(87 days)
No
The summary describes a purely mechanical external fixator system with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is described as an external fixator used for the treatment of fractures, osteotomies, and other bone conditions of the long bones, which are therapeutic interventions.
No
The device is described as an external fixator system used for treating bone conditions like fractures and osteotomies. Its function is to stabilize bones, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it consists of a "pre-assembled, mechanically adjustable, unilateral fixator" and an "accessory, the Hybrid Adaptor," both of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of bone conditions (fractures, osteotomies) using a unilateral external fixator. This is a surgical device used in vivo (within the body) to stabilize bones.
- Device Description: The description details a mechanical fixator system with clamps and an adaptor. This is consistent with a surgical implant/device, not a diagnostic test performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures. osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.
Product codes
KTT
Device Description
The Adjustable Large Fixator System consists of a pre-assembled, mechanically adjustable, unilateral fixator and an accessory, the Hybrid Adaptor. The fixator is a one-piece construct comprised of radiolucent plastic and metallic components. The vise clamps of the fixator accept 4.0-6.0 mm Schanz Screws. The Hybrid Adaptor is an accessory to the Adjustable Large Fixator that forms the connection between the fixator and the Synthes Hybrid Ring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Synthes Large External Fixator, K010344, KTT
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
MAY - 3 2001
3.0 510(k) Summary
Sponsor:
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Bonnie Smith
Device Name: Synthes Adjustable Large Fixator System
Classification: The classification of the Synthes Adjustable Large Fixator 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 Adjustable Large Fixator System is the Synthes Large External Fixator, (a pre-amendment device). The Adjustable Large Fixator System is similar in design and function to other large fixators that have received 510(k) clearance, including the EBI DynaFix™ System.
The Adjustable Large Fixator System consists of a pre-assembled, Device Description: mechanically adjustable, unilateral fixator and an accessory, the Hybrid Adaptor. The fixator is a one-piece construct comprised of radiolucent plastic and metallic components. The vise clamps of the fixator accept 4.0-6.0 mm Schanz Screws. The Hybrid Adaptor is an accessory to the Adjustable Large Fixator that forms the connection between the fixator and the Synthes Hybrid Ring.
Intended Use: The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures. osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.
Material: The Adjustable Large Fixator is comprised of PEEK resin (radiolucent material), aluminum, stainless steel and titanium alloy. The Hybrid Adaptor is comprised of titanium alloy and stainless steel.
Premarket Notification 510(k): Synthes (USA) Adjustable Large Fixator System CONFIDENTIAL
000005
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" around the perimeter. Inside the circle is an abstract image of a human figure, with three stylized profiles overlapping each other.
Public Health Service
MAY - 3 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: K010344
Trade Name: Adjustable Large Fixator System Regulation Number: 888.4540 Regulatory Class: Class II Product Code: KTT Dated: February 2, 2001 Received: February 5, 2001
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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 stated in the enorouse) to ical Device Amendments, or to devices that have been reclassified in encediance 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, condons provisions or active, 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 (Fremaries I Ippevice 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 0991 i Pactice 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 mopellish 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.
2
Page 2 - Ms. Bonnie J. Smith
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific active rolly of the ostic devices), please contact the Office of Compliance at additionally 607.10 for m This anaglestions on the promotion and advertising of your device, (201) 594-4637. Traditionally, 18. quice at (301) 594-4639. Also, please note the regulation in prease contact the Ornece or Compilance empremarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Ogden
Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
3
2.0 Indications for Use Statement
Page _ 1 of _ of _ 1 _ _ 1
510(k) Number (if known):
KOID 344
Device Name:
INDICATIONS:
The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures, osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.
NRO for cmw
(Division Sign-Off)
Synthes (USA) Adjustable Large Fixator System
Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
(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
Over-The-Counter Use
Premarket Notification 510(k): Synthes (USA) Adjustable Large Fixator System CONFIDENTIAL
000004