(20 days)
No Predicate Device(s) K/DEN numbers were found in the text.
Not Found
No
The description focuses on material and size modifications to an external fixation system, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for the "stabilization of open and/or unstable fractures", which is a therapeutic purpose.
No
Explanation: The device is an external fixation system used for stabilizing fractures, which is a treatment, not a diagnostic, function.
No
The device description explicitly states it is fabricated from stainless steel and aluminum, and describes physical components like pins and rods, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "stabilization of open and/or unstable fractures." This is a direct treatment of a physical condition within the body.
- Device Description: The description details a system of external fixation components made of stainless steel, designed to be used with pins for fracture stabilization. This is a mechanical device used externally on the body.
- 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 to perform tests on samples from the body, not to directly treat a physical condition like a fracture.
N/A
Intended Use / Indications for Use
The Hoffmann® II Micro External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
Product codes
JEC, LXT
Device Description
This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Hoffmann® II Compact" External Fixation System. The subject device, named the Hoffmann® II Micro External Fixation System, is a line extension of the Hoffmann® II Compact External Fixation System. The predicate Hoffmann® II Compact External Fixation System is fabricated from stainless steel and aluminum. The subject Hoffmann® II Micro External Fixation System is fabricated from stainless steel. The Hoffmann® II Micro External Fixation System is a miniaturization of the Hoffmann® II Compact "External Fixation System. The miniaturization involves modifying the overall size of the components as well as reducing the size of the mating components (Apex® pins and connecting rods).
The subject Hoffmann® II Micro External Fixation System shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II Compact™ External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components.
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
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
Mechanical testing demonstrated comparable mechanical properties to the predicate components.
Key Metrics
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
DEC 0 3 2001
Kol 3772
page 1 of 1
Summary of Safety and Effectiveness Line Extension to the Hoffmann® II Compact™External Fixation System
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
59 Route 17 Allendale, NJ 07401-1677
Howmedica Osteonics Corp
Karen Ariemma Regulatory Affairs Specialist
Date of Summary Preparation:
November 8, 2001
Device Identification
| Proprietary Name: | Hoffmann® II Micro External Fixation System
(formerly the Hoffmann® II Compact™ External
Fixation System) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Frame Component |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation
fastener. 21 CFR §888.3040 |
This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Hoffmann® II Compact" External Fixation System. The subject device, named the Hoffmann® II Micro External Fixation System, is a line extension of the Hoffmann® II Compact External Fixation System. The predicate Hoffmann® II Compact External Fixation System is fabricated from stainless steel and aluminum. The subject Hoffmann® II Micro External Fixation System is fabricated from stainless steel. The Hoffmann® II Micro External Fixation System is a miniaturization of the Hoffmann® II Compact "External Fixation System. The miniaturization involves modifying the overall size of the components as well as reducing the size of the mating components (Apex® pins and connecting rods).
The subject Hoffmann® II Micro External Fixation System shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II Compact™ External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components.
1
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 stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CEC 0 3 2001
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401
Re: K013772
Trade/Device Name: Hoffman® II Micro External Fixation System Regulation Number: 888.3040, 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JEC, LXT
Dated: November 8, 2001 Received: November 13, 2001
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 11 Jour device to such additional controls. Existing major regulations affecting your device can may or bagges to been an arraderal 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 r reaso or hour 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 or any I vith 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 Of It in the quality systems (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. Karen Ariemma
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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 vours.
for Mark N Milliman
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
510(k) Number (if known): K Ol 377 x
Device Name: Hoffmann® II Micro External Fixation System (line extension to the Hoffmann® II Compact™ External Fixation )
Indications For Use:
The Hoffmann® II Micro External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
KO134 42
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark N. Milliman
Division of General, Restorative and Neurological Devices
510(k) Number -