(83 days)
Howmedica Hoffmann® II External Fixation System
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No
The summary describes a mechanical external fixation system with no mention of software, algorithms, or any terms related to AI/ML.
Yes
Explanation: The device is intended for the "treatment of pediatric and adult fractures," which is a therapeutic purpose.
No
Explanation: The device is an external fixation system used for treating fractures, not for diagnosing them. Its purpose is to stabilize bones, not to provide diagnostic information.
No
The device description clearly outlines physical components like clamps, rods, and screws, indicating it is a hardware-based medical device system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "construction of an external fixator frame for the treatment of pediatric and adult fractures." This describes a device used on the body to stabilize bones, not a device used to test samples from the body.
- Device Description: The description details components like clamps, rods, and screws, all of which are used in surgical procedures to fix fractures. There is no mention of reagents, samples (like blood, urine, or tissue), or any kind of analysis of biological material.
- Lack of IVD Characteristics: The provided information does not include any of the typical characteristics of an IVD, such as:
- Testing of biological samples.
- Measurement of analytes or biomarkers.
- Providing diagnostic information.
This device is clearly a surgical device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Synthes (USA) Medium External Fixation System is intended for use in the construction of an external fixator frame for the treatment of pediatric and adult fractures.
Product codes
KTT
Device Description
Synthes Medium External Fixation System is a system of components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamp and the Medium Combination Clamp. Also included in the system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the clamps that allow dynamization during bone healing and double stacking of the frame, respectively. The system is used with Synthes 8.0 mm carbon fiber rods ranging in lengths from 100 - 500 mm. System pin clamps accept Schanz screws in diameters of 4.0, 4.5 and 5.0 mm.
- Materials: Clamps -Stainless steel and titanium alloy Dynamization Clip -- Stainless steel Rod Attachment - Stainless steel and titanium alloy Rods - Carbon fiber reinforced epoxy (CFRE)
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Pediatric and adult fractures.
Intended User / Care Setting
Not Found
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
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)
Howmedica Hoffmann® II External Fixation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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JUN 2 7 2001
3.0 510(k) Summary
Sponsor:
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Bonnie Smith
Synthes Medium External Fixation System Device Name:
Classification: The classification of the Synthes Medium External Fixation System is Class II, as per Title 21 of the Code of Federal Regulations, Sections 888.3030: "Single/multiple component bone fixation appliances and accessories" and 888.3040: "Smooth or threaded metallic bone fixation fastener". The instruments used with this system are considered Class I Exempt, as per 21 CFR 888.4540: "Orthopedic manual surgical instruments".
Predicate Device: The predicate device for the Synthes Medium External Fixation System is the Howmedica Hoffmann® II External Fixation System. Synthes Medium Dynamization Clip, a component accessory to the system, is similar to the currently marketed Synthes Dynamization Clip.
Synthes Medium External Fixation System is a system of Device Description: components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamp and the Medium Combination Clamp. Also included in the system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the clamps that allow dynamization during bone healing and double stacking of the frame, respectively. The system is used with Synthes 8.0 mm carbon fiber rods ranging in lengths from 100 - 500 mm. System pin clamps accept Schanz screws in diameters of 4.0, 4.5 and 5.0 mm.
The Synthes (USA) Medium External Fixation System is intended for Intended Use: use in the construction of an external fixator frame for the treatment of pediatric and adult fractures.
- Materials: Clamps -Stainless steel and titanium alloy Dynamization Clip -- Stainless steel Rod Attachment - Stainless steel and titanium alloy Rods - Carbon fiber reinforced epoxy (CFRE)
Premarket Notification 510(k): Synthes (USA) Medium External Fixation System CONFIDENTIAL
000005
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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 stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
JUN 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
Re: K011034
Trade Name: Synthes (USA) Medium External Fixation System Regulation Number: 888.3030 Regulatory Class: Class II Product Code: KTT Dated: April 4 , 2001 Received: April 5, 2001
Dear Ms. Smith:
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 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 requirement, 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.
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.
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Page 2 - Ms. Bonnie J. Smith
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" (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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mhichalairn fr
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
Enclosures
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2.0 Indications for Use Statement
Page 1 __ of __ of ___________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name:
Synthes (USA) Medium External Fixation System
INDICATIONS:
Synthes Medium External Fixation System is intended for the construction of an external fixator frame for the treatment of pediatric and adult fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109) OR
510(k) Numb
Over-the-Counter Use _
BMitchell/RAduu
(Division Sign-Off)
Division of General, Restorative Premarket Notification 510(k): Synthes (USA) Medium External Fixation System and Neurological Devices CONFIDENTIAL
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