(112 days)
No
The 510(k) summary describes a spinal screw, a mechanical device, and focuses on its material, dimensions, and mechanical performance testing. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device, the 5.0mm Spinal Screws, is part of a larger SCS Spinal System, which is indicated for a wide range of conditions like degenerative disk disease, spondylolisthesis, fracture, spinal stenosis, and deformities, all of which aim to treat existing medical conditions.
No.
This device, the SCS Spinal System, is described as an implantable system (screws, rods, etc.) used for immobilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. It is a therapy device, not a diagnostic one. Its purpose is to treat, not to diagnose.
No
The device description clearly states it is a physical medical device (spinal screws made of titanium and stainless steel) and describes mechanical testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed 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 that this device is a "Spinal System" consisting of "Spinal Screws" made of titanium and stainless steel. These are physical implants used in surgical procedures.
- Intended Use/Indications for Use: The intended uses are for treating various spinal conditions like degenerative disk disease, spondylolisthesis, fracture, etc., through surgical intervention and fusion. This involves implanting the device directly into the patient's spine.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
- degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed ﻬﺎ by history and radiographic studies
- spondvlolisthesis 2.
- fracture 3.
- spinal stenosis র্য .
- deformities (i.e., scoliosis, kyphosis, lordosis) 5.
-
- tumors
-
- pseudarthrosis
- failed previous fusion (pseudarthrosis) 8.
When used as an anterolaterallanterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed 1. by history and radiographic studies
- spondylolisthesis 2.
- fracture స్
-
- spinal stenosis
- deformities (i.e., scoliosis, kyphosis, lordosis) ട്.
- ్. tumors
- pseudarthrosis 7.
-
- failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:
- having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint ﮩ
- receiving fusions using autogenous bone graft only 2.
- having the device fixed or attached to the lumbar and sacral spine ని.
- having the device removed after the development of a solid fusion mass. য
Posterior pedicle systems are intended to provide immobilization 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:
- degenerative spondylolisthesis with objective evidence of neurologic impairment ﮩ
-
- fracture
-
- dislocation
- scoliosis র্ধ .
- ട്. kyphosis
- spinal turnor 6.
- failed previous fusion (pseudarthrosis) 7.
Product codes
MNH, KWQ, KWP, MNI
Device Description
The 5.0mm Spinal Screws . The new diameter screws are made of titanium and stainless steel per the referenced specifications. The product is manufactured in the same facility as the other components of the SCS Spinal System following identical manufacturing procedures in full compliance with cGMP regulations.
The 5.0mm Spinal Screws facilitates screw insertion by providing an alternative to the larger 6, 6.5 or 7.0mm pedicle screws or vertebral screws available in the cleared system. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the small size of the pedicle would not permit insertion of larger diameter screws. The smaller diameter of the 5.0mm Spinal Screws permits the surgeon to address the needs of a larger patient population.
The 5.0mm Spinal Screws are to be a new "standard" screw for the SCS Spinal System with an identical coding for product reference in which "xx" represents the length of the screw. 2010. represents the reference for stainless steel products and 2T10 represents the reference for titanium products. The new screw will be used in all SCS Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical characteristics of mechanical and fatigue performance are important. The balance of the SCS Spinal System components will remain the same. Other than the major and minor diameter of the cancellous threads the new 5.0mm screws are identical to the existing screws. Rod attachment method and the use of all couplers are the same as were previously cleared for commercialization. Materials are identical.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine, thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
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
Mechanical and fatigue testing were carried out. Samples were tested using the ASTM F-1717-96 guidance document. Tests were performed with an Instron 8500 digital Materials Test System. The maximum and minimum loads, positions and temperatures were recorded. Static testing sufficient to quantify and compare the other previously cleared screw of the SCS Spinal System are complete. Testing was conducted to run-out points of 5,000,000 cycles. Results indicate suitability and equivalence of the new screws versus the existing larger diameter screws.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| Summary of Safety and Effectiveness Information | ORTHOTEC, LLC. | ||
|---|---|---|---|
| Premarket Notification, Section 510(k) | DECEMBER 1999 | ||
| Regulatory Authority: | Safe Medical Devices Act of 1990. 21 CFR 807.92 | ||
| 1. | Device Name: | ||
| Trade Name: | |||
| Common Name(s): | |||
| Classification Name(s): | 5.0mm Spinal Screw (SCS Spinal System) | ||
| pedicle screw | |||
| Pedicle Screw Spinal System (Class II Uses) | |||
| 2. | Establishment Name & Registration Number: | ||
| Name: | |||
| Number: | ORTHOTEC, LLC. | ||
| 2031734 | |||
| 3. | Classification: | § 888.3050 - Spinal Interlaminal Fixation Orthosis | |
| § 888.3060 - Spinal Intervertebral Body Fixation Orthosis | |||
| § 888.3070 – Spondylolisthesis Spinal Fixation Device System | |||
| § 888.3070 - Pedicle Screw Spinal System (Class II Uses) | |||
| Device Class: | |||
| Classification Panel: | |||
| Product Code(s): | Class II for the requested indications | ||
| Orthopaedic and Rehabilitation Devices Panel | |||
| KWP KWQ MNH, MNI, respectively | |||
| 4. | Equivalent Predicate Device: | ||
| The 5.0mm Spinal Screws may be directly contrasted with the larger diameter cleared spinal | |||
| screws of SCS Spinal System, K983353. Other than the reduced major screw diameter, the 5.0mm | |||
| Spinal Screws are essentially the same as the cleared spinal screws in the existing SCS Spinal | |||
| System. The basic design, dimensional tolerances, materials and intended use are identical. | |||
| 5. | Device Description: | The 5.0mm Spinal Screws . The new diameter screws are made of titanium and stainless | |
| steel per the referenced specifications |
| 316LVM | ASTM F138 GR2 | ISO 5832-1 |
|---|---|---|
| TA6V | ||
| ELI | ASTM F136-92 | ISO 5832-3 |
The product is manufactured in the same facility as the other components of the SCS Spinal System following identical manufacturing procedures in full compliance with cGMP regulations.
The 5.0mm Spinal Screws facilitates screw insertion by providing an alternative to the larger 6, 6.5 or 7.0mm pedicle screws or vertebral screws available in the cleared system. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the small size of the pedicle would not permit insertion of larger diameterscrews. The smaller diameter of the 5.0mm Spinal Screws permits the surgeon to address the needs of a larger patient population.
The 5.0mm Spinal Screws are to be a new "standard" screw for the SCS Spinal System with an identical coding for product reference in which "xx" represents the length of the screw. 2010. represents the reference for stainless steel products and 2T10 represents the reference for titanium products.
1
| Screw
Type | Stainles
s Steel | Titanium |
|---------------|---------------------|---------------|
| R | 2010-
R5xx | 2T10-
R5xx |
| V | 2010-
V5xx | 2T10-
V5xx |
| L | 2010-
L5xx | 2T10-
L5xx |
| S | 2010-
S5xx | 2T10-
S5xx |
| U | 2010-
U5xx | 2T10-
U5xx |
| H | 2010-
H5xx | 2T10-
H5xx |
The new screw will be used in all SCS Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical characteristics of mechanical and fatigue performance are important. The balance of the SCS Spinal System components will remain the same. Other than the major and minor diameter of the cancellous threads the new 5.0mm screws are identical to the existing screws. Rod attachment method and the use of all couplers are the same as were previously cleared for commercialization. Materials are identical
Testing Summary:
Mechanical and fatigue testing were carried out. Samples were tested using the ASTM F-1717-96 guidance document. Tests were performed with an Instron 8500 digital Materials Test System. The maximum and minimum loads, positions and temperatures were recorded. Static testing sufficient to quantify and compare the other previously cleared screw of the SCS Spinal System are complete. Testing was conducted to run-out points of 5,000,000 cycles. Results indicate suitability and equivalence of the new screws versus the existing larger diameter screws.
Applicant Name & Address: દ.
ORTHOTEC, LLC. 546 Hillgreen Drive Beverly Hills. CA 90212-4110 310.557.2000 ~ 310.843.9500 - fax
7. Company Contact:
Requiatory Affairs ORTHOTEC. LLC. 546 Hillgreen Drive Beverly Hills, CA 90212-4110 310.557.2000 ~ 310.843.9500 - fax
8. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, LLC. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
9. Performance Standards:
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality
2
regulations. ORTHOTEC, LLC. In addition, meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
10. Special Controls:
Special controls were published in the Federal Register, Vol. 63, No. 143, July 27, 1998 (Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems). The following special controls apply to the marketing of this device when used as a posterior pedicle system:
- Compliance with material standards, (i)
- (ii) Compliance with mechanical testing standard.
- Compliance with biocompatability standard, and (iii)
- Compliance with specified labeling requirements. (iv)
Special Guidance Document Information: 11.
The 510(k) was prepared in accordance with:
- . "Guidance for Spinal System 510(k)'s," May 7, 1999.
- "The New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence . in Premarket Notifications - Final Guidance, March 20, 1998.
12. Storage, Packaging & Sterilization Information:
The Omniaxial Connector is supplied "NON-STERILE" and must be sterilized before use. The recommended sterilization process is high temperature steam autoclave sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10 °
The validated cycle is:
Method: Steam Cycle: Gravity Temperature: 250°F (121°C) Exposure Time: 30 minutes
13. Summary Comparison Table:
| FEATURE | SCS Spinal System OmniAxial Connector | SCS Spinal System | SE? |
|---|---|---|---|
| Indications for | |||
| Use: | As a Non-pedicle posterior system: spondylolisthesis, fracture, spinal | ||
| deformities (i.e., scoliosis, kyphosis, | |||
| tumors, | |||
| stenosis. | |||
| lordosis). | |||
| pseudarthrosis, failed previous fusion (pseudarthrosis). | SAME | YES | |
| As a Anterolaterallanterior system: spondylolisthesis, fracture, spinal | |||
| deformities (i.e., scoliosis, kyphosis, | |||
| stenosis, | |||
| lordosis). | |||
| tumors. | |||
| pseudarthrosis, failed previous fusion (pseudarthrosis). | |||
| As a | |||
| Posterior pedicle system: degenerative spondylolisthesis with | |||
| objective evidence of neurologic impairment, fracture, dislocation, scoliosis, | |||
| kyphosis spinal tumor, failed previous fusion (pseudarthrosis). severe | |||
| spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, Fusions using | |||
| autogenous bone graft only, Device fixed or attached to the lumbar and | |||
| sacral spine, device removed after the development of a solid fusion mass. | |||
| Design: | Omniaxial pedicle screw | SAME | YES |
| Sterile: | Non-sterile | SAME | YES |
| Sizes: | 5.0mm __ | 6-7mm dia | YES |
| Material: | Stainless steel, titanium alloy, pure titanium | SAME | YES |
| Manufacturer: | Ortho Tec, LLC. | OrthoTec, LLC. | YEs |
| Product Code: | KWP KWO & MNH | SAME | YES |
| K - Number: | pending | K983353 | YES |
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 eagle or bird-like symbol with three curved lines representing the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2000
Mr. David W. Schlerf OrthoTec, L.L.C. c/o Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389
Re: K994288 Trade Name: SCS Spinal System Regulatory Class: II Product Code: MNH, KWQ, KWP, and MNI Dated: March 15, 2000 Received: March 22, 2000
Dear Mr. Schlerf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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.
This letter will allow you to begin marketing your device as described in your 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.
4
Page 2 - Mr. David W. Schlerf
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,
Jechner.
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
5
Page 1
510(k) Number :
5. Omm Spinal Screws (SCS Spinal System) Device Name(s):
Intended Use(s) of the Device:
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
- degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed ﻬﺎ by history and radiographic studies
- spondvlolisthesis 2.
- fracture 3.
- spinal stenosis র্য .
- deformities (i.e., scoliosis, kyphosis, lordosis) 5.
-
- tumors
-
- pseudarthrosis
- failed previous fusion (pseudarthrosis) 8.
When used as an anterolaterallanterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed 1. by history and radiographic studies
- spondylolisthesis 2.
- fracture స్
-
- spinal stenosis
- deformities (i.e., scoliosis, kyphosis, lordosis) ട്.
- ్. tumors
- pseudarthrosis 7.
-
- failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:
- having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint ﮩ
- receiving fusions using autogenous bone graft only 2.
- having the device fixed or attached to the lumbar and sacral spine ని.
- having the device removed after the development of a solid fusion mass. য
Posterior pedicle systems are intended to provide immobilization 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:
- degenerative spondylolisthesis with objective evidence of neurologic impairment ﮩ
-
- fracture
-
- dislocation
- scoliosis র্ধ .
- ട്. kyphosis
- spinal turnor 6.
- failed previous fusion (pseudarthrosis) 7.
please do not write below this line - continue on another page if necessary Concurrence of CDRH, Office of Device Evaluation (ODE)
Dune R. Lochner.
Division of General Restorative Devices 510(k) Number 4994288
Image /page/5/Picture/38 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font. There is a line through the words "Prescription Use". The text is likely related to medical or pharmaceutical information.
OR
Over-The-Counter Use (Optional format 1-2-96)
5.0mmscrew.doc