(64 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a 'spinal fixation system' intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal instabilities or deformities, clearly indicating a therapeutic purpose.
No
The device is described as a "temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion." Its intended use and indications for use clearly describe it as a fixation system for treatment of spinal instabilities and deformities, not for diagnosing them.
No
The device description explicitly states it is a "temporary implant system" consisting of physical components like screws, rods, and hooks made from titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, 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: The Silhouette™ Spinal Fixation System is described as a "temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion." It consists of physical components like screws, rods, and hooks that are surgically implanted into the spine.
- Intended Use: The intended use clearly states that the system is used for "immobilization and stabilization of spinal segments as an adjunct to fusion" in the treatment of various spinal conditions. This involves physical intervention and support of the spine, not the analysis of biological samples.
The device is a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization of spinal segments 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, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:
- having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint a)
- who are receiving fusions with autogenous graft only b)
- who are having the device fixed or attached to the lumbar or sacral spinc, and c)
- d) who are having the device removed after the development of a solid fusion mass
When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
Product codes
KWP, MNH, MNI
Device Description
The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, T1 to the sacrum
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
Fatigue Testing of Silhouette™ Spinal Fixation System/adjustable transverse connector construct per ASTM Provisional Standard PS 5-94, Test Method for Static and Dynamic Spinal Implant Assembly in a Corpectomy Model. Acceptance Criteria: No Failures 156 N run-out load 5,000,000 cycles. Test Results: Passed.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/3 description: The image shows the words "SULZER MEDICA" in a bold, sans-serif font. The text is black and appears to be a logo or brand name. The words are arranged horizontally, with "SULZER" above "MEDICA".
NOV 1 6 1999
1.493067
Sulzer Spine-Tech
7375 Bush Lake Road Minneapolis, MN 55439-2027
Phone 612-832-5600 612-832-5620 Fax
510(k) Summary
| A. | Submitters' Information | |
|---|---|---|
| Date: | November 15, 1999 | |
| Name/Address: | Sulzer Spine-Tech | |
| 7375 Bush Lake Road | ||
| Minneapolis, Minnesota 55439 | ||
| Telephone Number: | ||
| Fax Number: | (612) 830-6205 | |
| (612) 832-5620 | ||
| Contact: | Janell A. Colley | |
| Regulatory Affairs Specialist | ||
| B. | Device Information | |
| Trade Name: | Silhouette™ Spinal Fixation System | |
| Common Name: | Rod, hook, and screw spinal | |
| instrumentation | ||
| Classification: | Class II, KWP, MNI, and MNH | |
| Predicate Device: | Silhouette™ Spinal Fixation System | |
| K992276 | ||
| (concurrence date October 1, 1999) |
Device Description:
The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.
1
Intended Use:
When used as a pedicle screw fixation system in skeletally mature patients, the 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 or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:
- having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 ೩) joint
- who are receiving fusions with autogenous graft only b)
- who are having the device fixed or attached to the lumbar or c) sacral spine, and
- d) who are having the device removed after the development of a solid fusion mass
When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
2
C. Comparison of Required Technological Characteristics
The modified Silhouette™ Spinal Fixation System is substantially equivalent to the predicate Silhouette™ Spinal Fixation System. The table below provides a comparison of equivalency characteristics.
| Characteristics | Equivalency |
|---|---|
| Intended Use | Identical |
| Anatomical Sites | Identical |
| Target Population | Identical |
| Sterilization | Identical |
| Packaging | Identical |
| Operating Principle | Identical |
| Materials | Identical |
| Labeling | Substantially Equivalent |
| Physical Characteristics (Design) | Substantially Equivalent |
| Performance Testing | Substantially Equivalent |
| Safety Characteristics | Substantially Equivalent |
D. Summary of Non-Clinical Tests
The following is a summary of the testing performed on the modified Silhouette™ Spinal Fixation System:
| Modification | Test Performed | Acceptance
Criteria | Test Results |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------|
| Addition of
Adjustable
Transverse
Connector | Fatigue Testing of Silhouette™
Spinal Fixation
System/adjustable transverse
connector construct per ASTM
Provisional Standard PS 5-94,
Test Method for Static and
Dynamic Spinal Implant
Assembly in a Corpectomy
Model | No Failures
156 N run-out
load
5,000,000 cycles | Passed |
Conclusions Drawn From Testing E.
Testing of the modified Silhouette™ Spinal Fixation System demonstrates that the device is substantially equivalent to the predicate Silhouette™ Spinal Fixation System and that the design modifications do not affect device safety and effectiveness
3
Image /page/3/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 symbol, with three curved lines representing its body and wings. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Ms. Janell A. Colley Regulatory Affairs Specialist Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027
Re: K993067
Trade Name: Silhouette™ Spinal Fixation System Regulatory Class: II Product Codes: KWP, MNH and MNI Dated: October 21, 1999 Received: October 22, 1999
Dear Ms. Colley:
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 Ouality 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 Federal laws or regulations.
4
Page 2 - Ms. Janell A. Colley
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(K) Number: K993067
Silhouette™ Spinal Fixation System Device Name:
Indications for Use:
When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization of spinal segments 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, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:
- having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint a)
- who are receiving fusions with autogenous graft only b)
- who are having the device fixed or attached to the lumbar or sacral spinc, and c)
- d) who are having the device removed after the development of a solid fusion mass
When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
AR colep B
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993067
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter-Use