NORM spinal system implants are designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following indications of the thoracic, lumbar and sacral spine:

degenerative spondylolisthesis with objective evidence of neurological impairment;
fracture;
dislocation;
scoliosis;
kyphosis;
spinal tumor; and failed previous fusion (pseudarthrosis).
Levels of fixation are for the thoracic, lumbar and sacral spine.
Norm Posterior Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion.

Device Description

Norm Spinal System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods and set screw. The Norm Spinal System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Norm Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these components are available.

AI/ML Overview

The Norm Spinal System aims to provide immobilization and stabilization of spinal segments. The system's performance was evaluated through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meet Static Compressive requirements per ASTM F 1798-97	Tests conducted, results show equivalence or superiority to predicate devices.
Meet Static Torsion requirements per ASTM F 543-02	Tests conducted, results show equivalence or superiority to predicate devices.
Meet Dynamic Compressive requirements per ASTM F 2193-02	Tests conducted, results show equivalence or superiority to predicate devices.
Meet Dynamic Compressive requirements per ASTM F 1717-04	Tests conducted, results show equivalence or superiority to predicate devices.

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

The document does not explicitly state the sample size for the test set (number of devices/components tested). The tests conducted are non-clinical (mechanical) and not patient-based. Thus, there is no country of origin for human data, and the data is retrospective in the sense that it relies on standardized mechanical testing protocols rather than clinical trials.

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

Not applicable. This device's performance is demonstrated through mechanical engineering tests against ASTM standards, not expert interpretations of clinical data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Performance is determined by meeting mechanical test specifications, not through expert adjudication.

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

Not applicable. This is a spinal fixation system, not an AI-assisted diagnostic or imaging device. The study focused on mechanical performance, not human reader improvement with AI.

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

Not applicable. This device is a physical implant, not an algorithm. Its standalone performance is inherently its mechanical performance.

7. Type of Ground Truth Used

The ground truth used for evaluating the device is established by:

ASTM Standards: The mechanical tests (static compressive, static torsion, dynamic compressive) are performed according to recognized industry standards (ASTM F 1798-97, ASTM F 543-02, ASTM F 2193-02, ASTM F 1717-04). These standards define the acceptable performance parameters.
Predicate Device Performance: The primary comparative measure for "ground truth" in this 510(k) submission is the performance of legally marketed predicate devices (4S Spinal System K063708 and Optima Spinal System K031585). The Norm Spinal System is considered to meet the acceptance criteria if it performs "as well as or better than" these predicate devices.

8. Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set. The "training" for such a device would be its design and manufacturing process, optimized through engineering principles.

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

Not applicable, as there is no training set in the context of an AI/ML algorithm. The design and manufacturing processes of the device would be based on engineering principles and material science, aiming to meet the performance requirements of ASTM standards and match or exceed predicate device performance.

Summary

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SECTION 2 510 (k) SUMMARY

OCT 2 8 2009

2.1 OWNER / SUBMITTER INFORMATION:

Owner: Norm Tıbbi Ürünler İthalat İhracat Sanayi ve Ticaret Limited Şirketi Address: 1. Cad. No: 5/1 Balgat / Ankara Turkey Phone Number: +90 312 2840080 Fax Number: +90 312 2853093 Contact Person: Nuray Doğan Date Prepared: 01 July 2009

DEVICE INFORMATION: 2.2

Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name:

Spinal Fixation System Norm Spinal System Spondylolisthesis Spinal Fixation Device System and Pedicle Screw System (per 21 CFR 888.3070) MNH, MNI

Product Codes :

SUBSTANTIAL EQUIVALENCE: 2.3

Norm Spinal System is substantially equivalent to the legally marketed in function, intended use, material and design to

4S Spinal System (K063708) and Optima Spinal System (K031585).

DEVICE DESCRIPTION: 2.4

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2.5 INDICATION OF USE:

degenerative spondylolisthesis with objective evidence of neurological impairment; .
트 fracture;

dislocation; l
트 scoliosis;
트 kyphosis;
spinal tumor; and failed previous fusion (pseudarthrosis). 트

Levels of fixation are for the thoracic, lumbar and sacral spine.

Norm Posterior Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion.

STATEMENT OF TECHNICAL COMPARISON: 2.6

The summary of the technological characteristics of the Norm Spinal System compared to the predicate devices are as follows:

2.6.1 Material

The Norm Spinal System and predicate devices are fabricated by the same material that is titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F136.

2.6.2 Design

The Norm Spinal System and predicate devices have similar designed and sized components which are polyaxial screws, cylindrical longitudinal rods and set screws. Also, the Norm Spinal System and predicate devices have similar top-loading interconnection mechanism.

2.6.3 Function

The Norm Posterior Spinal System and predicate devices have similar functions which are acting as a spinal implant construct to stabilize and promote spinal fusion.

Page: 2 / 3

Norm Spinal System

NORM TIBBİ ÜRÜNLER İTHALAT İHRACAT SAN. VE TİC. LTD. ŞTİ.

This a 219 984 no 80 - 987 89 . Ender n 212 785 20 02 . www.mormitrl not No. EH Dalant Contrain / ANIVADA

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2.6.4 Level of Attachment

Levels of fixation of the Norm Posterior Spinal System are for the thoracic, lumbar and sacral spine. Similarly predicate devices are also intended to spinal segment of thoracic, lumbar and sacral.

Intended Use 2.6.5

The Norm Posterior Spinal System is indicated for the same intended uses as the predicate devices.

2.6.6 Sterility

The Norm Posterior Spinal System is supplied in non-sterile and single use. Similarly the predicate devices are supplied non-sterile and single use.

2.7 NON-CLINICAL PERFORMANCE TESTING:

Non-clinical testing including static compressive, static torsion and dynamic compressive tests according to ASTM F 1798-97, ASTM F 543-02, ASTM F 2193-02 and ASTM F 1717-04 has been conducted and the test results may be seen in Appendix 6. The result of these mechanical tests demonstrates that the Norm Spinal System is as effective, and performs as well as or better than the predicate devices and equivalent to the above predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure forming the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Norm Tibbi Urunler Ithalat Ihracat Sanayi Ve Ticar LTD. % Mr. Nuray Dogan Director of Import Department 1 Cadde No:5/1 Balgat Ankara, Turkey 06520

Re: K092011

Trade/Device Name: Norm Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: October 14, 2009 Received: October 19, 2009

OCT 2 8 2009

Dear Mr. Dugan:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2- Mr. Nuray Dogan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3- Mr. Nuray Dogan

Indications for Use

510(k) Number (if known):

Device Name: Norm Spinal System

Indications For Use:

. degenerative spondylolisthesis with objective evidence of neurological impairment;
fracture: .
dislocation; .
scoliosis; .
kyphosis:
spinal tumor; and failed previous fusion (pseudarthrosis). .

Levels of fixation are for the thoracic, lumbar and sacral spine. Norm Posterior Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K092011 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.