(163 days)
KWP
Not Found
No
The description focuses on the mechanical design and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for fixation to adjacent spinous processes in conjunction with anterior interbody fusion and bone graft for conditions such as spinal trauma, degenerative spondylolisthesis, and degenerative disc disease, which are therapeutic medical interventions.
No
The device is described as an implantable spinous process plate intended for fixation and used as an adjunct to anterior interbody fusion, not for diagnosing medical conditions.
No
The device description clearly states it consists of "spinous process plates and interconnecting male and female grommets," which are physical implants, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Spinous Process Plate is an implantable device intended for fixation to adjacent spinous processes (L1-L5). It is a physical device used in surgery to stabilize the spine.
- Intended Use: The intended use is for fixation as an adjunct to anterior interbody fusion and bone graft, addressing conditions like spinal trauma, degenerative spondylolisthesis, and degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Tandem Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, degenerative spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.
Product codes
KWP
Device Description
The Tandem system consists of spinous process plates and interconnecting male and female grommets. The implants are used in combination with a vertebral body replacement device such as the Spinal Concepts, Inc. InFix System. The plates feature a slim profile, several rows of spikes, and holes on each end with a spherical seat for grommet attachment. The spikes around the plate holes resist plate rotation after implantation, while a row of spikes over the intraspinous ligament aids in fixation to any optional bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
adjacent spinous processes (L1-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 demonstrated that the Tandem System exhibits the functional requirements to support its use as a spinous process plate system under normal physiologic loads in the spine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Meurig-Williams Plate
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
K040096 Page 1 of 1
Spinal Concepts, Inc. Tandem Spinous Process Plate System
510(k) Summary of Safety and Effectiveness
JUL 0 1 2004
| SUBMITTED BY | Spinal Concepts, Inc.
5301 Riata Park Court, Bldg. F
Austin, TX 78727 |
|--------------------------------------|-----------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 1649384 |
| CONTACT PERSON | Lisa Peterson
Regulatory Affairs Specialist |
| DATE PREPARED | January 14, 2004 |
| CLASSIFICATION NAME | Spinal interlaminal fixation orthosis, 21 CFR 888.3050. Class II. |
| COMMON NAME | Posterior Spinal Fixation System |
| PROPRIETARY NAME | Spinal Concepts, Inc. Tandem Spinous Process Plate System |
| PREDICATE DEVICES | Meurig-Williams Plate |
DEVICE DESCRIPTION
The Tandem system consists of spinous process plates and interconnecting male and female grommets. The implants are used in combination with a vertebral body replacement device such as the Spinal Concepts, Inc. InFix System. The plates feature a slim profile, several rows of spikes, and holes on each end with a spherical seat for grommet attachment. The spikes around the plate holes resist plate rotation after implantation, while a row of spikes over the intraspinous ligament aids in fixation to any optional bone graft.
INDICATIONS
The Tandem Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, degenerative spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.
MECHANICAL TEST DATA
Mechanical testing demonstrated that the Tandem System exhibits the functional requirements to support its use as a spinous process plate system under normal physiologic loads in the spine.
1
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 01 2004
Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727
Re: K040096
Trade Name: Tandem Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: April 15, 2004 Received: April 20, 2004
Dear Ms. Peterson:
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.
2
Page 2 - Ms. Lisa Peterson
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. 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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost.
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
3
INDICATIONS FOR USE STATEMENT
Page 1 of 1
K040096 510(k) Number (if known):
Spinal Concepts, Inc. Tandem Spinous Process Plate System Device Name:
Indications for Use:
The Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-I no adjunct to anterior interbody fusion and bone graft. The indications for the E7 as an adjance to ancerior issinal trauma, spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.
(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) | X |
|---|---|
| OR | |
| Over-The-Counter: (Optional Format 1-2-96) |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040096