(77 days)
Not Found
Not Found
No
The summary describes a mechanical external fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as "intended to provide stabilization of open and/or unstable fractures" and for "reconstruction procedures", which are therapeutic actions.
No
The device is an external fixation system used for stabilizing fractures and performing reconstruction procedures, not for diagnosing conditions.
No
The device description clearly states it is an external fixation frame system with physical components (Foot Ring components, Fixation Pins, Kirschner Wires), indicating it is a hardware device, not software-only.
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 the stabilization and fixation of bone fractures and for reconstruction procedures. This is a mechanical function performed directly on the patient's body.
- Device Description: The device is described as an external fixation frame system with components like rings, pins, and wires. These are physical components used to hold bones in place externally.
- 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 (inside or on the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Hoffmann ® II Hybrid Frame System is intended to provide stabilization of open and/or unstable fractures 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 .
- . Osteotomy
- . Arthrodesis
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Bone reconstruction procedures .
- Fusions and replantations of the foot .
- Charcot foot reconstruction and Lisfranc dislocations .
Product codes (comma separated list FDA assigned to the subject device)
87 KTT
Device Description
The new Foot Ring components are additions to the Hoffmann ® II Hybrid Frame System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax " External Fixation System and in conjunction with commercially available Fixation Pins such as the Apex® Pins and/or Kirschner Wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Testing has been conducted on the Hoffmann® II Foot Ring components demonstrating substantial equivalence to the predicate devices.
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.
Not Found
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.
Not Found
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
Hoffmann* II Foot Ring
SEP = 8 2004
510(k) Summary of Safety and Effectiveness for the Hoffmann® II Foot Ring
K041706
page 1 of 1
| Proprietary Name: | Hoffmann® II Foot Ring |
|---|---|
| Common Name: | External Fixation Frame Component |
| Classification Name and Reference | Single/multiple component metallic bone fixation |
| appliances and accessories, 21 CFR §888.3030 | |
| Device Product Code: | 87 KTT |
| 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: | June 21, 2004 |
Intended Use:
The Hoffmann ® II Hybrid Frame System is intended to provide stabilization of open and/or unstable fractures 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.
Description:
The new Foot Ring components are additions to the Hoffmann ® II Hybrid Frame System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax " External Fixation System and in conjunction with commercially available Fixation Pins such as the Apex® Pins and/or Kirschner Wires.
Substantial Equivalence:
Equivalency is based on similarities in intended use, materials and design to the predicate devices. Testing has been conducted on the Hoffmann® II Foot Ring components demonstrating substantial equivalence to the predicate devices.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K041706 Trade/Device Name: Hoffmann® II Foot Ring Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 21, 2004 Received: June 23, 2004
Dear Ms Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assumer in 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 r ou mayy atests 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 11 your de rice to such additional controls. Existing major regulations affecting your device can may be subject to back additions, 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 as made a determination that your device complies with other requirements of the Act that I Dr Had Intatutes and regulations administered by other Federal agencies. You must or any I odolar statutes 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 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.
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 with anow you to ogen manieming of substantial equivalence of your device to a legally premarket notheadon: "The PDF mailing sification 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 spocente arrivier J at (301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Comphalled at (58 r otification" (21CFR Part 807.97). You may obtain Misolanding by release to premaintention 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/dsma/dsmamain.html
Sincerely yours,
Mark H. Mellema
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): K041706
Device Name: Hoffmann® II Foot Ring
Indications for Use:
The Hoffmann ® II Hybrid Frame System is intended for use to provide stabilization of open and/or unstable fractures 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 .
- . Osteotomy
- . Arthrodesis
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Bone reconstruction procedures .
- Fusions and replantations of the foot .
- Charcot foot reconstruction and Lisfranc dislocations .
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __
(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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K041706