(30 days)
Not Found
No
The summary describes a mechanical bone plate system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to augment fracture healing, which is a therapeutic purpose.
No
The device is described as a system for augmenting fracture healing by bringing together bone fragments, which indicates a therapeutic rather than diagnostic function.
No
The device description explicitly states it consists of physical components like titanium bone plates, screws, and instrumentation, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist, and hand." This describes a surgical implant used directly on the patient's body to provide structural support and aid in the healing process.
- Device Description: The device consists of "titanium bone plates," "titanium bone screws," and "associated instrumentation." These are all components used in surgical procedures, not for testing samples outside of the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests in vitro (in glass or outside the living organism)
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used in vivo (within the living organism).
N/A
Intended Use / Indications for Use
The UBP System III is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist, and hand.
Product codes
HRS
Device Description
The UBP III System consists of single and multi-segmented titanium bone plates of various sizes and lengths, titanium bone screws in 3.5 and 4.0mm diameters and various lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws through the openings in the plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the foot, wrist, and hand.
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)
Mechanical testing data were collected to verify the design changes. Static and fatigue data were provided to demonstrate that the design changes met design requirements.
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
MAR 2 7 2002
Universal Bone Plate III System 510(k) SUMMARY
| Submitted by: | Spinal Concepts, Inc.
12012 Technology Blvd.
Suite 100
Austin, TX 78727 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David M. Hooper, Ph.D.
Manager, Clinical & Regulatory Affairs |
| Establishment
Registration Number: | 1649384 |
| Classification Name: | Single/multiple component metallic bone fixation appliances
and accessories. (87HRS) |
| Device Classification: | Class II |
| Common Name: | Titanium Bone Plate and Screws |
| Date prepared: | February 22, 2002 |
| Predicate Device | SCI Universal Bone Plate II System (K973586). This is a design
modification per established design control procedures. |
DEVICE DESCRIPTION
The UBP III System consists of single and multi-segmented titanium bone plates of various sizes and lengths, titanium bone screws in 3.5 and 4.0mm diameters and various lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws through the openings in the plate.
INTENDED USES/INDICATIONS
The UBP System III is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist, and hand.
MECHANICAL TEST DATA
Mechanical testing data were collected to verify the design changes. Static and fatigue data were provided to demonstrate that the design changes met design requirements.
12012 Technology Blvd., Suite 100 Austin, Texas 78727
Spinal Concepts, Inc.
Fhone: 512-918-2700 Fax: 512-918-2784
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, with the words separated by dots.
MAR 2 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David M. Hooper, Ph.D. Manager, Clinical and Regulatory Affairs Spinal Concepts, Inc. 12012 Technology Boulevard, Suite 100 Austin, Texas 78727
Re: K020611
Trade/Device Name: Universal Bone Plate III System (UBP III) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: February 22, 2002 Received: February 26, 2002
Dear Dr. Hooper:
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 - Dr. David Hooper
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 vours.
for Mark N Milkman
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
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INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known): Ko20611
Device Name:
Spinal Concepts, Inc. Universal Bone Plate III System
Indications for Use:
The UBP System III is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist, and hand.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Pcr 21 CFR 801.109)
OR
1
Over-The-Counter (Optional Format 1/2/96)
Mark N Millkur
Division Six 08
Division Sig Off Division of Caleral, Restorative and Neurolog cal Devices
510(k) Number: K020611