(34 days)
Not Found
No
The device description focuses on mechanical components (hooks, rods, screws) and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench tests, not clinical studies involving data analysis.
Yes
The device is a spinal fixation system intended to treat various spinal conditions, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, and tumors, aiming to correct or alleviate these conditions.
No
The device is described as a "Spinal Hook and Rod System" used for fixation in surgical procedures for various spinal conditions, not for diagnosing them.
No
The device description explicitly states it consists of physical components like hooks, rods, set screws, and connectors made from titanium alloy, and requires specialized instruments for application and removal. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The U & I Spinal Hook and Rod System is a physical implant used within the body (in vivo) to provide structural support and fixation to the spine. It is a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the U & I Spinal Hook and Rod System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The U & I Spinal Hook and Rod System can be used in coniunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The U&I America, Spinal Hook System ™ is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Spinal Hook System ™ implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The U&I America, Spinal Hook System ™ can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The U&I America, Spinal Hook System ™ design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic (spinal) location and orientation.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Spinal Hook System ™ implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical, nonpedicle (spinal)
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)
Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices.
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.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
JUN 2 4 2003
K031595 ' of 3
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Submission Information:
Classification Name:
| | Contact: | Patrick Moore
Manager, Quality Assurance |
|------------------------|-----------------------------|----------------------------------------------------------------------------------------------------|
| | Sponsor: | U&I America
6132 South 380 West
Murray, UT 84107
Phone: 801.262.3100
Fax: 801.262.3151 |
| | Date Prepared: | June 11, 2003 |
| Device Identification: | | |
| | Trade Name:
Common Name: | U&I America, Spinal Hook System™
Spinal Hook System |
Appiliance, Fixation, Spinal Interlaminal (KWP) per 21 CFR ട്ട് 888.3050
Spinal Hook System
Substantially Equivalent Predicate Legally Marketed Devices:
United States Surgical Corporation, Rogozinski Spinal System – KWP, MNH, MNI, KWQ -- (K983804) Cotrel-Dubousset (CD™) Spinal system -- MNH, MNI, KWQ, KWP -- (K001319, K955807)
The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices.
1
K031595 2 cm 3 Device Description:
The U&I America, Spinal Hook System ™ is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Spinal Hook System ™ implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The U&I America, Spinal Hook System ™ can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The U&I America, Spinal Hook System ™ design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic (spinal) location and orientation.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Spinal Hook System ™ implants.
From the foregoing, we conclude that the subject U&I America, Spinal Hook System ™ device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications.
Indications for Use:
The U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The U & I Spinal Hook and Rod System can be used in coniunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.
Statement of Technological Comparison:
The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles.
2
Image /page/2/Figure/0 description: The image shows the alphanumeric string 'K031595' on the top line. Below that, there is a handwritten line that reads '3 c4 3'. The characters in the second line are less clear and appear to be handwritten digits with a possible letter in the middle.
Performance Data:
Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three flowing lines representing the department's services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2003
Mr. Patrick Moore Manager, Quality Assurance U&I America 6132 South 380 West, Suite 200 Murray, Utah 84107
Re: K031595
Trade Name: U&I America, Spinal Hook System™ Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: May 16 and June 10, 2003 Received: May 21 and June 12, 2003
Dear Mr. Moore:
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
4
Page 2 - Mr. Patrick Moore
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours.
sincerely yours,
L. Mark N. Millerm
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
5
K031595, Spinal Hook System Additional Information:
510(k) Number (if known): K031595
Device Name: U&I America, Spinal Hook System ™
Indications for Use:
The U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The U & I Spinal Hook and Rod System can be used in conjunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-the-Counter Use_ _____________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96)
Mark A. Mikkelsen
vision Sign-Off) sion of General, Restorative Neurological Devices
s. (k) Number -