(57 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical components for external fixation, with no mention of AI/ML or related concepts like image processing, data analysis, or algorithms.
Yes
The device is used for treating fractures and performing arthrodeses, which are therapeutic medical interventions.
No
The device is described as an external fixation system used for treating fractures, performing arthrodeses, and distraction osteogenesis, which are therapeutic interventions, not diagnostic processes.
No
The device description explicitly states the device is manufactured from Stainless Steel and is machined from bar stock, indicating it is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a surgical implant/external fixation component used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones. It is a physical component used on the body, not for testing samples from the body.
The information provided about the device's function, materials, and intended use all point to it being a medical device used in surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
This submission describes an external fixation frame component used to connect fixator rings with 6mm mounting holes to the Hoffmann® II rod to rod and pin to rod clamps. This device is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The Hoffmann® II Miami Post is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. It is to be used to provide a hybrid construct combing any 6mm external fixation ring to the Hoffmann® II rod to rod and pin to rod clamps. The post will extend the use of the Hoffmann® II External Fixation System to Hybrid frames that utilize circular rings with 6mm mounting holes.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Hoffmann® II Miami Post is designed to connect rings with 6mm holes to Hoffmann®II rod to rod and pin to rod clamps. This Post attaches the circular fixation rings to the external fixations rods. The Post is manufactured from Stainless Steel and is machined from bar stock.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
long bones, i.e., tibia, femur and humerus
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)
Testing of this device demonstrates substantial equivalence to another predicate ring system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
K9834119
510(k) Summary
Proprietary Name: Common Name: Classification Name & Reference: Requiatory Class: Device Product Code:
Hoffmann® II Miami Post External Fixation Frame Component External Fixation Device (888.3040) 21 CFR = OR(87)JEC
For information contact:
Joseph Volpe Senior Regulatory Affairs Specialist Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 Telephone: (201) 507-6695 Fax: (201) 507-6870
Date prepared: September 28, 1998
Intended use:
This submission describes an external fixation frame component used to connect fixator rings with 6mm mounting holes to the Hoffmann® II rod to rod and pin to rod clamps. This device is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
Description:
The Hoffmann® II Miami Post is designed to connect rings with 6mm holes to Hoffmann®II rod to rod and pin to rod clamps. This Post attaches the circular fixation rings to the external fixations rods. The Post is manufactured from Stainless Steel and is machined from bar stock.
Substantial Equivalence:
Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the Howmedica Monticelli/Spinelli Sliding Clamp (with articulating coupling), the Synthes Ring-to-Rod Clamp and the Zimmer Torus Ring-to-Rod Clamp.
Testing of this device demonstrates substantial equivalence to another predicate ring system.
1
Image /page/1/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV ? 5 1998
Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
Re: K983419 Hoffmann® II Miami Post Trade Name: Requlatory Class: II Product Code: HRS Dated: September 28, 1998 Received: September 29, 1998
Dear Mr. Dichiara:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. John F. Dichiara
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): Not Known
Hoffmann® II Miami Post Device Name:
Indications for Use:
The Hoffmann® II Miami Post is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. It is to be used to provide a hybrid construct combing any 6mm external fixation ring to the Hoffmann® II rod to rod and pin to rod clamps. The post will extend the use of the Hoffmann® II External Fixation System to Hybrid frames that utilize circular rings with 6mm mounting holes.
(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 (Per 21 CFR 801.109) (Optional Format 1-2-96) of General Restorative Devices
510(k) Number