(76 days)
Not Found
No
The summary describes a mechanical implant and associated instrumentation, with no mention of AI/ML capabilities or data processing.
Yes
The device is intended to treat a pathological condition (tumor or trauma) by replacing a vertebral body and providing anterior spinal column support.
No
The device is a vertebral body replacement device, intended for structural support after corpectomy or vertebrectomy, not for diagnosing medical conditions.
No
The device description clearly states it is a titanium vertebral body replacement device and includes manual surgical instrumentation, indicating it is a physical hardware device.
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 provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Vertebral Spacer Ti is a vertebral body replacement device intended for surgical implantation in the spine to provide structural support. It is a physical implant, not a device used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, the Vertebral Spacer Ti falls under the category of a surgical implant or a structural medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Vertebral Spacer Ti 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 Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the 7i Spacer System can be packed with bone. The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Product codes
MQP
Device Description
The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of: vertebral body replacement devices comprised of a variety of fixed heights and cross-sections.supplemental fixation currently cleared for use in treating patients for tumor, trauma or fractures of the vertebral body andmanual surgical instrumentation used to prepare the anatomy and implant the Vertebral Spacer Ti.There are no unique surgical instruments required for implantation of the submitted device system. All components of the Vertebral Spacer Ti are manufactured from commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295).
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
skeletally mature individuals
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 Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 was presented.
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
§ 888.3060 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
Ko 2456 Premarket Notification - Vertebral Spacer Ti
Summary of Safety and Effectiveness Information 3.0
| SPONSOR: | MAR 1 7 2003
Synthes Spine Company, L. P.
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Jonathan Gilbert |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes Vertebral Spacer Ti |
| CLASSIFICATION: | Per CFR 21, §888.3060: Implant, fixation, spinal intervertebral
body fixation orthosis devices. Class II.
Product code is MQP. The Panel code is 87. |
| PREDICATE DEVICE: | Vertebral body replacement device:
Synthes Vertebral Spacer, Ti: K020152
SE date: April 16, 2002. |
| DEVICE
DESCRIPTION: | The Vertebral Spacer Ti is a titanium vertebral body
replacement device used in conjunction with supplemental
internal fixation to provide structural stability in skeletally
mature individuals following corpectomy or vertebrectomy and
consists of:
vertebral body replacement devices comprised of a variety
of fixed heights and cross-sections.supplemental fixation currently cleared for use in treating
patients for tumor, trauma or fractures of the vertebral body
andmanual surgical instrumentation used to prepare the
anatomy and implant the Vertebral Spacer Ti.There are no unique surgical instruments required for
implantation of the submitted device system. |
| INTENDED USE: | The Vertebral Spacer Ti 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 Vertebral Spacer Ti System is
intended to be used with Synthes supplemental internal fixation
systems, e.g., ATLP, VentroFix, USS and Small Stature USS.
The interior of the spacer component of the Vertebral Spacer Ti
can be packed with bone.
The Vertebral Spacer Ti is designed to provide anterior spinal
column support even in the absence of fusion for a prolonged
period. |
1
All components of the Vertebral Spacer Ti are manufactured MATERIAL: from commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295).
Mechanical testing in accordance with the "Guidance for PERFORMANCE Industry and FDA Staff, Guidance for Spinal System 510(k)s", DATA: September 27, 2000 was presented.
The Vertebral Spacer Ti implants are similar to the predicate BASIS OF Synthes Vertebral Spacer Ti body replacement device(s), SUBSTANTIAL (K020152) with respect to technical characteristics and EQUIVALENCE: performance. The supplemental fixation devices intended for use with the Vertebral Spacer Ti implants are currently cleared for use in patients with either tumor, trauma or fractures.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2003
Mr. Jonathan Gilbert RA Project Manager Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
Re: K024364
Trade/Device Name: Synthes Vertebral Spacer Ti Regulatory Number: 21, CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 30, 2002 Received: December 31, 2002
Dear Mr. Gilbert:
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
3
Page 2 - Mr. Jonathan Gilbert
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours,
Mark M. Millenn
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
Page 1 of 1
2.0 Indications for Use Statement
510(k) Number (if known):
Synthes Vertebral Spacer Ti Device Name:
Indications:
The Vertebral Spacer Ti 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 Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the 7i Spacer System can be packed with bone.
The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
for Mark N. Milliken
Division Sign-Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
024364 510(k) Number_
Synthes Spine Company, L. P. Vertebral Spacer Ti 510(k)