K Number
K121252
Device Name
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
Manufacturer
Date Cleared
2012-07-25

(91 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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. 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
Device Description
This Traditional 510(k) submission is intended to address a sterilization modification to the previously cleared Hoffmann 3 Modular External Fixation System and the addition of a new Apex Fixation Pin. The Hoffmann 3 Modular External Fixation System consists of Rods, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The additional component will be a new Apex Fixation Pin manufactured from stainless steel. The modification is to provide the previously cleared components and the additional Apex Fixation Pin as part of a sterile kit. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems and in conjunction with other commercially available Apex Pins.
More Information

No
The 510(k) summary describes a traditional external fixation system with mechanical components and a sterilization modification. There is no mention of AI or ML in the intended use, device description, or performance studies.

Yes.
The device is used to provide “stabilization of open and/or unstable fractures” and for “Bone fracture fixation”, indicating a therapeutic purpose.

No

Explanation: The device is an external fixation system used for stabilizing fractures and correcting deformities. It is a treatment device, not a diagnostic one.

No

The device description explicitly states it consists of physical components like Rods, Couplings, Clamps, and Pins, which are hardware. The submission also details non-clinical laboratory testing and engineering evaluations related to the physical properties and performance of these hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use clearly describes the device's function as providing stabilization for bone fractures, osteotomies, arthrodesis, and deformity correction. These are all procedures performed directly on the patient's body.
  • Device Description: The device is described as an external fixation system consisting of rods, couplings, clamps, and pins. These are physical components used to construct a frame for external fixation.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.

The device is a surgical implant/external fixation system used for orthopedic procedures.

N/A

Intended Use / Indications for 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 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.

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

Product codes (comma separated list FDA assigned to the subject device)

KTT

Device Description

This Traditional 510(k) submission is intended to address a sterilization modification to the previously cleared Hoffmann 3 Modular External Fixation System and the addition of a new Apex Fixation Pin. The Hoffmann 3 Modular External Fixation System consists of Rods, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The additional component will be a new Apex Fixation Pin manufactured from stainless steel. The modification is to provide the previously cleared components and the additional Apex Fixation Pin as part of a sterile kit. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems and in conjunction with other commercially available Apex Pins.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Bone

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing: Non-clinical laboratory testing and engineering evaluations were performed for the Hoffmann 3 System components to determine substantial equivalence. Testing demonstrated that the subject Hoffmann 3 System components are substantially equivalent to devices currently cleared for marketing.

The following testing was performed:

  • Corrosion Testing .
    Engineering Evaluations were completed for the following:
  • Insertion Testing .
  • . Pullout Strength Testing
  • . Rotation Testing
  • Static and Dynamic Cantilever Bending Testing .

Magnetic Resonance Environment Testing

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

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The Hoffmann 3 System is substantially equivalent to the predicate devices identified in this premarket notification.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111786 Hoffmann 3 Modular External Fixation System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K001886 Apex Fixation Pins

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

KR1252 Cpg 1/27

JUL 25 2012

510(k) Summary of Safety and Effectiveness

Proprietary Name:

Common Name:

External Fixation System

Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 8888.3030

Regulatory Class:

Class II

Product Codes:

87 KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Components

Hoffmann 3 Modular External Fixation System

For Information contact:

Estela Celi, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-6038 estela.celi(@stryker.com

Date Prepared:

April 24, 2012

Description:

This Traditional 510(k) submission is intended to address a sterilization modification to the previously cleared Hoffmann 3 Modular External Fixation System and the addition of a new Apex Fixation Pin. The Hoffmann 3 Modular External Fixation System consists of Rods, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The additional component will be a new Apex Fixation Pin manufactured from stainless steel. The modification is to provide the previously cleared components and the additional Apex Fixation Pin as part of a sterile kit. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems and in conjunction with other commercially available Apex Pins.

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.

1

Indications:

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.

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

Summary of Technologies:

Device comparison showed that the proposed device is substantially equivalent in intended use. materials and performance characteristics to the following predicate devices:

  • K111786 Hoffmann 3 Modular External Fixation System .
  • K001886 Apex Fixation Pins (reference predicate) .

Non-Clinical Testing:

Non-clinical laboratory testing and engineering evaluations were performed for the Hoffmann 3 System components to determine substantial equivalence. Testing demonstrated that the subject Hoffmann 3 System components are substantially equivalent to devices currently cleared for marketing.

The following testing was performed:

  • Corrosion Testing .
    Engineering Evaluations were completed for the following:

  • Insertion Testing .

  • . Pullout Strength Testing

  • . Rotation Testing

  • Static and Dynamic Cantilever Bending Testing .

Magnetic Resonance Environment Testing

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

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The Hoffmann 3 System is substantially equivalent to the predicate devices identified in this premarket notification.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 25 2012

Stryker Corp. Howmedica Osteonics Corp. % Ms. Estela Celi Regulatory Affairs Associate 325 Corporate Drive Mahwah. NJ 07430

Re: K121252

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: April 24, 2012 Received: April 25, 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. 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.

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

3

Page 2 - Ms. Estela Celi

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 de rece related daverse or ends) (21 CFR Part 820); and if applicable, the electronic forth in also quisions ontrol 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 n you attp://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/ReportalProblem/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 r ou may of amer generational 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

E.D. Keith

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

Enclosure

4

Indications for Use

510(k) Number (if known): _ K | 2 | 2 ≤2 (pg 1/1 )

Device Name: Hoffmann 3 Modular External Fixation System

Indications for Use:

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.

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

A

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

. 510(k) Number K121252

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

Concurrence of CDRH, Office of Device Evaluation (ODE)