(77 days)
ISOLA, TSRH
KWP, MNI, MNH
No
The description focuses solely on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
This device is a therapeutic device because its intended use is to aid in the surgical correction of various spinal deformities and pathologies by providing stabilization during the development of fusion.
No
The device is described as a "posterior spinal fixation device" and a "spinal fixation system" used to aid in surgical correction and provide stabilization during fusion. Its purpose is mechanical support, not diagnosis.
No
The device description explicitly states it is comprised of physical components like bone screws, hooks, rods, and connectors that are implanted surgically. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SSCS is a "posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies." This describes a surgical implant used to stabilize the spine, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical components of the system (screws, hooks, rods, connectors) which are all designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), providing diagnostic information, or any of the typical functions of an IVD.
- Performance Studies: The performance studies focus on mechanical testing of the device's strength and stiffness, which is relevant for a surgical implant, not an IVD.
In summary, the SSCS is a surgical implant designed for mechanical stabilization of the spine, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Segmental Spinal Correction System (SSCS) is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracic-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the SSCS are dependent in part on the configuration of the assembled device as described below.
When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; previously failed attempts at spinal fusion.
When used as a pedicle screw system in the thoracolumbosacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw system, the SSCS is intended for patients:
-
- Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint
-
- Who are receiving fusions using autogenous bone graft only.
-
- Who are having the device fixed or attached to the lumbar and sacral spine (level of attachment: L3 and below).
-
- Who are having the device removed after the development of a solid fusion mass.
Product codes
KWP, MNI, MNH
Device Description
The SSCS (Segmental Spinal Correction System) is a spinal fixation system comprised of various types and sizes of components, that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems. the SSCS is comprised basically of 1) bone screws and hooks for attachment of the device to the spine, 2) longitudinal rods that are attached to the bone screws and hooks either directly or indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic-lumbo-sacral portion of the spine, T1 to S2, thoracolumbosacral region of the spine, L5-S1 vertebral joint, L3 and below
Indicated Patient Age Range
Not Found
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)
Mechanical testing of SSCS constructs was performed in accordance with the ASTM Standard for testing spinal implant devices. The test results demonstrated that the mechanical performance characteristics (bending-compression static strength and stiffness, torsional stiffness and fatigue strength) of SSCS constructs are at least comparable to, if not better than, those of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SSCS, ISOLA, TSRH
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
VIII. 510(k) Summary of Safety and Effectiveness
-
- Submission Applicant & Correspondent:
Name: Address:
- Submission Applicant & Correspondent:
Phone No .: Contact Person:
Osteotech, Inc. 51 James Way Eatontown, NJ 07724 (732) 542-2800 Christopher Talbot
Date of Summary:
May 6, 1999
-
- Name of Device:
SSCS (Segmental Spinal Trade/Proprietary/Model Name: Correction System)
- Name of Device:
Common or Usual Name:
Classification Name:
Spinal Interlaminal Fixation Orthosis; Spondylolisthesis Spinal Fixation Device System; Pedicle Screw Fixation System
Posterior Spinal Fixation Device
- Devices to Which New Device is Substantially Equivalent:
The SSCS is substantially equivalent, for the purpose of this 510(k) adding indications, to the following predicate devices.
| Trade/Proprietary/Model Name | Manufacturer |
|---|---|
| SSCS | Heinrich C. Ulrich |
| ISOLA | AcroMed |
| TSRH | Sofamor-Danek |
- Device Description:
The SSCS (Segmental Spinal Correction System) is a spinal fixation system comprised of various types and sizes of components, that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems. the SSCS is comprised basically of 1) bone screws and hooks for attachment of the device to the spine, 2) longitudinal rods that are attached to the bone screws and hooks either directly or indirectly by means of lateral connectors, and that transmit loads across the pathologic
1
segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.
5. Intended Use/Indications
The Segmental Spinal Correction System (SSCS) is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracic-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the SSCS are dependent in part on the configuration of the assembled device as described below.
When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; previously failed attempts at spinal fusion.
When used as a pedicle screw system in the thoracolumbosacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw system, the SSCS is intended for patients:
-
- Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint
-
- Who are receiving fusions using autogenous bone graft only.
-
- Who are having the device fixed or attached to the lumbar and sacral spine (level of attachment: L3 and below).
-
- Who are having the device removed after the development of a solid fusion mass.
6. Performance Data
Mechanical testing of SSCS constructs was performed in accordance with the ASTM Standard for testing spinal implant devices. The test results demonstrated that the mechanical performance characteristics (bending-compression static strength and stiffness, torsional stiffness and fatigue strength) of SSCS constructs are at least comparable to, if not better than, those of the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 1999
Mr. Christopher W. Talbot Director of Regulatory Affairs Osteotech, Inc. 51 James Way Eatontown, New Jersey 07724
Re: K991586
Trade Name: Segmental Spinal Correction System Regulatory Class: II Product Code: KWP, MNI and MNH Dated: May 6, 1999 Received: May 7, 1999
Dear Mr. Talbot:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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
3
Page 2 -- Mr. Christopher W. Talbot
Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Keith Wilson, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
I. Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: SSCS (Segmental Spinal Correction System)
Indications for Use:
The SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows:
-
- When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; and previously failed attempts at spinal fusion.
-
- When used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
-
- In addition, when used as a pedicle screw system, the SSCS is intended for patients:
- a. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (level of attachment: L3 and below).
- d. Who are having the device removed after the development of a solid fusion mass.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device, Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991586 |
Prescription Use >> (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)