(312 days)
Not Found
No
The device description focuses on mechanical components and surgical procedures, with no mention of AI/ML capabilities or data processing.
Yes
The device is intended to treat a damaged or unstable vertebral body due to tumor or trauma, which is a therapeutic purpose.
No
This device is a vertebral body replacement implant used to bridge defects and replace damaged vertebral bodies, not to diagnose conditions.
No
The device description clearly details a physical implant made of titanium alloy with mechanical components for height adjustment and fixation. There is no mention of software as a component or the primary function of the device.
No, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a "Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma." This is a surgical implant used within the body to provide structural support.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
This device is a surgical implant used for structural support in the spine, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obeliscTM Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bour grafting material with the obeliscTM Vertebral Body Replacement is optional.
Product codes
MQP
Device Description
The obelise TM Vertebral Body Replacement device is used for the bridging of substance defects in the anterior human thoracic and lumbar spine.
The defect is bridged by distraction of the implant and the vertebral column is straightened. Via a bevel gear drive unit, the necessary height of the implant can be adjusted exactly and fixed in situ. The height can be adjusted via a bevel gear drive unit, with pins to prevent overdistraction. The adjusted height is fixed in position by means of a locking screw. Spikes at the end pieces improve the anchoring of the implant on the end plates of the vertebral bodies.
Bone graft material can be placed around the obelise™ Vertebral Body Replacement as needed.
The obelisc ™ Vertebral Body Replacement consists of a center piece and two corresponding straight or angled end pieces. The standard diameter of the center pieces is 20 mm. One end has already been produced with a 0° end piece with Ø 20 mm. The end pieces are available in three diameters (20 mm, 26 mm) and with different angles (0°, 5°, 10°). One oval end piece (26 x 30 mm) with an angle of 15° is available. The center piece defines the minimum and maximum expansion height. The distraction heights range from 20 to 132 mm.
The implant components of this system are made from alloyed titanium according to ISO 5832-3:2000 and ASTM F-136-02a.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic and lumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open surgical procedures
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 was performed in accordance with ASTM F 2077 - 00 (Test Methods for Intervertebral Body Fusion Devices).
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
K060416
Page 1 of 3
Section 5 - 510(k) Summary
Submitter Information
Contact Christoph Ulrich Marketing Director Spinal Systems Management Representative for Quality Systems ulrich GmbH & Co. KG Buchbrunnenweg 12 89081 Ulm Germany
Telefon/Phone: +49 (0)731 9654-163 +49 (0)731 9654-2702 Telefax/Fax: e-mail: c.ulrich@ulrichmedical.com internet: http://www.ulrichmedical.com
Date Prepared October 31, 2006
Product Name obelisc™ Vertebral Body Replacement
Predicate Device
This device is substantially equivalent to the following legally marketed devices:
| 510(k) Reference | Description | Submitted By |
|---|---|---|
| K050850 | XPAND Corpectomy | |
| Spacer | Globus Medical, Inc. | |
| K012254 | VBR™ Vertebral Body | |
| Replacement Device | Osteotech, Inc. |
Product Description
The obelise TM Vertebral Body Replacement device is used for the bridging of substance defects in the anterior human thoracic and lumbar spine.
The defect is bridged by distraction of the implant and the vertebral column is straightened. Via a bevel gear drive unit, the necessary height of the implant can be adjusted exactly and fixed in situ. The height can be adjusted via a bevel gear drive unit, with pins to prevent overdistraction. The adjusted height is fixed in position by means of a locking screw. Spikes at the end pieces improve the anchoring of the implant on the end plates of the vertebral bodies.
DEC 26 2006
1
Bone graft material can be placed around the obelise™ Vertebral Body Replacement as needed.
The obelisc ™ Vertebral Body Replacement consists of a center piece and two corresponding straight or angled end pieces. The standard diameter of the center pieces is 20 mm. One end has already been produced with a 0° end piece with Ø 20 mm. The end pieces are available in three diameters (20 mm, 26 mm) and with different angles (0°, 5°, 10°). One oval end piece (26 x 30 mm) with an angle of 15° is available. The center piece defines the minimum and maximum expansion height. The distraction heights range from 20 to 132 mm.
| Implants | Height | Product number |
|---|---|---|
| obeliscTM center piece, Ø 20 mm | 20 - 28 mm | CS 2920-20 |
| 25 - 37 mm | CS 2920-25 | |
| 32 - 47 mm | CS 2920-32 | |
| 40 - 62 mm | CS 2920-40 | |
| 53 - 87 mm | CS 2920-53 | |
| 76 - 132 mm | CS 2920-76 | |
| obeliscTM end piece, Ø 20 mm | 0° | CS 2921-00 |
| 5° | CS 2921-05 | |
| 10° | CS 2921-10 | |
| obeliscTM end piece, Ø 24 mm | 0° | CS 2922-00 |
| 5° | CS 2922-05 | |
| 10° | CS 2922-10 | |
| obeliscTM end piece, Ø 26 mm | 0° | CS 2923-00 |
| 5° | CS 2923-05 | |
| 10° | CS 2923-10 | |
| obeliscTM end piece, oval,, 32 x 26 mm | 15° | CS 2924-15 |
| obeliscTM locking screw | CS 2901 |
Table: obelisc " Vertebral Body Replacement implant product list
The implant components of this system are made from alloyed titanium according to ISO 5832-3:2000 and ASTM F-136-02a.
Intended Use
Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obelise TM Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bone grafting material with the obelise™ Vertebral Body Replacement is optional.
Substantial Equivalence
2
This device is substantially equivalent to the following legally marketed devices:
| 510(k) Reference | Description | Submitted By |
|---|---|---|
| K050850 | XPAND Corpectomy | |
| Spacer | Globus Medical, Inc. | |
| K012254 | VBR TM Vertebral Body | |
| Replacement Device | Osteotech, Inc. |
A comparison of devices is provided below (table follows on next page):
| | obeliscTM Vertebral
Body Replacement | XPAND | VBRTM |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended use | Vertebral body
replacement; for use
with supplemental
spinal fixation systems | Vertebral body
replacement; for use
with supplemental
spinal fixation systems | Vertebral body
replacement; for use
with supplemental
spinal fixation systems |
| Anatomical sites | Thoracic and lumbar
spine (T1-L5) | Thoracic and lumbar
spine (T1-L5) | Thoracic and lumbar
spine (T1-L5) |
| Material | Titanium alloy | Titanium alloy | Titanium alloy |
| Bone graft
material | Narrow build to permit
external bone graft
material; may also be
filled | Axial hole for bone graft
material | Hollow core for bone
graft material |
| Diameter | 20-30mm | Various fixed heights &
footprints | 12-16mm, 20-28mm |
| Distraction length | 20-132mm | Various fixed heights &
footprints | 10-130mm |
| Exact height
adjustment in situ | Continuous in-situ
distraction | Continuous in-situ
distraction | Continuous in-situ
distraction |
| Contact areas | Large contact areas.
Additional application of
bone graft outside the
implant may enhance
the fusion mass. | N/A | Large contact areas.
Additional application of
bone graft outside the
implant may enhance
the fusion mass. |
Summary of Testing
Mechanical testing was performed in accordance with ASTM F 2077 - 00 (Test Methods for Intervertebral Body Fusion Devices.
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-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ulrich GmbH & Co. KG % Emergo Group, Inc. Mr. Ian P. Gordon Senior Vice President 2454 McMullen Booth Road, Suite 427 Clearwater, Florida 33759
Re: K060416
Trade/Device Name: obelisc™ Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 31, 2006 Received: November 1, 2006
Dear Mr. Gordon:
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.
DEC 2 6 2006
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
4
Page 2 - Mr. Ian P. Gordon
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. 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" (21 CFR 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 vours.
Barbara Buckner
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
510(k) Number (if known): Kolo 04 od of of
Device Name: obelisc™ Vertebral Body Replacement
Indications for Use:
Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obelisc™ Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bour grafting material with the obelisc™ Vertebral Body Replacement is optional.
Prescription Use XX (Part 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchm
(Division Sign Ori) Division of General, Restorative, and Neurological Devices
510(k) Number K060416