(106 days)
Not Found
Not Found
No
The summary describes a mechanical implant and surgical instruments for bone fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device provides fixation for osteotomies of the ulna to assist healing, which is a supportive rather than a therapeutic function.
No
Explanation: The device is described as an implant for fixation of the ulna to assist healing, not for diagnosing conditions.
No
The device description clearly states it is an implant fabricated from titanium alloy, along with screws and instruments, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "fixation for osteotomies of the ulna." This describes a surgical procedure performed directly on a patient's bone.
- Device Description: The device is described as an "implant intended for fixation of the ulna to assist healing." It's a physical object (plate and screws) implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a physical condition directly within the body.
N/A
Intended Use / Indications for Use
The DC Ulnar Shortening System provides fixation for osteotomies of the ulna.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The DC Ulnar Shortening System is an implant intended for fixation of the ulna to assist healing. The implant is fabricated from titanium alloy. It is fixated with 3.5mm fixation screws and a 3.5mm self drilling self tapping headless interfragmentary screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary for the DC Ulnar Shortening System
K073ad8 pg lot 1
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the DC Ulnar Shortening System.
Date Prepared: February 20, 2008
20 111
| 1. Submitter: | Contact Person: |
|---|---|
| OrthoPro LLC | J.D. Webb |
| 3450 Highland Dr., #303 | The OrthoMedix Group, Inc. |
| Salt Lake City, UT 84106 | 1001 Oakwood Blvd |
| Round Rock, TX 78681 | |
| Telephone: 512-388-0199 |
- Trade name: DC Ulnar Shortening System Common Name: Bone plate Classification Name: Single/multiple component metallic bone fixation appliances and accessories Class II per 21 CFR section 888.3030 HRS
3. Predicate or legally marketed devices which are substantially equivalent:
The DC Ulnar Shortening System is substantially equivalent to similar previously cleared ulnar osteotomy bone plates and screws.
4. Description of the device:
The DC Ulnar Shortening System is an implant intended for fixation of the ulna to assist healing. The implant is fabricated from titanium alloy. It is fixated with 3.5mm fixation screws and a 3.5mm self drilling self tapping headless interfragmentary screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.
Materials:
All implants in this system are made from titanium alloy Ti6Al4V for implantable devices in accordance with standard ASTM F 136.
Function:
Provide fixation for osteotomies of the ulna.
5. Intended Use:
The DC Ulnar Shortening System provides fixation for osteotomies of the ulna.
Comparison of the technological characteristics of the device to predicate and legally marketed 6. devices:
The DC Ulnar Shortening System is similar to the predicate devices in terms of indications for use, design, material, and function.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 2008
Orthopro, LLC % Mr. J. D. Webb The Orthomedix Group, Inc 1001 Oakwood Blvd. Round Rock, TX 78681
K073228 Trade/Device Name: DC Ulnar Shortening System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS
Dated: February 20, 2008 Received: February 25, 2008
Dear Mr. Webb:
Re:
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) I ms letter will and will you to organ finding of substantial equivalence of your device to a legally promatics notification. "Te 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 rr you aton Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (2007) et votification" (21CFR Part 807.97). For questions regarding postmarket surveillance, premainer nothious of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _K073228 ___________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The DC Ulnar Shortening System provides fixation for osteotomies of the ulna.
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)
Darleue Boucher
Division Sign Off
Division of G al. Restorative. and Neurological Devices
510(k) Number K023228