(35 days)
Not Found
No
The document describes a mechanical external fixator for bone fractures and makes no mention of AI or ML technology.
Yes
The device is used to provide stable fracture fixation and maintain fracture reduction during the healing period, which are therapeutic functions.
No
The device is described as a "fixator" and "external fixator" intended for "stable fracture fixation" and to "obtain and maintain the fracture reduction during the healing period." This indicates it is a therapeutic device used to treat a condition, not to diagnose one.
No
The device description clearly states it is an "external fixator" and describes physical components like "bone pins," indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Fragment Specific Fixator is an external fixator designed to provide stable fracture fixation by attaching to bone pins. It is a physical device used on the body, not for testing samples from the body.
- Intended Use: The intended use is to treat distal radius fractures, which is a surgical/orthopedic application, not a diagnostic one.
Therefore, based on the provided information, the Fragment Specific Fixator is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fragment Specific fixator is intended for use in the geriatric population who have sustained an unstable extra-articular distal radius fracture that cannot be managed by casting, or a 3- or 4-part intra-articular fracture provided the medial fragment is large enough for the insertion of 2 separate 2.5mm - 3.0mm threaded cortical pins. The device can be used in a nonjoint bridging configuration which allows for immediate wrist motion during the fracture healing period of 6-8 weeks. It may alternatively be used in a joint bridging manner to provide ligamentotaxis to obtain and maintain the fracture reduction during the healing period.
Product codes
KTT
Device Description
The Fragment Specific Fixator is a single use external fixator designed to provide stable fracture fixation in a nonjoint bridging application that does not cross the wrist or in a joint bridging application that obtains and maintains fracture reduction through ligamentotaxis. The lightweight, radiolucent construct attaches to self drilling bone pins to provide secure fracture fixation and to capture fragments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
Indicated Patient Age Range
geriatric population / adult male and females from skeletal maturity
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
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
Key Metrics
Not Found
Predicate Device(s)
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
JCT 17 2005
510(k) Summary
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| Submitter: | David J. Slutsky M.D.
South Bay Hand Surgery Center
3475 Torrance Blvd., Ste F
Torrance, CA 90503 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | David J. Slutsky M.D.
Phone: (310) 792-1809
FAX: (310) 792 1811 |
| Date: | September 10, 2005 |
| Trade Name: | Fragment Specific Fixator |
| Common Name: | External Fixator |
| Classification Name: | Smooth or threaded metallic bone fixation fastener.
Single/multiple component metallic bone fixation
appliances and accessories. |
| Classification Reference: | 21 CFR 888.3040, 3030 |
| Predicate Devices: | Millennium Medical Technologies, Inc., Wristore
Distal Radius Fracture Fixator, K042761, cleared
November 17, 2004.
Howmedica Osteonics Corp., Hoffmann II Micro
External Fixation System, K050048, cleared March
4, 2005. |
| Device Description: | The Fragment Specific Fixator is a single use
external fixator designed to provide stable fracture
fixation in a nonjoint bridging application that does
not cross the wrist or in a joint bridging application
that obtains and maintains fracture reduction
through ligamentotaxis. The lightweight, radiolucent
construct attaches to self drilling bone pins to
provide secure fracture fixation and to capture
fragments. |
| Intended Use: | The Fragment Specific fixator is intended for use in |
| | the geriatric population who have sustained an
unstable extra-articular distal radius fracture that
cannot be managed by casting, or a 3- or 4-part
intra-articular fracture provided the medial fragment
is large enough for the insertion of 2 separate
2.5mm - 3.0mm threaded cortical pins. The device
can be used in a nonjoint bridging configuration
which allows for immediate wrist motion during the
fracture healing period of 6-8 weeks. It may
alternatively be used in a joint bridging manner to
provide ligamentotaxis to obtain and maintain the
fracture reduction during the healing period. |
| Comparison to Predicate Device: | The Fragment Specific Fixator has the same
intended use, has similar performance
characteristics, is manufactured from similar
materials using similar processes, and is similar in
design to the predicate devices. |
| Performance Data: | The results of non-clinical (laboratory) performance
testing demonstrate that the device is safe and
effective. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David J. Slutsky, M.D. South Bay Hand Surgery Center 3475 Torrance Boulevard, Suite F Torrance, California 90503
Re: K052498 Trade/Device Name: Fragment Specific Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bonc fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 10, 2005 Received: September 12, 2005
Dear Dr. Slutsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becomed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or 10 conniner co may 20, 1978) in accordance with the provisions of the Federal Food, Drug, de vices that have occh receasined in quire approval of a premarket approval application (PMA). and Cosmetic For (110) that the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controls proving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to back adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rouse or hose made a determination that your device complies with other requirements of the Act that 1197 has intatutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - David J. Slutsky, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated nevice 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), please in you don't office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Echeral International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincercly yours,
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Cow Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: 052498
Device Name: Fragment Specific Fixator
Indications for Use:
The Fragment Specific fixator is intended for use in adult male and females from The Tragment Openiation who have sustained an unstable extra-SKeletal maturity to the gonation in managed by casting, or a 3- or 4-part intraarticular fracture provided the medial fragment is large enough for the insertion of 2 anticular nacture provided the modial nagli pins. The device can be used in a nonjoint Separate 2.0mm - 0.0mm thrallows for immediate wrist motion during the fracture bridging configuration which allowy alternatively be used in a joint bridging manner to nealing perfou of o o woner in and maintain the fracture reduction during the healing period.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) And/Or
Over-the-Counter Use -(21 CFR 801 Subpart C)
YELEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________