(53 days)
Not Found
Not Found
No
The document describes a mechanical external fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an external fixation system intended for therapeutic purposes such as stabilizing fractures, performing osteotomies, arthrodesis, and correcting deformities.
No
The device description and intended use/indications for use clearly state that the Hoffmann® II Micro" External Fixation System is used for "stabilization of open and/or unstable fractures" and "reconstruction procedures," which are therapeutic rather than diagnostic actions.
No
The device description explicitly states it is an "external fixation frame component" and is part of an "External Fixation System," which are hardware devices used for stabilizing fractures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for stabilizing fractures and performing reconstruction procedures on bone. This is a surgical device used directly on the patient's body.
- Device Description: The description confirms it's an external fixation frame component, which is a physical device applied externally to the body to stabilize bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The Hoffmann® II Micro" External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires.
Indications for Use:
The Hoffmann® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Ostcotomy
- . Arthrodesis
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
- Compression/distraction and lengthening t
Product codes
87 KTT, 87 LXT & 87 JEC
Device Description
This line extension is to add new components to the Hoffmann ® II Micro " External Fixation System. This component is an external fixation frame component and can be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® II Micro" External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax™ External Fixation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children and adults
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Hoffmann® II Micro Line Extension
MAR 4 - 2005
iC050048
510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness for the Hoffmann® II Micro™ External Fixation System Line Extension
| Proprietary Name: | Hoffmann® II MicroTM External Fixation System |
|---|---|
| Common Name: | External Fixation Frame Components |
| Classification Name and Reference | Single/multiple component metallic bone fixation |
| appliances and accessories, 21 CFR §888.3030 and | |
| Smooth or threaded metallic bone fixation fastener, | |
| 21 CFR §888.3040 | |
| Device Product Code: | 87 KTT, 87 LXT & 87 JEC |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | January 7, 2004 |
Intended Use:
The Hoffmann® II Micro" External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires.
Description:
This line extension is to add new components to the Hoffmann ® II Micro " External Fixation System. This component is an external fixation frame component and can be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® II Micro" External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax™ External Fixation System.
Substantial Equivalence:
Equivalency is based on similarities in intended use, materials and design to the predicate devices and the mechanical performance demonstrating substantial equivalence to the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 - 2005
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K050048 Trade/Device Name: Hoffmann® II Micro™ External Fixation System Regulation Numbers: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: KTT Dated: January 7, 2005 Received: January 10, 2005
Dear Ms. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased of the enactment date of the Medical Device Amendments, or to conimeres phor to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices that have been resuire approval of a premarket approval application (PMA). and Costletter Fer (110) and the device, subject to the general controls provisions of the Act. The I va may, merelore, maniev 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 If your device is blussined too works. Existing major regulations affecting your device can may be subject to back as a submitions, 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 r rease be actived that the revilation that your device complies with other requirements of the Act that 1 DA has intact a and regulations administered by other Federal agencies. You must of any I edetar statuates and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It i att 607), laooning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manteang your as a couvalence of your device to a legally premarket noticate 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 ucate specific advice in 10-2 10-0120. Also, please note the regulation entitled, contact the Office of Comphane as (21 ) in the motification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html.
Sincerely yours,
Mark A. Millhiser
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
3
Indications for Use
510(k) Number (if known):
Device Name: Hoffmann® II Micro™ External Fixation System
Indications for Use:
The Hoffmann® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Ostcotomy
- . Arthrodesis
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
- Compression/distraction and lengthening t
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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
S10(k) Number: K050048
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