(27 days)
No
The document describes a mechanical spinal fixation system made of stainless steel and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for spinal fixation for various spinal conditions, including degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, deformities, tumor, and failed fusion, which are all therapeutic interventions.
No
The document states that the Spiral Radius 90-D™ SST System is indicated for "spinal fixation" and provides indications for its use in various spinal conditions, such as "degenerative disc disease," "spondylolisthesis," "fracture," and "spinal stenosis." These describe the conditions the device is used to treat, not diagnose. It functions to stabilize, immobilize, or reconstruct the spine, which are treatment-oriented actions.
No
The device description explicitly states the components are made of medical grade stainless steel material, indicating a hardware-based device for spinal fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic or monitoring purposes.
- Device Description and Intended Use: The description and intended use clearly state that the Spiral Radius 90-D™ SST System is a system of components (rods, screws, hooks, crosslinks) made of medical grade stainless steel intended for spinal fixation and stabilization during surgical procedures. It is an implantable device used to physically support and stabilize the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens, provide diagnostic information based on laboratory tests, or being used outside of the body for diagnostic purposes.
Therefore, the Spiral Radius 90-D™ SST System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation.
When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spines. The points of attachment and methods are screw fixation to the anterolateral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc 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), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).
When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacraliliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).
When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.
In addition, when used as a pedicle screw system, in the noncervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Product codes
MNH, KWP, KWQ, MNI
Device Description
The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation. The material used is medical grade stainless steel material that conforms to ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar, thoracic, cervical spine, sacrum, ilium
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)
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.
0
Summary of Safety and Effectiveness IX.
United States Surgical SUBMITTER: A division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, CT 06856
Luis Nesprido CONTACT PERSON:
July 10, 2001 DATE PREPARED:
Spinal Intervertebral Body Fixation Orthosis CLASSIFICATION NAME: Spinal Interlaminal Fixation Orthosis Spondylolisthesis Spinal Fixation Device System
Stainless Steel Spinal Rod System COMMON NAME:
Spiral Radius 90-D™ SST System PROPRIETARY NAME:
USS's Spiral Radius 90-D™ System – K992784 & PREDICATE DEVICES: K000009 & the Rogozinski Spinal Rodding System -K954696
The components of the Spiral Radius 90-D™ SST System are INTENDED USE: indicated for spinal fixation.
When used as an anterolateral/anterior system consisting of rods ands screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The Indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the history and radiographic studies. confirmed ه disc spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).
When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).
When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, The Spiral Radius 90-D™ SST
1
System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.
In addition, when used as a pedicle screw system, in the noncervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
MATERIALS: The material used is medical grade stainless steel material that conforms to ASTM F138.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a bird in flight or a symbolic representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2001
Ms. Luis Nesprido Senior Associate, Regulatory Affairs United States Surgical A Division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, Connecticut 06856
Re: K012273
Trade Name: Spiral Radius 90-DTM SST System Frade Name: "Spiral Pass.3050, 888.3060, and 888.3070 Regulatory Class: II Product Code: MNH, KWP, KWQ, and MNI Dated: July 18, 2001 Received: July 19, 2001
Dear Ms. Nesprido:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section 3 rQxy nearstantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encrosure) to device Amendments, or to devices that have been reclassified in enacificin date of the Medical Doviet Faderal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of the general controls provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, Controls provisions of the rice network and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see associated to such additional controls. Existing major regulations (1 renarce rippival), it hay of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good A substantially equirement, as set forth in the Quality System Regulation (QS) for Martination ing Practice requiration (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drug realitines and in regulatory action. In addition, FDA may publish contiply with the Grill Teganation and our device in the Federal Register. Please note: this rurner almounteenting concerning your submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Luis Nesprido
This letter will allow you to begin marketing your device as described in your 110k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri Inding of successification 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 CER Part 801 and If you desire specific advice for your do real not be and the Office of Compliance at additionally 607.10 for m viro diagnestions on the promotion and advertising of your device, (201) 594-4037. Traditionally, for quese at (301) 594-4639. Also, please note the regulation
Please contact the Office of Compliance at (301) 594-4639. Also, please of Com prease connect the Office or Comphane as (301) Dotification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnees and its toll of 100 miles (800) 638-2041 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
AAMephullerm for
Justin M. White, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use V. 510(k) Number (if known):
Ko12273
Spiral Radius 90-D™ SST System Device Name:
Indications For Use:
The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation.
When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spines. The points of attachment and methods are screw fixation to the anterolateral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc 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), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).
When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacraliliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).
When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.
In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
(Please do not write below this line - continue on another page if needed)
| Prescription Use: | ✓ |
|---|---|
| Use: | |
| (Per 21 CFR 801.109) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K012273 |
|---|---|
| --------------- | --------- |