(170 days)
Not Found
Not Found
No
The device description focuses solely on the physical components of a spinal fixation system (screws, rods, hooks, etc.) and their dimensions and materials. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
Yes
The device is described as a spinal system intended for various spinal indications such as degenerative disc disease, spondylolisthesis, trauma, and scoliosis, which are conditions that require medical treatment. The use of screws, hooks, and rods for fixation in the spine directly implies a therapeutic function to treat these conditions.
No
The device described is a spinal system consisting of various implants (screws, hooks, washers, spacers, rods, plates) intended for surgical fixation of the spine in conditions like degenerative disc disease, spondylolisthesis, trauma, etc. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly lists physical components such as screws, hooks, washers, spacers, rods, and rod plates/screws, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "spinal system consisting of screws, hooks, washers, spacers, rods, and rod plates/screws." These are physical implants used in surgical procedures.
- Intended Use/Indications for Use: The intended uses and indications all relate to surgical fixation and stabilization of the spine for various conditions like degenerative disc disease, spondylolisthesis, trauma, etc. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used to treat spinal conditions, not to diagnose them by testing samples.
N/A
Intended Use / Indications for Use
-
- The device system consisting of screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses:
- (a) anterolateral screw lixation to the non-cervical spine,
- (h) anterior screw fixation to the cervical spine
The anterolateral/anterior system is intended for use in the following indications: - (a) Degenerative dise disease of the lumbar thoracic and cervical spinc relating to Degenerative thise disease of the disc as confirmed by patient history and radiouraphic studies.
- (b) Spondylolisthesis
- (c) Trauma
- (d) Spinal Stenosis
- (c) Scolinsis
- (f) Kyphosis
- (g) Tumor
- (h) Pscudoarthrosis
- (i) Revision of previous surgery
- (j) Neoplastia
-
The device system consisting of hooks, serews, washers, spacers, when utilized as a non-pedicle posterior system has the following intended use:
- (a) hook and sacral/iliac screw fixation to the non-cervical spine
The non-pedicle posterior devices may be used for the following indications: - Degencrative disc discase of the lumbar thoracic and cervical spine relating to ( = ) discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
- Spondylolisthesis (b)
- Trauma (c)
- Spinal Stenosis (ત)
- Scolinsis (c)
- Kyphosis (1)
- Tumor ( u)
- Pscudoarthrosis (11)
- Revision of previous surgery (i)
- Neoplastia (i)
- (a) hook and sacral/iliac screw fixation to the non-cervical spine
-
The device system consisting of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients:
- (a) Having a severe spondylolisthesis (grades 3 and 4) at the LS-SI joint
- (b) Who are receiving fusions using autogenous hone graft only
- (c) Who are having the device fixed or attached to the lumbar and sacral spinc
- (d) Who are having the device removed after the development of a solid fusion mass
The levels of pedicle screws fixation will be L3-S1.
Product codes (comma separated list FDA assigned to the subject device)
MNH, KWP and KWQ
Device Description
A spinal system consisting of screws, hooks, washers, spacers, rods, and rod plates/screws. The pedicle screws are available in four diameters from 5mm to 8mm, and vary in length from 30mm to 55mm. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The anterior washers offer use with 5mm, 6mm, and 7mm screws. The Conical spacers are available in three heights from 7mm to 12mm, increasing in 2.5mm increments. The lumbo-sacral rod/plate and screw incorporates lumbo-sacral rod/plates in three lengths from 80mm to 120mm, and bone screws with a 7mm diameter and lengths of 30mm to 45mm, increasing in 5mm increments. There are five laminar hooks and one pedicle hook within the range. The system is intended for use anterolateral/anterior, non-pedicle posterior and posterior pedicie. The distal tips of the pedicle screws are fluted to a point beyond the first thread, thus creating a self-tapping screw configuration. The pedicle screw longths are offered in 5mm increments from 30mm to 55mm. The screw diameters are offered in 1mm increments from 5mm to 8mm diameters. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The locking mechanism hetween the rod and screw, as well as the rod and hook, features a three point clamping configuration in order to significantly reduce the risk of rod pistoning and migration. The devices are manufactured from titanium alloy or stainless steel. All components are completely interchangeable with each other, but only components manufactured from the same material may be used in combination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, non-cervical spine, cervical spine, lumbar thoracic and cervical spine, LS-SI joint, L3-S1, L5-S1 vertebral joint
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
1973425
FEB 2 7 1998
510(k) SUMMARY
Name of Company:
Corin Spinal Systems Ltd. The Corinium Centre Cirencester Gloucestershire GL7 IYJ Fingland
Name of Device:
Device Description:
The Corin Spinal System
A spinal system consisting of screws, hooks, washers, spacers, rods, and rod plates/screws. The pedicle screws are available in four diameters from 5mm to 8mm, and vary in length from 30mm to 55mm. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The anterior washers offer use with 5mm, 6mm, and 7mm screws. The Conical spacers are available in three heights from 7mm to 12mm, increasing in 2.5mm increments. The lumbo-sacral rod/plate and screw incorporates lumbo-sacral rod/plates in three lengths from 80mm to 120mm, and bone screws with a 7mm diameter and lengths of 30mm to 45mm, increasing in 5mm increments. There are five laminar hooks and one pedicle hook within the range.
The system is intended for use anterolateral/anterior, non-pedicle posterior and posterior pedicie.
The distal tips of the pedicle screws are fluted to a point beyond the first thread, thus creating a self-tapping screw configuration.
The pedicle screw longths are offered in 5mm increments from 30mm to 55mm. The screw diameters are offered in 1mm increments from 5mm to 8mm diameters.
The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm.
The locking mechanism hetween the rod and screw, as well as the rod and hook, features a three point clamping configuration in order to significantly reduce the risk of rod pistoning and migration.
The devices are used to treat a number of spinal conditions listed as follows:
INDICATIONS FOR USE
-
- The device system consisting of screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses:
- (a) anterolateral screw lixation to the non-cervical spine,
- (h) anterior screw fixation to the cervical spine
1
The anterolateral/anterior system is intended for use in the following indications:
- (a) Degenerative dise disease of the lumbar thoracic and cervical spinc relating to Degenerative thise disease of the disc as confirmed by patient history and radiouraphic studies.
- (b) Spondylolisthesis
- (c) Trauma
- (d) Spinal Stenosis
- (c) Scolinsis
- (f) Kyphosis
- (g) Tumor
- (h) Pscudoarthrosis
- (i) Revision of previous surgery
- (j) Neoplastia
- The device system consisting of hooks, serews, washers, spacers, when utilized as a non-pedicle posterior system has the following intended use:
-
(a) hook and sacral/iliac screw fixation to the non-cervical spine
The non-pedicle posterior devices may be used for the following indications: -
Degencrative disc discase of the lumbar thoracic and cervical spine relating to ( = ) discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
-
Spondylolisthesis (b)
-
Trauma (c)
-
Spinal Stenosis (ત)
-
Scolinsis (c)
-
Kyphosis (1)
-
Tumor ( u)
-
Pscudoarthrosis (11)
-
Revision of previous surgery (i)
-
Neoplastia (i)
-
The device system consisting of hooks, spacers, sacral/iliac screws and pedicle 3. screws is intended for patients:
-
(a) Having a severe spondylolisthesis (grades 3 and 4) at the LS-SI joint
-
(b) Who are receiving fusions using autogenous hone graft only
-
(c) Who are having the device fixed or attached to the lumbar and sacral spinc
-
(d) Who are having the device removed after the development of a solid fusion mass
The levels of pedicle screws fixation will be L3-S1.
The anterior washers can be used with either the 5mm, 6mm, or 7mm screws.
The Conical spacers are available in three heights, 7mm, 9.5mm, and 12mm.
2
The lumbo-sacral rod plate and screw incorporates lumbo-sacral rod plates with 80mm, 100mm, and 120mm rod lengths, as well as screws of a 7mm diamctor and lengths that range from 30mm to 45mm, in 5mm increments.
The devices are manufactured from titanium alloy or stainless steel. All components are completely interchangeable with each other, but only components manufactured from the same material may be used in combination.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 1998
Mr. Craig Corrance President Corin USA 10500 University Center Drive Suite 190 Tampa, Florida 33612
Re: K973425
Corin Spinal System Regulatory Class: II Product Codes: MNH, KWP and KWQ Dated: December 16, 1997 Received: December 22, 1997
Dear Mr. Corrance:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act (Act). This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.
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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f)(1) of the Act.
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
4
Page 2 - Mr. Craig Corrance
- All labeling for this device, including the package label, must state that there are 1. labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device system for pedicular, screw 2. fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS:
- When used as a pedicle screw system, this device system is intended only for ● grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- The screws of this device system are not intended for insertion into the ● pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- Benefit of spinal fusions utilizing any pedicle screw fixation system has not ● been adequately established in patients with stable spines.
- Potential risks identified with the use of this device system, which may require additional surgery, include:
- device component fracture, loss of fixation. non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
-
- Any pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
-
- Any previous warning statements identified as part of previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
5
Page 3 - Mr. Craig Corrance
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K97 342
INTENDED USE
INDICATIONS FOR USE
- The device system consisting screws, washers, spacers, utilizing the 1. I he device system ocubioming so rough is intended for the following uses:
- (a) anterolateral screw fixation to the non-cervical spine,
- (b) anterior screw fixation to the cervical spine
The anterolateral/anterior system is intended for use in the following indications:
- (a) Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
- (b) Spondylolisthesis
- (c) Trauma
- (d) Spinal Stenosis
- (c) Scoliosis
- (f) Kyphosis
- (g) Tumor
- (h) Pseudoarthrosis
- (i) Revision of previous surgery
- (i) Neoplastia
- The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicle posterior system has the following intended use:
hook and sacral/iliae screw fixation to the non-cervical spines of the con-(a)
The non-pedicle posterior devices may be used for the following indications:
- Degenerative disc discase of the lumbar thoracic and ccrvical spinc relating to (¿ı) discogenic origin with degeneration of the dise as confirmed by patient history and radiographic studies.
- Spondylolisthesis (b)
- Trauma (c)
- Spinal Stenosis (d)
- Scoliosis (୯)
- Kyphosis (t)
- Tumor (g)
- Pseudoarthrosis (h)
- Revision of previous surgery (i)
- Neoplastia (i)
Prescription Use
(Per 21 CFR 801.109)
tcoer
7
P.OG
- The device system consisting of hooks, spacers, sacral/iliac screws and pedicte screws is intended for patients:
(a) Having a severe spondyloslisthesis (grades 3 and 4) at the [.5-SI joint
(b) Who are receiving fusions using autogenous bone graft only
(0) Who are having the device fixed or attached to the lumbar and sacral spine
(c) Who are having the device removed aller the development of a solid fusion mass
The levels of pedicte screws fixation will be 1.3-S1.
Prescription Use
(Per 21 CFR 801.109)