(272 days)
Not Found
No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML components.
Yes
The device is intended to provide stabilization to promote fusion for various conditions like degenerative disc disease, spondylolisthesis, and fractures, which are therapeutic interventions.
No
Explanation: The Synthes OC Fusion System is described as a system of implants (plates, screws, clamps, and rods) intended to provide stabilization and promote fusion of the occipital-cervical junction. Its purpose is mechanical support and stabilization, not to diagnose conditions.
No
The device description explicitly details physical components like occipital plates, screws, clamps, and rods, all made of metal. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Synthes OC Fusion System is a surgical implant designed to provide mechanical stabilization to the occipital-cervical junction. It is used in vivo (within the body) during surgery to promote bone fusion.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples or provide diagnostic information. Its function is purely structural and mechanical.
Therefore, the Synthes OC Fusion System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.
Synthes OC Fusion System is indicated for the following: DDD of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, atlanto/axial fracture with instability, occipital-cervical dislocation, revision of previous cervical spine surgery, and tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Synthes OC Fusion System consists of occipital plates, occipital screws, occipital clamps, and rods intended to provide stabilization to promote fusion of the occipital-cervical junction. This system allows an occipital-cervical construct of either the occipital plate and rods or occipital clamps and rods. Rods are connected to the occipital plate or occipital clamps using a locking screw. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.
The occipital bone screws are available in 4.5mm and 5.0mm diameters in lengths from 4mm to 18mm. Variable angle screw insertion is possible.
The occipital clamps are available in either a one-hole or two-hole configuration. The occipital plate is available in two sizes in either a medial or lateral configuration for a total of four available plates.
The plates are manufactured from commercially pure Titanium, grade 4. The rod connection points (rod clamps) in the plate are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the occipital clamps, rods, and occipital screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
occipital-cervical junction, occiput, cervical vertebrae
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)
Non-Clinical Performance and Conclusions: Bench testing results demonstrate that the Synthes OC Fusion System is substantially equivalent to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
K982322 - Synthes Occipital-Cervical Plate/Rod and Hook System, cleared November 25, 1998
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
§ 888.3050 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
K053418
Page 1 of 3
510(k) Summary
SEP -6 2006
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Susan Lewandowski |
| Manager, Spine Regulatory Affairs | |
| Telephone: 610-719-5712 | |
| Facsimile: 610-719-5102 | |
| Email: Lewandowski.susan@synthes.com | |
| Date Prepared: | August 28, 2006 |
| Trade Name: | Synthes OC Fusion System |
| Common Name: | Posterior, Cervical, Non-pedicle System |
| Classification: | 21 CFR 888.3050 Spinal Interlaminal Fixation Orthosis |
| Class II | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code KWP | |
| Predicate Device(s): | K982322 - Synthes Occipital-Cervical Plate/Rod and Hook |
| System, cleared November 25, 1998 |
:
・
1
| Device Description: | The Synthes OC Fusion System consists of occipital plates,
occipital screws, occipital clamps, and rods intended to provide
stabilization to promote fusion of the occipital-cervical junction.
This system allows an occipital-cervical construct of either the
occipital plate and rods or occipital clamps and rods. Rods are
connected to the occipital plate or occipital clamps using a
locking screw. A complete occipital-cervical-thoracic construct
can be created by using hooks (C1-T3) that have been previously
cleared within the Synthes CerviFix System and the Synthes Axon
System.
The occipital bone screws are available in 4.5mm and 5.0mm
diameters in lengths from 4mm to 18mm. Variable angle screw
insertion is possible.
The occipital clamps are available in either a one-hole or two-hole
configuration. The occipital plate is available in two sizes in
either a medial or lateral configuration for a total of four available
plates.
The plates are manufactured from commercially pure Titanium,
grade 4. The rod connection points (rod clamps) in the plate are
manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb)
as are the occipital clamps, rods, and occipital screws. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use: | Synthes OC Fusion System is intended to provide stabilization to
promote fusion of the occipital-cervical junction. A complete
occipital-cervical-thoracic construct can be created by using
hooks (C1-T3) that have been previously cleared within the
Synthes CerviFix System and the Synthes Axon System.
Synthes OC Fusion System is indicated for the following: DDD of
the cervical vertebrae (neck pain of discogenic origin with
degeneration of the disc as confirmed by patient history and
radiographic studies), spondylolisthesis, spinal stenosis,
atlanto/axial fracture with instability, occipital-cervical
dislocation, revision of previous cervical spine surgery, and
tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws
are not intended to be placed in the cervical spine. |
r
2
| Comparison of the
technological
characteristics of the
device to predicate
device(s): | The Synthes OC Fusion System is a result of design modifications
to the predicate devices. It is substantially equivalent to the
predicates in design, function, material and intended use. |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data
(Nonclinical and/or
Clinical): | Non-Clinical Performance and Conclusions:
Bench testing results demonstrate that the Synthes OC Fusion
System is substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
:
:
:
.
r
11 - 11 - 11
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1
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Synthes Spine c/o Ms. Susan Lewandowski 1302 Wrights Lane East West Chester, PA 19380
Re: K053418
Trade Name: Synthes OC Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP Dated: August 28, 2006 Received: August 31, 2006
Dear Ms. Lewandowski:
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 n your de rise 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.
4
Page 2 - Ms. Susan Lewandowski :
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be deviloed that I Dr o sation that your device complies with other requirements of the Act that I Dri has Intatutes 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 Of to rate 077) have 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. product racketing will allow you to begin marketing your device as described in your Section 510(k) rms leter watification. The FDA finding of substantial equivalence of your device to a legally promatics notifications on "cersults 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 other general managemal 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/industry/support/index.html.
Sincerely yours,
Barbara Inehm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number K053418
Synthes OC Fusion System Device Name:
Synthes OC Fusion System is intended to provide stabilization to promote Indications for Use: fusion of the occipital-cervical junction. A complete occipital-cervicalthoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.
Synthes OC Fusion System is indicated for the following:
- Degenerative disc disease of the cervical vertebrae (neck pain of . discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis .
- Fracture/Dislocation .
- . Atlanto/axial fracture with instability
- Occipital-cervical dislocation .
- Revision of previous cervical spine surgery .
- Tumors (primary and metastatic) .
The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) :
510(k) Number Kos 3418
Concurrence of CDRH, Office of Device Evaluation (ODE)
| K053418 | Barbara Buehler |
|---|---|
| (Division Sign-Off) | for MKM |
Division of General, Restorative,
and Neurological DevicesENTIAL
CONFIDENTIAL Synthes OC Fusion System
Page 1 of 1 Traditional 510(k)