a | Page 4 of 6 {8} # K260446 510(k) Summary | | Tontarra Devices | Integra York PA Inc. | Integra Medical Instrument Group | Fehling Instruments GmbH & Co. KG | RJR Surgical Inc. | | --- | --- | --- | --- | --- | --- | | | Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column | manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column | manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column | are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column. | manually operated instrument indicated for cutting or biting bone during surgery involving the skull or spinal column. | | Material | 420, 302 and 303 Stainless steels, Polyoxymethylene Coatings: Titanium Nitride(TiN); Diamond Coat and HardCoat™ (TiAlN); Polymer: Silicone | 420 Stainless steel Coatings: Titanium Nitride(TiN); Diamond Coat and HardCoat™ (TiAlN); Stealth Coat and Smooth-Coat™ (Dicronite DL-5); Ultra-Coat™ (ZrN); PTFE (polytetrafluoroethylene [Teflon®]); Silicone (Elastosil® LR3003/80 A,B) | 420 Stainless steel Coatings: Titanium Nitride(TiN); Diamond Coat and HardCoat™ (TiAlN); Stealth Coat and Smooth-Coat™ (Dicronite DL-5); Ultra-Coat™ (ZrN); PTFE (polytetrafluoroethylene [Teflon®]); Silicone (Elastosil® LR3003/80 A,B) | 420 and 304 Stainless Steels; Coatings: CERAMO® (TiAlN) Polymer: Silicone | 420, 17- 4PH, 302 and 316 stainless steel; Polymer: polyacrylamide resin | | Sterility | Non-sterile, Reusable | Non-sterile, Reusable | Non-sterile, Reusable | Non-sterile, Reusable | Sterile, Single Use | | Shaft Length | 95 mm – 330 mm | 4.75 – 15" (approximately 121 mm – 381 mm) | 4.75 – 15" (approximately 121 mm – 381 mm) | 110 – 400 mm | 200 – 280 mm | | Jaw opening | 9 – 16 mm | 9 – 15,5 mm | 9 – 15,5 mm | 9 – 19 mm | - | | Jaw size, disc rongeurs | 7x12 mm | N/A | - | - | - | | Bite width, models with footplate | 1 – 6 mm | 1 – 6 mm | 1 – 6 mm | 0.8 – 8 mm 1 | 1 – 5 mm | | Jaw angles | Straight, 40° and 90° up/down | 40° and 90° up/down | 40° and 90° up/down | 40° and 90° up/down biting | 40° up-biting | ## 6 Technological Characteristics The instruments are made of stainless steel according to ASTM F899 and ISO 7153-1. Some variants are coated with an AlTiN coating. ### 6.1 Clinical performance data Clinical performance testing was not submitted in this 510(k). Page 5 of 6 {9} # K260446 510(k) Summary ## 6.2 Functional performance data To verify function and performance of the device, the following tests were conducted - Corrosion resistance testing (ASTM F1089-24) following exposure to boiling water as well as prolonged exposure to room temperature saline. - Cutting performance and mechanical stability of the device following 30,000 device actuations - Cutting force measured before and after 12,500 device actuations. - Handle strength evaluation by mechanical overload of the force required for actuation. ## 6.3 Biocompatibility The Tontarra products are categorized as devices with limited contact (≤24 h) with tissue/bone. The products were subjected to a biological evaluation according to the requirements of the ISO 10993 series of standards. All potential biological hazards arising from the materials as well as process-related circumstances were considered. The appropriate biocompatibility endpoints that were assessed include: - Cytotoxicity - Sensitization - Irritation - Acute Systematic Toxicity - Pyrogenicity ## 6.4 Cleaning – and Sterilization Validation Automated cleaning validation and a sterilization validation according to ISO 17665. ## 7 Statement of Substantial Equivalence The subject device has the same intended use as the primary predicate device and the same fundamental scientific technology. The technological differences between the subject and predicate do not raise different questions of safety and effectiveness. Performance testing, biocompatibility evaluation, cleaning validation and sterilization validation demonstrate that the subject devices are as safe and as effective as the predicate. Page 6 of 6