(114 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional spinal fixation components, with no mention of AI/ML or related concepts.
Yes
The device is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion, which are therapeutic actions aimed at treating various spinal conditions like fractures, scoliosis, and tumors.
No
The device is described as an implant system for spinal immobilization and stabilization, functioning as an adjunct to fusion. It is a physical product designed for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components (polyaxial pedicle screws, rods, and set screws) made from titanium alloy.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Norm Spinal System is described as a "top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods and set screw." It is an implant designed to provide structural support and stabilization to the spine.
- Intended Use: The intended use is to "provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used in vivo (within the body) for structural support and stabilization, not for analyzing biological samples in vitro (outside the body).
N/A
Intended Use / Indications for Use
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; .
- 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.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine, L5-S1 vertebra
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 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.
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Image /page/0/Picture/0 description: The image shows a logo with the word "norm" in a stylized font next to a hexagonal design. Above the logo, the text "K092011 Page 1/3" is visible. The logo and text are presented in a simple, black-and-white format.
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
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.
1
2.5 INDICATION OF USE:
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; .
- 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.
3
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:
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 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_________________________________________________________________________________________________________________________________________________________________