(55 days)
Not Found
No
The description focuses on the mechanical components and function of an external fixation device, with no mention of AI or ML.
Yes
The device is used to stabilize fractures and assist with limb lengthening and deformity correction, which are therapeutic interventions.
No
Explanation: The device description clearly states its purpose is to "stabilize open and/or unstable fractures of long bones," "joint fusions and limb lengthening," and "correction of bony deformities." These are all therapeutic and structural support functions, not diagnostic ones. There is no mention of it being used to detect, identify, or monitor medical conditions.
No
The device description explicitly states it is a "ring component of an external fixation device" and is fabricated from "beryllium-aluminum alloy rings encased in an injection-molded polycarbonate plastic," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to stabilize bone fractures, perform joint fusions, and correct bony deformities. These are all procedures performed on the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a physical component of an external fixation device used to stabilize bones. This is a surgical/orthopedic device, not a diagnostic tool that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
Product codes
KTT
Device Description
This device is the ring component of an external fixation device. Pin/wire clamps and distractors are attached to the ring to complete a rigid construct utilized to stabilize long bone fractures or in limb lengthening or correction of bony deformities. These rings are fabricated from two beryllium-aluminum alloy rings encased in an injection-molded polycarbonate plastic.
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)
This device has similar load carrying capabilities as solid rings made of aluminum alloy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Date July 17, 2002
Submitter
RIGID FX Orthopedics, Inc 3601 South Congress Ave. Bldg B, Suite 300 Austin, TX 78704
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-4694
Common name
External Fixation Frame Component
Classification name
Single/multiple component metallic bone fixation appliances and accessories (per 21 CFR section 888.3030)
Equivalent Device
| Device | Company/510(k) | Description | Intended Use |
|---|---|---|---|
| Hoffman II Hybrid | |||
| Frame System | Howmedica Osteonics/ | ||
| K000957 | Carbon fiber rings to receive | ||
| various pin clamps and distractors | *see below | ||
| Ilizarov External | |||
| Fixation System | Smith & Nephew | Aluminum and carbon fiber rings | |
| to receive various pin clamps and | |||
| distractors | *see below | ||
| TrueLok | Encore Medical, L.P./ | ||
| K941048 | Aluminum rings to receive various | ||
| pin clamps and distractors | *see below | ||
| Taylor Spatial | |||
| Frame External | |||
| Fixation System | Smith & Nephew/K970748 | Carbon fiber rings to receive | |
| various pin clamps and distractors | *see below |
Device Description
This device is the ring component of an external fixation device. Pin/wire clamps and distractors are attached to the ring to complete a rigid construct utilized to stabilize long bone fractures or in limb lengthening or correction of bony deformities. These rings are fabricated from two beryllium-aluminum alloy rings encased in an injection-molded polycarbonate plastic.
Intended Use
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
Summary of Technological Characteristics Compared to Predicate Device
Material of this device is beryllium-aluminum alloy other devices are fabricated from aluminum alloy or carbon fiber composite.
Summary Nonclinical Tests
This device has similar load carrying capabilities as solid rings made of aluminum alloy.
SFP 1 7 2002
1
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 or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2002
Rigid RX Orthopedics, Inc. J. D. Webb c/o J. D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Rc: K022423
Trade/Device Name: External Fixation Ring Regulation Number: 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: July 17, 2002 Received: July 24, 2002
Dear Mr. Webb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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.
2
Page 2 – Mr. J. D. Webb
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 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
R. Galin M. Witter, Ph.D., M.D.
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
3
510(k) number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: External Fixation Ring
Indications for Use:
External Fixation Ring Indications for Use
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use -
(Optional format 1-2-96)
)
(Division Sign-off) Division of General, Neurological and Restorative Devices
Mark A. Miller 510(k) Number __
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number _