(63 days)
No
The summary describes a mechanical external fixation device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "external fixation device" or "external fixator" intended for the "treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality." The purpose of treating bone conditions clearly indicates a therapeutic function.
No
The document describes an external fixation device used for treating bone conditions, not for diagnosing them. Its function is to stabilize and support bones during healing and repair, not to identify or characterize diseases or conditions.
No
The device description explicitly states it includes various size frames, bars, pin clamps, pins, accessories, and instruments, which are physical hardware components of an external fixation system.
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 treatment of bone conditions through external fixation. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device components (frames, bars, clamps, pins) are all physical components used to stabilize and manipulate bone externally.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical/orthopedic device used for treatment.
N/A
Intended Use / Indications for Use
The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
Product codes
JWD
Device Description
The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JUL 17 1998
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
May 13, 1998 Prepared: Avanta Orthopaedics, Inc. Applicant: 9369 Carroll Park Drive, Suite A San Diego, CA 92121
Telephone: 619-452-8580 619-452-9945 Fax: Contact: Louise M. Focht
Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number
External Fixator External Fixator Class II Orthopaedic 888.3040 Smooth or threaded metallic bone fixation fastener. JWD
Product Code: Accessories Predicate Device:
Avanta Orthopaedics (K974911) EBI/Orthofix K831576
Device Description:
The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Intended Use:
The intended use of the external fixation device is the same as that expressed in the predicate device 510k.
1
The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
Comparison to Predicate Device:
The table below summarizes similarities and differences between the EBI/Orthofix and the Avanta Orthopaedics external fixator.
| Feature | EBI/Orthofix | Avanta Orthopaedics |
|---|---|---|
| Pins | Implantable | Implantable |
| Allows for application of | ||
| compression or distraction | Yes | Yes |
| Pin Length | 80-160 mm | 50-90 mm |
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The eagle is facing right, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 1998
Ms. Louise M. Focht Avanta Orthopaedics, Inc. 9369A Carroll Park Drive San Diego, California 92121
K981716 Re: Trade Name: External Fixator Requlatory Class: II Product Code: JWD May 13, 1998 Dated: Received: May 15, 1998
Dear Ms. Focht:
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 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 In addition, FDA may publish further announcements action. 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. Louise M. Focht
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 advertisinq 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 Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K981716
Device Name: External Fixation
Intended Use:
The intended use of the external fixation device is the same as that expressed in the predicate device 510k.
The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
boolefo
sion Sign-Off
of General Restorative Devices K981716
Number
Prescription Use
(Per 21 CFR 801.109)
X