(128 days)
Not Found
No
The summary describes a mechanical spinal implant system made of titanium alloy. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The device description focuses on the material, design, and intended use for physical stabilization.
Yes
The device is described as providing "stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities," which are therapeutic actions.
No
The device is described as a "spinal system" intended for "posterior pedicle screw fixation" to provide "stabilization and immobilization of spinal segments as an adjunct to fusion." Its purpose is to treat various spinal instabilities or deformities, such as trauma, curvatures, and tumors. This description clearly indicates a therapeutic or reconstructive function, not a diagnostic one. Diagnostic devices are used to identify or detect a disease or condition, whereas this device is used in the treatment of such conditions.
No
The device description explicitly states the device is made of Titanium Alloy and is intended for posterior pedicle screw fixation, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This is done outside of the body (in vitro).
- Device Description: The provided text describes a surgical implant (spinal system) made of titanium alloy. It is intended for posterior pedicle screw fixation directly within the patient's body to stabilize the spine.
- Intended Use: The intended use clearly states it's for posterior pedicle screw fixation and provides stabilization and immobilization of spinal segments. This is a surgical procedure performed in vivo (within the body).
The device is a surgical implant used to treat structural issues in the spine, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Trauson General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-VII can be applied for anterior or anterolateral fixation) of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
When used as a posterior spine thoracic/lumbar system, Trauson General Spinal System (GSS) is indicated for one or more of the following: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis.
Trauson General Spinal System (GSS) is not intended for pedicle screw fixation above T8.
Product codes
MNH, MNI
Device Description
The applicant device of Trauson General Spinal System (GSS) made of Titaniuim Alloy (Ti-6AL-4V) that meet ASTM 136 is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients.
The applicant devices are not provided sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.
All variants use the same material, same design principle and are constant thickness.
No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine, posterior spine thoracic/lumbar
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)
Performance tests demonstrate that the specifications of the proposed device meet its design input.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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K082617
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Exhibit #D 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) Number is: K082617
Proposed Device 1.
Trade/Proprietary Name: Trauson General Spinal System (GSS)
Common Name: Pedicle screw spinal system
Classification Name:
Orthosis, Spondyloisthesis spinal fixation (MNH)
Orthosis, Spinal pedicle fixation (MNI)
Device Class: II
Product Code: MNH, MNI
Regulation Number: 21 CFR 888.3070
Intended Use:
Trauson General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-VII can be applied for anterior or anterolateral fixation) of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
When used as a posterior spine thoracic/lumbar system, Trauson General Spinal System (GSS) is indicated for one or more of the following: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis.
Trauson General Spinal System (GSS) is not intended for pedicle screw fixation above T8.
2. Sponsor Information
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
31 Houcun Road, Niutang Town
Changzhou, Jiangsu, 213163, CHINA
Phone: +86-757-86280075
Fax: +86-757-86397179
Submission Correspondent
Ms. Diana. Hong, Mr. Lee. Fu
Shanghai Mid-link Consulting Co., Ltd.
Suite 8D, No.19, Lane 999, Zhongshan No.2 Road(S)
Shanghai, China, 200030
- Predicate Device JAN 1 5 2009
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K082617
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PILOT(0) Spinal System (K063601) Device Name: PILOT™ Spinal System Common Name: Pedicle screw spinal system Classification Name: 21 CFR 878.3070 Pedicle Screw Spinal System Product Code: MNI: Orthosis, Spinal, Pedical Fixation MNH: Orthosis, spondylolis thesis spinal fixation Sponsor: Life Spine 2400 Hassell Road, Suite 370 Hoffman Estates, IL 60195 Telephone: 847-884-6117 Fax: 847-884-6118
4. Device Description
The applicant device of Trauson General Spinal System (GSS) made of Titaniuim Alloy (Ti-6AL-4V) that meet ASTM 136 is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients.
The applicant devices are not provided sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.
All variants use the same material, same design principle and are constant thickness.
No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.
ಳು Test Conclusion
Performance tests demonstrate that the specifications of the proposed device meet its design input.
6. Substantially Equivalence
The applicant device is Substantially Equivalent (SE) to the predicate device in tems of Effectiveness and Safety.
2
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Trauson (Jiangsu) Medical Instrument Co., Ltd. % Shanghai Midlink Business Consulting Co., Ltd Ms. Diana Hong Lane 999, Zhongshan No. 2 Road Suite 8D, No 19 Shanghair China
JAN 1 5 2009
Re: K082617
Trade/Device Name: Trauson General Spinal System (GSS) Regulation Number: 21 CFR 888.3070 Regulation Namc: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: November 19, 2008 Received: November 21, 2008
Dear Ms. Hong:
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 cnclosure) 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 such additional controls. Existing major regulations all'ecting your device can be found in the Codc 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 complics 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Diana Hong
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRII's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
IIFZ-401 DMC cc:
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K082617
Page 1 of 1
Exhibit # A Indication for Use
510(k) Number: K082617 Device Name: Trauson General Spinal System (GSS)
Indications for Use:
Transon General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-VII can be applied for anterior or anterolateral fixation) of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
When used as a posterior spine thoracic/lumbar system, Trauson General Spinal System (GSS) is indicated for one or more of the following: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pscudarthrosis, (6) spinal stenosis.
Trauson General Spinal System (GSS) is not intended for pedicle screw fixation above T8.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C
Page 1 of __ 1
(Division Sign-l Division of General, Restorative, and Neurological Devices
510(k) Numb
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