(131 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to immobilize and stabilize spinal segments to treat various acute and chronic instabilities or deformities, which is a therapeutic function.
No
Explanation: The device is a spinal implant system used for stabilization and immobilization, not for diagnosing medical conditions.
No
The device description explicitly lists physical components like screws, rods, and crosslink members, indicating it is a hardware-based medical device.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a surgical implant system used to stabilize the spine. It consists of screws, rods, and crosslink members that are physically implanted into the patient's body.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information. Its purpose is purely mechanical support and stabilization.
Therefore, based on the provided information, the Scient'x Spinal System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system 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 thoracic, lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, Fracture, Dislocation, Kyphosis, Spinal tumor, and Failed previous fusion (pseudoarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP
Device Description
The Scient'x Spinal System consists of monoaxial pedicle screws, rigid rods and crosslink members, semi-rigid rods, polyaxial screws, cross link and closed and open screws. It can be used for single or multiple level fixations. The modifications included in this submission is the addition of Polyaxial LP Screws, and additional sizes of Polyaxial TTL U Screws, Polyaxial TTL High U-screw, Monoaxial TTL U Screws, Polyaxial Hemispherical Screws, MX Polyaxial Screws, MX Monaxial Screws - Closed and MX Monaxial Screws - Open.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was undertaken to determine the mechanical properties of the pedicle screw systems. Testing was performed following the protocol of ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
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.
K051063, K013444, K990118, K990118, K043001, K042964, K062785
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.
0
Special 510(k) Summary for the Scient"x Spinal System
K062912
Page 1 of 1
This safety and effectiveness summary for the Scient'x Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
Date Prepared: January 9, 2007
-
- Submitter: Scient'x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE
Contact Person: J.D. Webb The OrthoMedix Group, I. c. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
- Submitter: Scient'x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE
FEB - 5 2007
- Trade name: Common Name: Classification Name:
Scient'x Spinal System posterior pedicle screw system Pedicle screw spinal system 21 CFR 888.3070 MNI/MNH
3. Predicate or legally marketed devices which are substantially equivalent:
- Scient'x previously cleared devices: .
- LTD Polyaxial Screw K062785 (US Spine) .
4. Description of the device:
The Scient'x Spinal System consists of monoaxial pedicle screws, rigid rods and crosslink members, semi-rigid rods, polyaxial screws, cross link and closed and open screws. It can be used for single or multiple level fixations. The modifications included in this submission is the addition of Polyaxial LP Screws, and additional sizes of Polyaxial TTL U Screws, Polyaxial TTL High U-screw, Monoaxial TTL U Screws, Polyaxial Hemispherical Screws, MX Polyaxial Screws, MX Monaxial Screws - Closed and MX Monaxial Screws - Open.
Materials:
Ti6Al4V alloy, conforming to ASTM F136 and ISO 5832-3
5. Intended Use:
The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system 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 thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, disfocation, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
The Scient'x pedicle screws included in this submission to previous Scient'x pedicle screws and a recently cleared US Spine screw. All have the same indications and material, and similar designs. Changes are confined to modification of screw diameter and/or polyaxial mechanism.
7. Summary of Nonclincal Tests
Testing was undertaken to determine the mechanical properties of the pedicle screw systems. Testing was performed following the protocol of ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEE - a 200
Scient'x c/o Mr. J.D. Webb The Orthomedix Group, Incorporated 1101 Oakwood Boulevard Round Rock, Texas 78681
K062912 Trade/Device Name: Scient'x Spinal System Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH, KWP, KWP, KWQ Dated: September 22, 2006 Received: September 27, 2006
Dear Mr. Webb:
Re:
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 beer 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 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.
2
Page 2 - Mr. J.D. Webb
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); 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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _ K0629/2
Device Name: __ Scient'x Spinal System_
Indications for Use:
The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system 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 thoracic, lumbar and sacral spine:
- Degenerative spondylolisthesis with objective evidence of neurological ♥ impairment,
- Fracture, .
- Dislocation, .
- Kyphosis,
- Spinal tumor, and
- Failed previous fusion (pseudoarthrosis).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chailare Borchurs fr. myy
(Division Sign)
storative. and Neurologacal Devices
510(k) Number K062912