(168 days)
Not Found
No
The description focuses on the mechanical design and material of a vertebral body replacement device, with no mention of AI or ML capabilities.
Yes
The device replaces a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve decompression of the spinal cord and neural tissues and restore height, which are therapeutic actions.
No
The device is a vertebral body replacement device, intended for surgical implantation to treat spinal conditions like tumors or trauma, not to diagnose them.
No
The device description clearly states the GraftCage TLX is made from implantable PEEK polymer and is a physical device designed to replace a vertebral body. It also describes a physical insertion tool.
Based on the provided information, the GraftCage™ TLX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- GraftCage TLX Function: The GraftCage TLX is a surgical implant designed to replace a damaged vertebral body in the spine. It is a physical device that is surgically inserted into the patient's body.
- Intended Use: The intended use clearly states it is a "vertebral body replacement device" for surgical implantation to restore spinal height and provide support.
- Device Description: The description details the physical characteristics and material of the implant, not a device for analyzing biological samples.
Therefore, the GraftCage TLX falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The GraftCage™ TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (T1-L5). The GraftCage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.
The GraftCage TLX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage TLX is optional.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The GraftCage TLX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in cases of spinal trauma/fracture. The GraftCage TLX is made from implantable PEEK (polyetheretherketone) polymer.
The GraftCage TLX is rectangular -to- oval in shape, with its anterior aspect slightly convex and posterior aspect slight concave. One central (axial) fenestration and two fenestrations on each anterior and posterior aspect provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and /or migration after implantation. The device is nonlordotic (0°) i.e., parallel. The lateral aspects are tapered, or bulleted, for ease of insertion.
Two threaded holes, one at each lateral aspect, interface with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches both threaded holes on the GraftCage TLX and allows the surgeon to hold the GraftCage TLX while implanting it into the patient. Each threaded hole is at a different angle relative to the long axis of the implant. The different angles allow the surgeon to choose the best surgical approach depending upon the specific clinical situation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic or lumbar 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)
Not Found
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.
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
§ 888.3060 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
KOS 1781
1 2
DEC 16 2005 510(k) Summary GraftCage™ TLX
| Submitted by | Address | Telephone | Contact Person |
|---|---|---|---|
| Osteotech, Inc. | 51 James Way | ||
| Eatontown, New Jersey | |||
| 07724 | (800) 537-9842 | ||
| x 6324 | Christopher Talbot | ||
| Dir. Regulatory Affairs | |||
| DATE June 20, 2005 | Subject Device | Predicate Devices | |
| Trade Name | GraftCage TLX | • Synthes Spine's Vertebral Spacer-TR, | |
| K011037, cleared July 1, 2002; | |||
| • Interpore Cross's GEO Structure, | |||
| K010530, cleared August 3, 2001; and | |||
| • Stryker Spine's AVS TL Spacer, | |||
| K042571 cleared February 11, 2005. | |||
| Common Name | Vertebral Body Replacement Device | ||
| Classification Name | Spinal Intervertebral Body Fixation Orthosis |
Device Description:
The GraftCage TLX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in cases of spinal trauma/fracture. The GraftCage TLX is made from implantable PEEK (polyetheretherketone) polymer.
The GraftCage TLX is rectangular -to- oval in shape, with its anterior aspect slightly convex and posterior aspect slight concave. One central (axial) fenestration and two fenestrations on each anterior and posterior aspect provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and /or migration after implantation. The device is nonlordotic (0°) i.e., parallel. The lateral aspects are tapered, or bulleted, for ease of insertion.
Two threaded holes, one at each lateral aspect, interface with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches both threaded holes on the GraftCage TLX and allows the surgeon to hold the GraftCage TLX while implanting it into the patient. Each threaded hole is at a different angle relative to the long axis of the implant. The different angles allow the surgeon to choose the best surgical approach depending upon the specific clinical situation.
Intended Use:
The GraftCage™ TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (T1-L5). The GraftCage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.
The GraftCage TLX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage TLX is optional.
1
510(k) Summary GraftCage TLX Osteotech, Inc.
Comparison to Predicate:
The GraftCage TLX claims substantial equivalence to:
- Synthes Spine's Vertebral Spacer-TR, K011037, cleared July 1, 2002;
-
- Synthes Spine 3 V GEO Structure, K010530 cleared August 3, 2001; and
-
- Stryker Spine's AVS TL Spacer, K042571 cleared February 11, 2005.
This claim of substantial equivalence is intended to reflect FDA's definition of substantial equivalence as defined by 21 CFR Part 807, Subpart E and is not intended to reflect a claim of substantial equivalence in terms of intellectual property.
The GraftCage TLX and the predicate devices have the same intended use and similar technological The GraftCage TLX and the produced deverates that the GraftCage TLX meets or exceeds functional requirements for a vertebral body replacement device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three figures in profile, representing health and human services.
Public Health Service
DEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher Talbot Director, Regulatory Affairs Osteotech Incorporated 51 James Way Eatontown, New Jersey 07724
Re: K051781
Trade Name: GraftCage™ TLX VBR System Trade Name: Sierrer: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 8, 2005 Received: December 9, 2005
Dear Mr. Talbot:
We have reviewed your Section 510(k) premarket notification of intent to maket the device referenced We have reviewed your Section 10(c) prematically equivalent (for the indications for use stated in the above and have devels is device is substantially to the normance prior to May 28, 1976,
enclosure) to legally marketed in interstate on interste commerce prior to May 28, 197 enclosure) to legally marketed predicate devices markets, or to devices that have been reclassified in
the enactment date of the Medical Device Amendments, or to devices that the enactment date of the Medicel Device Amending of to device the for that do not require
accordance with the provisions of the Federal Food, Drug, and Cosmetice, market the accordance with the provisions of the Federal Production, make the device, subject to
approval of a premarket approval application (PMA). You may, the Act include approval of a provisions of the Act. The general controls provisions of the Act include
the general controls provisions of the Act. The general controls provisions of the Ac the general controls provisions of the Act. I ne gelievis provises, good manufacturing practice, labeling, and
requirements for annual registration, listing of devices, good requirements for annual varies and adulteration.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be found in the If your device is classified (see above) into either class ut (Special Conne very of the vise can be found in the subject to such additional controls. Extraig major regalitions atiooning
Code of Federal Regulations, Title 2 i, Parts 80 to 898. In addition, FDA may publish further
Cod Code of Federal Regulations, The Vice in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that Please be advised that FDA 's issuance of a substantal equirements of the Act or any
FDA has made a determination that your device comples with ather requirements of the all FDA has made a determination that your device compites You must comply with all the Federal statutes and regulations administed or registration and listing (21 CFR Part 807); abeling (21
Act's requirements, including, but not limite are wirements as set fort Act's requirements, including, but not himied to ricense as set forth in the quality systems (QS)
CFR Part 801); good manufacturing practice requirements as set forth in the CFR Part 801); good manufacturing practice requirents as set rother from the provisions
regulation (21 CFR Part 820); and if applicable, the electronic product radiation cont (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Christopher Talbot
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket I his letter will allow you to begin marketing your device to a legally market predicate notification. The FDA Inding of substancial equivals. So 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 (1) idease contact (1) idease contact (1) idease contact (1) idease If you desire specific advice for your de 160 en barness and e the regulation entitled, "Misbranding by the Office of Compliance at (240) 276 0126. Thiss) press are may obtain other general information on reference to premiation (21 ct readon' (21 ct read Manufacturers, International and your responsibilities under the Rection the Drivision of Call or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson.
Acting 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 (IF KNOWN): K OS 1 7 81
DEVICE NAME: GraftCage TLX
INDICATIONS FOR USE:
The GraftCage™ TLX is a vertebral body replacement device intended to replace a The Grantcage - TEA Is a vertebral body in the thoracic or lumbar spine (TI-L5). conapsed, uainaged, or unsacted for a partial or total vertebrectomy for cases of tumor or The Grancage TLX is marcated for a particage TLX is intended to achieve anterior decompression trauma (f.c., fractare). "The Crasveal and to restore the height of a collapsed vertebral body.
The GraftCage TLX is intended for use with supplemental internal spinal fixation The Grancage TEA is meended for use in the thoracic and lumbar spine. These systems Systems that are created of rear and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the GraftCage TLX is optional.
Prescription Use_V (Per 21 CFR 801.109) OR
Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________
X_____________________________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
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)
| (Division Sign-Off) |
|---|
| Division of General, Restorative, |
| and Neurological Devices |
| 510(k) Number | K051781 |
|---|---|
| --------------- | --------- |