(46 days)
No
The document describes a mechanical implant for spinal support and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a vertebral body replacement, and its intended use is to replace a collapsed or unstable vertebral body due to tumor or trauma to provide anterior spinal column support. These functions address a medical condition by restoring anatomical structure and support, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a vertebral body replacement implant designed to provide structural support to the spine, not to diagnose medical conditions.
No
The device description clearly details a physical implantable device made of a hollow central body, telescoping end pieces, a locking ring, and endplates with teeth and spikes. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Synex™ II implant is a physical device intended to be surgically implanted into the thoracolumbar spine to replace a damaged vertebral body. It is a structural support device, not a device that analyzes biological samples.
The description clearly indicates it's a surgical implant for structural support in the spine.
N/A
Intended Use / Indications for Use
The Synex II Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synex II device is intended to be used with Synthes supplemental internal fixation systems, e.g., TSLP, Pangea, or USS.
The Synex II Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period of time.
Product codes
MQP
Device Description
The Synex II Spacer is a height expanding vertebral body replacement device consisting of a hollow central body and two endplates. The cylindrical body is comprised of two telescoping end pieces and a locking ring. The walls of the hollow cylindrical body have a plurality of holes intended for the placement of grafting materials to help achieve a solid fusion. Endplates are available in three footprint sizes. Each endplate is angled, has a plurality of holes and is designed with pyramidal teeth and small spikes to grip the adjacent vertebra.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1- L5)
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 in accordance with the "Guidance for Spinal System 510(k)s", issued May 3, 2004, was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
K061891 pg 1 of 2
5.0 510(K) Summary
.
AUG 1 8 2006
·
| Name of Firm | Synthes Spine Co. L.P.
1302 Wrights Lane East
West Chester, PA 19380 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Bonnie J. Smith |
| Device Trade Name | Synex ™ II |
| Common/Classification Name | Spinal intervertebral body fixation device |
| Panel/Product Code and Classification | Panel Code 87
Product Code MQP
21 CFR 888.3060: Class II |
| Predicate Device | K003836 - Synex ™ Spacer |
| Device Description | The Synex II Spacer is a height expanding vertebral
body replacement device consisting of a hollow central
body and two endplates. The cylindrical body is
comprised of two telescoping end pieces and a locking
ring. The walls of the hollow cylindrical body have a
plurality of holes intended for the placement of grafting
materials to help achieve a solid fusion. Endplates are
available in three footprint sizes. Each endplate is
angled, has a plurality of holes and is designed with
pyramidal teeth and small spikes to grip the adjacent
vertebra. |
| Indications for Use | The Synex II Spacer is a vertebral body replacement
device intended for use in the thoracolumbar spine (T1-
L5) to replace a collapsed, damaged, or unstable
vertebral body due to tumor or trauma (i.e., fracture).
The Synex II device is intended to be used with
Synthes supplemental internal fixation systems, e.g.,
TSLP, Pangea, or USS.
The Synex II Spacer is designed to provide anterior
spinal column support even in the absence of fusion for
a prolonged period of time. |
CONFIDENTIAL
1
K044891 pg 2 of 2
5.0 510(K) Summary (continued)
| Substantial Equivalence | The Synthes Synex II Spacer implants are similar to
the components of previously cleared spinal systems,
Synthes Synex, K003836, and DePuy Stackable Cage
System, K001340. The supplement fixation devices
for use with the Synex II are cleared for use in
patients with tumor, trauma or fractures. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | All components of the Synex II Spacer are
manufactured from titanium alloy, Ti6A17Nb (ASTM
F 1295). |
| Performance Data | Mechanical testing in accordance with the "Guidance
for Spinal System 510(k)s", issued May 3, 2004, was
presented. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
Synthes Spine Co. L.P. % Ms. Bonnie J. Smith Regulatory Affairs Project Manager 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K061891
Trade/Device Name: SYNEX™ II Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Vertebral Body Replacement Device Regulatory Class: Class II Product Code: MQP Dated: June 30, 2006 Received: July 3, 2006
Dear Ms. Smith:
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.
3
Page 2 – Ms. Bonnie J. Smith
This letter will allow you to begin marketing your device as described in your Section 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), 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement
510(k) Number: K061891
Device Name: SYNEX™ II Spacer
The Synex™ II implant is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synex II device is intended to be used with Synthes supplemental internal fixation systems, e.g., TSLP, Pangea and USS.
The Synex II device is designed to provide anterior spinal column support, even in the absence of fusion, for a prolonged period.
Prescription Use X (21 CFR 801.109 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chabara buchens for MXM
Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number