degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
spondvlolisthesis
fracture
spinal stenosis
deformities (i.e., scoliosis, kyphosis, lordosis)
tumors
pseudarthrosis
failed previous fusion (pseudarthrosis)

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 by history and radiographic studies

spondylolisthesis
fracture
spinal stenosis
deformities (i.e., scoliosis, kyphosis, lordosis)
tumors
pseudarthrosis
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
receiving fusions using autogenous bone graft only
having the device fixed or attached to the lumbar and sacral spine
having the device removed after the development of a solid fusion mass.

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
fracture
dislocation
scoliosis
kyphosis
spinal turnor
failed previous fusion (pseudarthrosis)

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 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.

AI/ML Overview

This document describes the acceptance criteria and the study conducted for the ORTHOTEC, LLC. 5.0mm Spinal Screw (SCS Spinal System).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the 5.0mm Spinal Screws are based on demonstrating equivalence to the existing larger diameter screws of the SCS Spinal System in terms of mechanical and fatigue performance. The study aimed to show that the new 5.0mm screws are suitable and equivalent to the cleared larger diameter screws.

Acceptance Criteria	Reported Device Performance
Mechanical Performance	Results indicate suitability and equivalence of the new screws versus the existing larger diameter screws during static testing.
Fatigue Performance	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 in fatigue performance.
Material Compliance	Made of titanium and stainless steel per referenced specifications (316LVM ASTM F138 GR2 ISO 5832-1, TA6V ELI ASTM F136-92 ISO 5832-3). Compliance with materials standards is a special control.
Design Equivalence (except diameter)	Basic design, dimensional tolerances, materials, intended use, rod attachment method, and use of all couplers are identical to the cleared system.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the exact number of 5.0mm Spinal Screws tested. It mentions that "Samples were tested" for both static and fatigue performance.
Data Provenance: The testing was conducted internally by OrthoTec, LLC. and its submission to the FDA. The provenance can be considered retrospective in the context of the 510(k) submission, as the tests were performed to demonstrate substantial equivalence to an already marketed predicate device. The country of origin of the data is USA, where OrthoTec, LLC. is located.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This document does not involve clinical data or "ground truth" established by medical experts in the traditional sense of diagnostic or therapeutic accuracy studies. The evaluation is focused on mechanical and biocompatibility performance of a medical device (spinal screw). The "ground truth" or reference for performance is the predicate device's established performance and recognized engineering standards (ASTM). The experts involved would be engineers and material scientists responsible for conducting and interpreting the mechanical and fatigue tests and ensuring compliance with material and design standards. Their specific qualifications are not detailed but are implied by their role in conducting such tests.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical performance study, not a clinical study involving human reader interpretation or adjudication. The results are based on objective measurements from instruments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a mechanical performance study for a spinal implant, not a study assessing the effectiveness of a diagnostic or therapeutic device that requires human interpretation, nor does it involve comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant, not an algorithm or AI system. Its performance is evaluated through standardized mechanical testing, not algorithm performance.

7. Type of Ground Truth Used

The "ground truth" used for this study is primarily:

Predicate Device Performance: The established mechanical and fatigue performance of the "larger diameter cleared spinal screws of SCS Spinal System (K983353)."
Recognized Engineering Standards: Specifically, ASTM F-1717-96 guidance document for mechanical and fatigue testing. Other voluntary standards utilized include ASTM, ISO materials standards (ISO 5832-1, ISO 5832-3), and ISO 9000 series quality regulations. This provides an objective standard for performance.

8. Sample Size for the Training Set

Not applicable. This refers to a mechanical engineering study, not an AI or machine learning study, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device evaluation.

Summary

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	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 screwPedicle 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 indicationsOrthopaedic and Rehabilitation Devices PanelKWP KWQ MNH, MNI, respectively
4.	Equivalent Predicate Device:The 5.0mm Spinal Screws may be directly contrasted with the larger diameter cleared spinalscrews of SCS Spinal System, K983353. Other than the reduced major screw diameter, the 5.0mmSpinal Screws are essentially the same as the cleared spinal screws in the existing SCS SpinalSystem. 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 stainlesssteel per the referenced specifications

316LVM	ASTM F138 GR2	ISO 5832-1
TA6VELI	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.

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ScrewType	Stainless 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

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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 forUse:	As a Non-pedicle posterior system: spondylolisthesis, fracture, spinaldeformities (i.e., scoliosis, kyphosis,tumors,stenosis.lordosis).pseudarthrosis, failed previous fusion (pseudarthrosis).	SAME	YES
	As a Anterolaterallanterior system: spondylolisthesis, fracture, spinaldeformities (i.e., scoliosis, kyphosis,stenosis,lordosis).tumors.pseudarthrosis, failed previous fusion (pseudarthrosis).
	As aPosterior pedicle system: degenerative spondylolisthesis withobjective evidence of neurologic impairment, fracture, dislocation, scoliosis,kyphosis spinal tumor, failed previous fusion (pseudarthrosis). severespondylolisthesis (Grades 3 and 4) at the L5-S1 joint, Fusions usingautogenous bone graft only, Device fixed or attached to the lumbar andsacral 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

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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.

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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

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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.
1. tumors
1. 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
1. spinal stenosis
deformities (i.e., scoliosis, kyphosis, lordosis) ട്.
్. tumors
pseudarthrosis 7.
1. 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

degenerative spondylolisthesis with objective evidence of neurologic impairment ﮩ
1. fracture
1. 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.

Over-The-Counter Use (Optional format 1-2-96)

5.0mmscrew.doc

Regulation Number and Section

N/A