(202 days)
Not Found
No
The 510(k) summary describes a purely mechanical vertebral body replacement device with no mention of AI or ML in its intended use, device description, or performance studies.
Yes
The device is intended to replace vertebral bodies and provide support in the spine after trauma or tumor removal, which directly addresses a pathological condition and restores function.
No
Explanation: The device description clearly states it is a "Vertebral Body Replacement," a hollow cylinder used to provide structural support after a vertebral body is removed or resected. This is a therapeutic implant, not a diagnostic tool.
No
The device description clearly indicates a physical, implantable device made of material with specific dimensions and features (hollow cylinder, diameter, height, wall thickness, holes, teeth). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to replace a vertebral body in the spine. This is a therapeutic device used in vivo (within the body) to provide structural support.
- Device Description: The description details a physical implant (hollow cylinder with specific dimensions and features) made for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are used for diagnostic purposes by analyzing samples outside the body. This device is a surgical implant used for structural support within the body.
N/A
Intended Use / Indications for Use
The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).
The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The SSP Vertebral Body Replacement is a hollow cylinder available in either 12 mm or 14 mm diameter, with height ranging from 7 mm to 13 mm in 1 mm increments. The various sizes of these implants accommodate individual patient anatomy and pathology. Wall thickness is approximately 1.5 mm. The wall of the device features an open architecture consisting of one or two rows of circumferential holes (depending on height). The ends are notched circumferentially to form a row of "teeth" along the superior and inferior margins.
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)
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
SSP Vertebral Body Replacement
510(k) Summary
DEC 26 2006
Specialty Spine Products SSP Vertebral Body Replacement
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Specialty Spine Products, LLC |
|---|---|
| 4121 Tigris Way | |
| Riverside, CA 92503 | |
| Telephone 1 (951) 687-2808 | |
| Fax 1 (951) 734-7594 | |
| Official Contact: | Angela Carlson |
| Representative/Consultant: | Floyd G. Larson |
| PaxMed International, LLC | |
| 11234 El Camino Real, Suite 200 | |
| San Diego, CA 92130 | |
| Telephone 1 (858) 792-1235 | |
| FAX 1 (858) 792-1236 |
DEVICE NAME
| Classification Name: | Spinal intervertebral body fixation orthosis |
|---|---|
| Trade/Proprietary Name: | SSP Vertebral Body Replacement |
| Common Name: | Spinal vertebral body replacement device |
ESTABLISHMENT REGISTRATION NUMBER
Specialty Spine Products will submit Establishment Registration to FDA prior to marketing the SSP Vertebral Body Replacement.
DEVICE CLASSIFICATION
Spinal vertebral body replacement devices are classified as Class II devices (21 CFR 888.3060). The product code for Spinal intervertebral body fixation orthosis is MQP. This device classification is reviewed by the Orthopedic Branch.
1
INTENDED USE
The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).
The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.
DEVICE DESCRIPTION
The SSP Vertebral Body Replacement is a hollow cylinder available in either 12 mm or 14 mm diameter, with height ranging from 7 mm to 13 mm in 1 mm increments. The various sizes of these implants accommodate individual patient anatomy and pathology. Wall thickness is approximately 1.5 mm. The wall of the device features an open architecture consisting of one or two rows of circumferential holes (depending on height). The ends are notched circumferentially to form a row of "teeth" along the superior and inferior margins.
EQUIVALENCE TO MARKETED PRODUCT
Specialty Spine Products, LLC has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SSP Vertebral Body Replacement is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: the SynMesh Spacer System (K003275) from Synthes, the Blackstone Surgical Titanium Mesh System (K030744) from Blackstone Medical, and the Blackstone Surgical Titanium Mesh System Angled End Rings (K032700), also from Blackstone Medical.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Specialty Spine Products, LLC % Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
DEC 9 6 2006
Re: K061578
Trade/Device Name: SSP Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 5, 2006 Received: June 7, 2006
Dear Mr. Larson:
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.
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Page 2 - Mr. Floyd G. Larson
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,
Houbare Bueckup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K061578
Device Name: SSP Vertebral Body Replacement
Indications for Use:
The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 -- L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).
The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
-The-Counter Use
(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 Bruchun
(Division Sign-Off)(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K061578 Rev 061222 Page 1 of 10
510(k) Number K061578