(30 days)
Not Found
Not Found
No
The provided text describes a spinal implant system (connectors) and its intended use. There is no mention of any software, algorithms, or capabilities that would suggest the use of AI or ML. The description focuses solely on the physical components and their application in spinal fusion procedures.
Yes
The device is indicated for conditions such as degenerative disk disease, spondylolisthesis, fracture, spinal stenosis, deformities, and tumors, with the explicit goal of providing stabilization and immobilization of spinal segments as an adjunct to fusion. These are therapeutic interventions aimed at treating medical conditions.
No
The "Intended Use / Indications for Use" section describes the conditions for which the SCS system is indicated, all of which are diagnoses. The "Device Description" states that the device is a connector used to connect rods and screws of a spinal system. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description explicitly states "The SCS Claris Spinal Lengthened Lateral Connectors are available in one size only and are used to connect the rods and screws of the SCS Claris Spinal System." This describes a physical hardware component, not software.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly indicate that this device is a surgical implant (spinal system components) used to provide immobilization and stabilization of spinal segments in patients. It is a physical device implanted in the body, not a test performed on a sample outside the body.
The information provided describes a medical device used in surgery, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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 by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).
When used as an anterolateral/anterior 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, failed previous fusion (pseudarthrosis).
When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and 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. Screw fixation is limited to L3 and below.
Posterior pedicle systems are 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP, KWQ
Device Description
The SCS Claris Spinal Lengthened Lateral Connectors are available in one size only and are used to connect the rods and screws of the SCS Claris Spinal System.
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 joint, L3 and below
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)
Not Found
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.
Not Found
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
510(k) SUMMARY of Safety and Effectiveness
| Sponsor: | OrthoTec, LLC
9595 Wilshire Blvd. Suite 502
Beverly Hills, CA 90212
Phone: (310) 557-2000 & (310) 273-1500
Fax: (310) 843-9500 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Patrick Bertranou, MD |
| Proprietary
Trade Name: | SCS Claris Lengthened Lateral Connector (AL06) |
| Device
Description: | The SCS Claris Spinal Lengthened Lateral Connectors are available in one size
only and are used to connect the rods and screws of the SCS Claris Spinal
System. |
| Intended Use: | 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 by history and radiographic
studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis,
kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).
When used as an anterolateral/anterior 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, failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the SCS system is indicated for use
in skeletally mature patients L3 and 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. Screw fixation is limited to L3 and below.
Posterior pedicle systems are 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: degenerative
spondylolisthesis with objective evidence of neurologic impairment, fracture,
dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion
(pseudarthrosis). |
| Materials: | The SCS Claris Spinal System Lengthened Lateral Connector (AL06) is
manufactured from stainless steel (ASTM F136 / ISO 5832-1) and titanium alloy
(ASTM F138 / ISO 5832-3). |
| Substantial
Equivalence: | Documentation was provided which demonstrated the SCS Claris Lengthened
Lateral Connector (AL06) to be substantially equivalent to the previously
cleared SCS Extremity Connector (AL02). The substantial equivalence is based
upon equivalence in indications/intended use, manufacturing methods,
interconnection (attachment) mechanism, basic design and materials. |
Page 47
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2002
OrthoTec. LLC c/o Ms. Karen Warden, MEBE 8202 Sherman Road Cleveland, Ohio 44026-2141
Re: K021379
Trade Name: SCS Claris Spinal System Lengthened Lateral Connector (AL06) Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 and 21 CFR 888.3060 Regulatory Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis and Spinal intervertebral body fixation orthosis
Regulatory Class: II Product Code: MNI, MNH, KWP, KWQ Dated: April 26, 2002 Received: May 1, 2002
Dear Ms. Warden:
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 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.
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.
2
Page 2 - Patrick Bertranou, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) - rms reter with and it your finding of substantial equivalence of your device to a legally promation in a classification for your device and thus, permits 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Compliance at (201) 57 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entral information on your responsibilities under the Act may be obtained from the O insi gonetar in in an and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milham
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K (02 | 379
Device Name: SCS Claris Spinal System
Indications for Use:
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 by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, fordosis) tumors failed previous fusion (pseudarthrosis)
When used as an anterolateral/anterior 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 failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients 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. screw fixation is limited to L3 and below.
Posterior pedicle systems are 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:
degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Mark N Mellem
Division Sign-Off
ision of General. Restorative
510(k) Number
Confidential: OrthoTec - SCS Claris Lengthened Lateral Connector (AL06) Modification
Page 22