The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, in conjunction with Apex Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

Device Description

The Hoffmann 3 Modular External Fixation System consists of Rods, Posts, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The components for the subject device where manufactured from a variety of materials including austentic steel, titanium, and a Vectran coating. This line extension is intended to add additional components for connecting rods and fixed posts, design and material modifications to the couplings, pin clamp, rods and posts. Although the Hoffmann II MRI External Fixation System will continue to be marketed, the Hoffmann 3 Modular External Fixation System will be available with additional components for connecting rods and include design and material modifications to the couplings, pin clamp, rods and posts.

AI/ML Overview

{"1. A table of acceptance criteria and the reported device performance": "The document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes a comparative evaluation against a predicate device. The "reported device performance" is stated as demonstrating "comparable mechanical properties to the predicate components" and that the system "could be safely used in Magnetic Resonance Imaging under predetermined conditions."\n\nAcceptance Criteria (Implied from testing and claim of substantial equivalence):\n* Mechanical Properties: Comparable to the Hoffmann II MRI System's mechanical properties.\n* Magnetic Resonance Environment Safety: Safe for use in MRI under predetermined conditions (Radio Frequency Heating, Force and Torque, Artifact).\n\nReported Device Performance:\n* Mechanical testing demonstrated comparable mechanical properties to the predicate components.\n* Testing in a Magnetic Resonance Environment established that the Hoffmann 3 Modular External Fixation System could be safely used in Magnetic Resonance Imaging under predetermined conditions. (Specific results like % difference or specific thresholds are not provided in this summary.)", "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document refers to "Non-Clinical Testing" and lists various mechanical and MRI environment tests. However, it does not specify the sample sizes used for these tests. There is no mention of human subject data, and thus no data provenance in terms of country of origin or retrospective/prospective studies are applicable for the type of testing described.", "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "This section is not applicable. The study described is non-clinical performance testing of a medical device (external fixator system) and does not involve the establishment of ground truth by human experts in the context of diagnostic interpretation. The 'ground truth' for this type of device would relate to engineering standards and safety parameters established by regulatory bodies or industry best practices, not expert consensus on medical images or patient outcomes.", "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts to establish a consensus ground truth. The tests performed for this device were non-clinical mechanical and MRI compatibility tests.", "5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an external fixation system, not a diagnostic imaging or AI-assisted device. The testing described focuses on the mechanical and MRI compatibility of the hardware components.", "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This question is not applicable to the Hoffmann 3 Modular External Fixation System as it is a physical medical device, not an algorithm or AI system. There is no 'standalone' algorithm performance to report.", "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the non-clinical testing of this external fixation system, the 'ground truth' would be based on established engineering and material science principles, industry standards (e.g., for strength, bending, torsion, pull-out, rotation), and regulatory requirements for MRI compatibility (radio frequency heating, force and torque, artifact). It's not based on expert consensus, pathology, or outcomes data related to clinical diagnosis.", "8. The sample size for the training set": "This question is not applicable to the Hoffmann 3 Modular External Fixation System. This device is a physical medical hardware system, not a machine learning model or software that requires a 'training set.' The listed tests are non-clinical hardware performance tests.", "9. How the ground truth for the training set was established": "This question is not applicable, as there is no 'training set' for this physical medical device."}

Summary

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K111786 (pg. 1 of 3)

JAN 2 6 2012

: Summary of Safety and Effectiveness Hoffmann 3 Modular External Fixation System

Proprietary Name:	Hoffmann 3 Modular External Fixation System
Common Name:	External Fixation System
Classification Name and Reference:	Single Multiple component metallic bone fixation appliance and accessories, 21 CFR §888.3030
Regulatory Class:	Class II
Product Codes:	87 KTT: Appliance, Fixation, Nail/Blade/Plate Combination,Multiple Components
Predicate Devices:	Hoffmann II MRI External Fixation System
For Information contact:	Estela Celi, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6461 Fax: (201) 831-6038estela.celi@stryker.com
Date Prepared:	October 5, 2011

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K111786 (pg. 2 of 3)

Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the Hoffmann 3 Modular External Fixation System as a line extension to the currently marketed Hoffmann II MRI External Fixation System. The Hoffmann 3 Modular External Fixation System consists of Rods, Posts, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The components for the subject device where manufactured from a variety of materials including austentic steel, titanium, and a Vectran coating. This line extension is intended to add additional components for connecting rods and fixed posts, design and material modifications to the couplings, pin clamp, rods and posts. Although the Hoffmann II MRI External Fixation System will continue to be marketed, the Hoffmann 3 Modular External Fixation System will be available with additional components for connecting rods and include design and material modifications to the couplings, pin clamp, rods and posts.

Intended Use

The Hoffmann 3 Modular External Fixation System is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

The indications for use of external fixation devices include:

Bone fracture fixation .
. Osteotomy
. Arthrodesis
. Correction of deformity
. Revision procedure where other treatments or devices have been unsuccessful
Bone reconstruction procedures .

Indications for Use

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K111786 (pg. 3 of 3)

Summary of Technologies

Device comparisons showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the Hoffmann II MRI System, previously cleared in K051306, K053038, and K053472. The subject Hoffmann 3 Modular External Fixation System components share the same intended use and basic design concepts as that of the currently available Hoffmann II MRI External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components. Testing in a Magnetic Resonance Environment established that the Hoffmann 3 Modular External Fixation System could be safely used in Magnetic Resonance Imaging under predetermined conditions.

Non-Clinical Testing

Non-clinical laboratory testing was performed on the Hoffmann 3 Modular External Fixation System to determine substantial equivalence. The following testing was performed:

Frame Testing .
. Bending Strength Testing
Torsion Strength Testing .
. Pull-Out Testing
. Rotation Strength Testing

Magnetic Resonance Environment Testing

Radio Frequency Heating Testing .
Force and Torque Testing .
. Artifact Testing

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Estela Celi Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

JAN 2 6 2012

Re: K111786

Trade/Device Name: Hoffmann 3 Modular External Fixation System Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories.

Regulatory Class: Class II Product Code: KTT Dated: January 9, 2012 Received: January 10, 2012

Dear Ms. Celi:

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 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 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 803); good manufacturing practice requirements as set

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Page 2 - Ms. Estela Celi

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yo

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Hoffmann 3 Modular External Fixation System

Indications for Use:

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ta V. Shegti

for (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111786

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.