(192 days)
Not Found
No
The description focuses on the mechanical design and materials of a vertebral body replacement device and does not mention any AI or ML components or functions.
Yes.
The device is a vertebral body replacement intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma to lengthen the anterior column, realigning the spinal profile, to stabilize the anterior column, and to support the consolidation of inserted bone material.
No
The AddPlus™ is a vertebral body replacement device, which is an implantable medical device used to physically replace a damaged vertebral body. Its function is to provide structural support and stabilization, not to identify or assess a medical condition.
No
The device description clearly states it is a physical, adjustable cylindrical cage made of medical grade titanium alloy, intended for surgical implantation. It also mentions associated hardware components like screws and surgical instruments.
Based on the provided text, the AddPlus™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a vertebral body replacement device for use in the thoracolumbar spine to replace damaged or unstable vertebral bodies. This is a surgical implant used directly in the human body.
- Device Description: The description details a physical implant made of titanium alloy, designed to be surgically implanted to bridge intervertebral space, lengthen the anterior column, and provide stabilization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. The AddPlus™ is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The AddPlus™ 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 AddPlus™ is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the AddPlus™ is optional.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The AddPlus™ is a modification of the 12 mm diameter VBR™ device cleared under K012254. It is an adjustable (distractable) cylindrical cage with attached fixation plates that add supplemental bilateral spinal fixation to the design of the marketed VBR™ device. The device remains constructed from medical grade titanium alloy. In the case of resected vertebral bodies of the human spine, the AddPlus™ is used for bridging the intervertebral space and serves to lengthen the anterior column, realigning the spinal profile, to stabilize the anterior column, and to support the consolidation of inserted bone material.
The attached fixation plates serve to provide further fixation and stabilization and to prevent migration as well as possible sinking in of the implant. The device is available in one diameter (i.e., 12 mm), four expansion ranges (i.e., 13 - 18 mm, 17 - 26 mm, 25 - 41 mm, and 40 - 65 mm), and four angles (i.e., 0°, 6°, 12°, and 18°).
Available components to be used with the AddPlus™ include a locking screw, osmium™ screw. and cancellous bone screw. The locking screw is used to fix the height of the adjusted AddPlus™4. The osmium™ screw is used for monocortical fixation. It is available in lengths of 14, 16, and 18 mm, with a diameter of 5 mm. The cancellous bone screw is used for bicortical fixation. It is available in lengths of 12, 14, 16, 18, 20, 24, and 26 mm, with a diameter of 4 mm. In addition to these device components, a number of surgical instruments are available for use during implantation of the device.
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 applicable recommendations of FDA guidance titled "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," dated May 2004, was conducted to demonstrate equivalence to the predicate devices and demonstrated the subject device's capability to withstand anticipated in vivo loads.
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.
VBR™ (K012254)
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
510(k) SUMMARY
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87
OCT - 5 2009
Establishment Registration Number:
9612420
Merle Symes
President and CEO ulrich medical USA 754 Spirit 40 Park Drive Chesterfield, MO 63005
28 September 2009
ulrich GmbH & Co. KG Buchbrunnenweg 12 89081 Ulm, Germany
Address of Manufacturer:
Contact Person:
Date Prepared:
Trade or Proprietary Name:
AddPlus™, Anterior Distraction Device Plus
Common or Usual Name:
Classification Name:
Spinal intervertebral body fixation orthosis (21 CFR 888.3060)
Vertebral body replacement device
Product code: MQP
Class II
Predicate Device Identification:
VBR™ (K012254)
Device Description:
The AddPlus™ is a modification of the 12 mm diameter VBR™ device cleared under K012254. It is an adjustable (distractable) cylindrical cage with attached fixation plates that add supplemental bilateral spinal fixation to the design of the marketed VBR™ device. The device remains constructed from medical grade titanium alloy. In the case of resected vertebral bodies
Company Confidential
Page 13 of 84
1
of the human spine, the AddPlus™ is used for bridging the intervertebral space and serves to lengthen the anterior column, realigning the spinal profile, to stabilize the anterior column, and to support the consolidation of inserted bone material.
The attached fixation plates serve to provide further fixation and stabilization and to prevent migration as well as possible sinking in of the implant. The device is available in one diameter (i.e., 12 mm), four expansion ranges (i.e., 13 - 18 mm, 17 - 26 mm, 25 - 41 mm, and 40 - 65 mm), and four angles (i.e., 0°, 6°, 12°, and 18°).
Available components to be used with the AddPlus™ include a locking screw, osmium™ screw. and cancellous bone screw. The locking screw is used to fix the height of the adjusted AddPlus™4. The osmium™ screw is used for monocortical fixation. It is available in lengths of 14, 16, and 18 mm, with a diameter of 5 mm. The cancellous bone screw is used for bicortical fixation. It is available in lengths of 12, 14, 16, 18, 20, 24, and 26 mm, with a diameter of 4 mm. In addition to these device components, a number of surgical instruments are available for use during implantation of the device.
Intended use and comparison to predicate devices:
The AddPlus™ 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 AddPlus™ is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the AddPlus™ is optional.
Technological characteristics and comparison to predicate devices:
A comparison of the subject and predicate devices identified technical differences in geometrical configurations. Similarity was noted with regards to material of construction.
The differences in technological characteristics between the subject and predicate devices do not raise new types of safety or effectiveness questions. Accepted scientific methods, such as performance (bench) testing, do exist for assessing the effect of the differences in characteristics.
Summary of performance data:
Mechanical testing, in accordance with applicable recommendations of FDA guidance titled "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," dated May 2004, was conducted to demonstrate equivalence to the predicate devices and demonstrated the subject device's capability to withstand anticipated in vivo loads.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ulrich GmbH & Company KG % Ulrich Medical USA Mr. Merle Symes President and Chief Executive Officer 754 Spirit 40 Park Drive Chesterfield, Missouri 63005
OCT - 5 2009
Re: K090841
Trade/Device Name: AddPlus™, Anterior Distraction Device Plus Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: September 28, 2009 Received: September 29, 2009
Dear Mr. Symes:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Merle Symes
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090841
Device Name: AddPlus™, Anterior Distraction Device Plus
Indications for Use:
The AddPlus™ 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 AddPlus™ is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the AddPlus™ is optional.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: (21 CFR 807 Subpart C)
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090841
Company Confidential