The TranSet™ Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet™ Fracture Fixation System.

The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.

Device Description

The TranSet™ Fracture Fixation System intended use is in the stabilization and linear fixation of bone or tissue fragments in orthopedic fractures and in ligament and tendon repair and reconstruction. The system consists of both absorbable and titanium cylindrical buttons manufactured from poly-L-lactic acid or titanium alloy. The buttons are provided sterile packaged with or without braided suture and are intended for single-patient use. Buttons are applied to the outer bone cortex and with suture running across the fracture site allows for stabilization and linear fixation of the bone or tissue fragments. This allows the bone or tissue fragments to be compressed and held together to promote healing. The cylindrical design of the buttons also allows them to be used as fixation devices in orthopedic ligament and tendon repair and reconstruction. The buttons are placed outside the cortical bone or though a soft tissue repair site and act as fixation posts by distributing suture tension over larger areas to promote healing and eliminate any suture tearing or pulling through the tissue. The absorbable buttons degrade over time and eliminate the need for any surgical removal. Removal of the titanium buttons is based upon surgeon preference. Reusable manual surgical instrumentation for insertion of the buttons and a sterilization tray for autoclaving complete the system.

AI/ML Overview

This document, a 510(k) summary for the TranSet™ Fracture Fixation System, focuses on demonstrating substantial equivalence to predicate devices based on intended use and material similarity, as well as mechanical strength testing. It does not contain information typically found in a study proving a device meets specific acceptance criteria related to clinical performance or algorithm-driven accuracy.

Therefore, many of the requested categories cannot be filled from the provided text.

Here is the information that can be extracted or reasonably inferred, along with notations for what is not present:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Strength and Failure Modes: Demonstrate that the TranSet™ Fracture Fixation System's absorbable and titanium buttons are statistically equivalent in mechanical strength and failure modes to stainless steel Steinmann Pins (a commonly used fracture fixation procedure). This is inferred as the core performance comparison to establish substantial equivalence.	Statistically Equivalent: "Performance testing comparing the mechanical strengths and failure modes of the TranSet™ Fracture Fixation System absorbable and titanium buttons to stainless steel Steinmann Pins commonly used in fracture fixation procedures demonstrated the buttons are statistically equivalent."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical performance testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is physical performance testing, not clinical data from patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was mechanical performance testing, not a clinical study involving expert assessment of patient outcomes or images. The "ground truth" would be the measured physical properties of the materials.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This was mechanical performance testing, not a clinical study requiring human adjudication of results.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This document describes a medical device (fracture fixation system), not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Laboratory Measured Physical Properties: The "ground truth" for the performance testing would be the objectively measured mechanical properties (e.g., tensile strength, bending strength, failure load) of the devices under controlled laboratory conditions.
The sample size for the training set:
- Not Applicable. This is not an AI or machine learning study, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "Multitak SS" in a bold, black font. Underneath the logo, in a smaller font, it says "FROM BONUTTI RESEARCH". The logo is simple and eye-catching, with the company name clearly displayed.

Ko 337/7 pge 142

FEB 2 5 2004

Bonutti Research, Inc., - TranSet™ Fracture Fixation System 510(k) Premarket Notification February 24, 2004

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is submitted in accordance with the requirements of 21 CFR 807.92:

Contact Person: Patrick G. Balsmann, MS, RAC Director RA/QA & Clinical Bonutti Research, Inc. P.O. Box 1367, Effingham, Illinois 62401 Phone: (217) 342-3412, ext. 321

Date Prepared: November 25, 2003

Proprietary Name: TranSet™ Fracture Fixation System.

Common Name: Trauma Fracture Fixation System.

· Classification Name: 21 CFR 888.3040 Smooth or threaded mctallic bone fixation fastener and 21 CFR 878.4930 Suture retention device.

Device Deseription :- The TranSet ... Frantyre Fixation System intended use is in the stabilization and linear fixation of bone or tissue fragments in orthopedic fractures and in ligament and tendon repair and reconstruction. The system consists of both absorbable and titanium cylindrical huttons manufactured from poly-L-lactic acid or titanium alloy. The buttons are provided sterile packaged with or without braided suture and are intended for single-patient use. Buttons are applied to the outer bone cortex and with suture ruming across the fracture site allows for stabilization and linear fixation of the bone or tissue fragments. This allows the bone or tissue fragments to be compressed and held together to promote healing. The cylindrical design of the buttons also allows them to be used as fixation devices in orthopedic ligament and tendon repair and reconstruction. The buttons are placed outside the cortical bone or though a soft tissue repair site and act as fixation posts by distributing suture tension over larger areas to promote healing and eliminate any suture tearing or pulling through the tissue. The absorbable buttons degrade over time and eliminate the need for any surgical removal. Removal of the titanium buttons is based upon surgeon preference. Reusable manual surgical instrumentation for insertion of the buttons and a sterilization tray for autoclaving complete the system.

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K033717 page 1 of 1

Indications for Use: The TranSct"™ Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSctTM Fracture Fixation System.

The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.

Predicate Device (s): The TranSet " Fracture Fixation System is similar in intended use and materials to the Multitak SS Buttons (K990156), Linvatec, Corp., BioButton™ (K990194) and Inion, Ltd., OTPS 10 Biodegradable pins (K031712). The TranSet 1 Fracture Fixation System buttons are also similar in design and materials to the Multitak SS Buttons and the Multitak Splinter 3.0 mm Resorbable Anchors (K012456).

Predicate Comparison: Performance testing comparing the mechanical strengths and failure modes of the TranSet™ Fracture Fixation System absorbable and titanium buttons to stainless steel Steinmann Pins commonly used in fracture fixation procedures demonstrated the buttons are statistically equivalent.

Submitted by:

[signature]

Patrick G. Balsmann, MS, RAC Director, Regulatory/Clinical Affairs & OA

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2004

Mr. Patrick G. Balsmann, MS, RAC Director, Regulatory/Clinical Affairs and Quality Assurance Bonutti Research, Inc. P.O. Box 1367 Effingham, Illinois 62401

Re: K033717

Trade/Device Name: TranSet™ Fracture Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: November 25, 2003 Received: November 28, 2003

Dear Mr. Balsmann:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 I·DA'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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Patrick G. Balsmann, MS, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maing of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac (301) 594-4639. Also, please note the regulation entitled, contact the Ories of Come to premarket notification" (21CFR Part 807.97) you may obtain. . Misorunation on your responsibilities under the Act may be obtained from the Other general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Millikum

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Koss 717 510(k) Number (if known):

TranSet™ Fracture Fixation System. Device Name:

Indications For Use:

Indications for Use: The TranSet™ Franction System is indicated as an adjunct in
there serest Indications for Use: The Transcl fracture repair involving melapliysed as an adjunct to external and intramedullary fixation are not indicated. It may also be last as an allunces and casting, and with bone
systems involving fixation plates and roline to ligners and rendon repair and systems involving fixation plates and rous, with ligament and tendon repair and graft substitutes. The system is also manages and soft tissue realtachment including reconstruction avulsions and meniscal repairs. The system consists of both absorbable and ligament/tendon avulsions and member 10 USP Size No. 5-braided sutture and are not intended
titanium fixation buttons used with up to USP Size No. 5-bration seat for tissue titanium fixation buttons used with the Unity Uitrasonic Fixation seat for tissue
for reuse. The system may also be used with the Unity 2-D through 3-baided sulure. Clust for reuse. The system may also be used with the Unity Onlines of Straided sulure. Custom
approximation and ligation when issues and as sterligation trav complete the approximation and ligation when using UST 3120 No. I 6 all 05
manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet IM Fracture Fixation System.

The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.

Prescription Use _ A (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ No (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Braluation (ODE) H. Office of Device Concurrence of CDF

Mark N. Milliken

Division of General, Restorative, and Neurological Devices

Page 1 of

Number_

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.