(27 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an anterior locking plate system intended for fixation of the spine due to various medical conditions, indicating a direct therapeutic purpose.
No
Explanation: This device is a surgical implant designed for spinal fixation, not for diagnosing medical conditions. Its purpose is to provide structural support for the spine, not to identify or characterize diseases.
No
The device description explicitly states that the system consists of multiple sized plates and screws fabricated from titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This is done outside of the body (in vitro).
- Device Description and Intended Use: The provided text describes a surgical implant (a spinal plate and screws) used for fixation of the spine within the body. It is a mechanical device used to stabilize the spine during surgery and recovery.
The device's function is entirely mechanical and involves direct interaction with the patient's anatomy, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Universal Spinal Anterior Locking Plate System is intended for anterior/anterolateral fixation for the following indications:
- degenerative disc disease (DDD) (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.
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The USA Locking Plate System consists of a multiple sized plates and screws. All components are fabricated from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the thoraco-lumbar and lumbar spine. The bone plates offer slotted and round holes that allow the bone screws to be located and securely seated in various positions. There are two plate configurations available: the straight locking plate and the narrow locking plate. The screws include the universal locking screw, the self locking screw and the cancellous locking screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoraco-lumbar and lumbar spine
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)
Engineering analyses show that the maximum allowable loads for the USA straight and narrow plates are greater than the predicate plate.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
1662686 C/ (
510(k) Summary Universal Spinal Anterior Locking Plate System
OCT = 5 2006
ﺪﻧﺴﺘﻤ ﻋﺪﺩ ﺳ
This safety and effectiveness summary for the Universal Spinal Anterior Locking Plate System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
Date Prepared: September 4, 2006
-
- Submitter: Contact Person: J.D. Webb Advanced Spine Technology, Inc. The OrthoMedix Group, Inc. 457 Mariposa St. 1001 Oakwood Blvd San Francisco, CA 94107 Round Rock. TX 78681 Telephone: 415-241-2400 Telephone: 512-388-0199
-
- Trade name: Universal Spinal Anterior Locking Plate System Common Name: anterior spinal plate Classification Name: Spinal intervertebral body fixation orthosis per CRF 888.3060 KWQ
Predicate or legally marketed devices which are substantially equivalent: 3.
- The Universal Spinal Anterior (USA) Locking Plate system is a modification to the Amset . Locking Plate (K905023).
4. Description of the device:
The USA Locking Plate System consists of a multiple sized plates and screws. All components are fabricated from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the thoraco-lumbar and lumbar spine. The bone plates offer slotted and round holes that allow the bone screws to be located and securely seated in various positions. There are two plate configurations available: the straight locking plate and the narrow locking plate. The screws include the universal locking screw, the self locking screw and the cancellous locking screw.
5. Intended Use:
The Universal Spinal Anterior Locking Plate System is intended for anterior/anterolateral fixation for the following indications:
- degenerative disc disease (DDD) (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.
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
The design and indications are similar. The main difference is the change of material from 316L stainless steel to Ti-6Al-4V titanium alloy.
7. Summary of Nonclincal Tests
Engineering analyses show that the maximum allowable loads for the USA straight and narrow plates are greater than the predicate plate.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 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 forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 5 2006
Advanced Spine Technology, Inc % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K062686
Trade/Device Name: Universal Spinal Anterior Locking Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 4, 2006 Received: September 8, 2006
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. Iisting 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, and 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation on ); plan "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) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Rabaue Buchur
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
19 //
1062686
510(k) Number (if known):
Device Name:
Indications for Use:
Spinal Anterior Locking Plate System is intended for Universal The anterior/anterolateral fixation for the following indications:
- degenerative disc disease (DDD) (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.
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bishop
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062646