(69 days)
The R-X-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies.
The R-X-Fix External Fixator is a stable solution for fractures and for lengthening of small bones. The R-X-Fix External Fixator is hinged to allow adjustment in horizontal or vertical axis and is used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The hinge system allows range of motion at the joint during treatment. The design allows the placement of pins to be adjusted around three orthogonal axes and translated linearly.
This document describes a 510(k) submission for the R-X-Fix External Fixator, a medical device. It does not contain information about acceptance criteria or a study proving device performance against such criteria.
The provided text does not include any information regarding acceptance criteria, device performance metrics, or any study conducted to demonstrate the device meets specific criteria. The document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against quantified acceptance criteria through a clinical or non-clinical study.
Specifically:
- There is no table of acceptance criteria or reported device performance.
- No sample size for test sets or data provenance is mentioned.
- No information about experts, adjudication methods, or MRMC studies is present.
- Standalone algorithm performance is not applicable as this is a mechanical device.
- No ground truth type is mentioned.
- No training set size or ground truth establishment for a training set is provided.
The document indicates "Non-clinical Testing None," which further confirms the absence of performance data from a study. The 510(k) clearance is based on substantial equivalence to predicate devices (Orthofix Dynamic Axial Fixation system and Fixano Minifix Fixator), rather than demonstrating specific performance metrics.
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510(k) Summary R-X-Fix External Fixator
| Date | April 19, 2004 |
|---|---|
| Submitter | R-X-Fix3450 Highland Dr., #303Salt Lake City, UT 84106 |
| Contact person | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 |
| Trade Name | R-X-Fix External Fixator |
| Common name | External fixator |
| Classification name | appliance, fixation, nail/blade/plate combination, multiple componentClass II per 21 CFR section 888.3030 |
| Product Code | KTT |
| Equivalent Device | Orthofix Dynamic Axial Fixation system (K955848)Fixano Minifix Fixator (K964094) |
Device Description
The R-X-Fix External Fixator is a stable solution for fractures and for lengthening of small bones. The R-X-Fix External Fixator is hinged to allow adjustment in horizontal or vertical axis and is used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The hinge system allows range of motion at the joint during treatment. The design allows the placement of pins to be adjusted around three orthogonal axes and translated linearly.
Intended Use
The R-X-Fix External Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies. The system allows precise, controlled compression/distraction and early weight bearing.
Non-clinical Testing None
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle or bird, with three distinct lines forming its body and wings.
Public Health Service
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
R-X-Fix C/o Mr. J.D. Webb Orthomedix Group Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K051017 Trade/Device Name: R-X-Fix External Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 19, 2005 Received: April 21,2005
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.
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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), please contact the 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 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/industry/support/index.html.
Sincerely yours.
A. Hyt Rhodes
Miriam C. Provost, Ph.D. 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 (if known): _____________________
Device Name: _R-X-Fix External Fixator
Indications for Use:
The R-X-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt Rurdes
Sign-Of (Division Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.