(22 days)
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No
The document describes a mechanical external fixation system component and its intended use for stabilizing fractures. There is no mention of software, algorithms, or any technology related to AI or ML. The modification is described as addressing manufacturing issues.
Yes
The device is used in external fixation frames to provide stabilization of fractures, osteotomy, arthrodesis, and correction of deformity, which are all therapeutic interventions aimed at treating a medical condition.
No
The device is described as an external fixation system used to stabilize fractures and correct deformities, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "Hoffmann® II Hybrid Clamp" which is a physical component of an external fixation system, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as part of an external fixation system used for stabilizing bone fractures, osteotomies, arthrodesis, and correcting deformities. These are all procedures performed on the patient's body.
- Device Description: The description mentions a clamp being modified for manufacturing issues, consistent with a physical medical device used externally.
- Lack of IVD Indicators: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests in vitro (outside the body) on samples taken from a patient. This device is used in vivo (on the body) as part of a surgical or orthopedic procedure.
N/A
Intended Use / Indications for Use
The Hoffmann® II Hybrid Ring Clamp was determined substantially equivalent via 510(k) K000197.
This subject component, when used together with the components of the Hoffmann® II and/or Monotube® TRIAX™ External Fixation Systems and Apex® Pins, creates an external fixation frame construct. The subject device is intended to be used in the construction of external fixation frames to provide 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 Hybrid External Fixation System is intended to be used in conjunction with the Apex™ Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX™ External Fixation System.
This device 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 indications for use of metallic 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)
LXT
Device Description
The Hoffmann® II Hybrid Clamp is being modified to address issues in manufacturing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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.
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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).
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§ 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
JUL 1 3 2001
Special 510(k) Premarket Notification
Summary of Safety and Effectiveness Hoffmann® II Hybrid Ring Clamp
Submission Information
Name and Address of the Sponsor of the 510(k) Submission
Contact Person:
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677 Karen Ariemma Regulatory Affairs Specialist June 20, 2001
Hoffmann® II Hybrid Ring Clamp External Fixation Frame Component Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030
Predicate Device Identification
The Hoffmann® II Hybrid Ring Clamp was determined substantially equivalent via 510(k) K000197.
Device Description
The Hoffmann® II Hybrid Clamp is being modified to address issues in manufacturing.
Intended Use:
This subject component, when used together with the components of the Hoffmann® II and/or Monotube® TRIAX™ External Fixation Systems and Apex® Pins, creates an external fixation frame construct. The subject device is intended to be used in the construction of external fixation frames to provide 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.
Statement of Technological Comparison:
Analysis demonstrates comparable properties of the subject to the predicate device.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2001
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401
Re: K011948
Trade/Device Name: Hoffmann® II Hybrid Ring Clamp Regulation Number: 888.3030 Regulatory Class: II Product Code: LXT Dated: June 20, 2001 Received: June 21, 2001
Dear Ariemma:
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 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). 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.
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 - Ms. Karen Ariemma
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 regulation (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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Mark N. Melkerson
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
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510(k) Number (if known): Koj 1948
Device Name: Hoffmann® II Hybrid Frame System
Indications For Use:
The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex™ Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX™ External Fixation System.
This device 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 indications for use of metallic 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 .
(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) |
for Mark Milliken (Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K011948 |
|---|---|
| --------------- | --------- |