(86 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat various spinal conditions such as fractures, deformities, and spondylolisthesis, and is designed to be removed after the development of a solid fusion mass. This aligns with the definition of a therapeutic device that aims to cure, mitigate, treat, or prevent a disease.
No
The device is a spinal fixation system, intended for surgical implantation to treat various spinal conditions like fractures, deformities, and spondylolisthesis. It is not used to diagnose these conditions.
No
The device description explicitly states it consists of "various types and sizes of implantable components that are assembled to create a rigid spinal construct," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that the Zodiac DynaMo Semi-Rigid Spinal System is an implantable spinal fixation system. It is used surgically to stabilize the spine in patients with various conditions like fractures, deformities, and spondylolisthesis.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Zodiac DynaMo Semi-Rigid Spinal System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
- The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). - The Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
- In addition, the Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw fixation system is intended for:
a. Patients receiving only autogenous bone graft.
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. - The Zodiac DynaMo Semi-Rigid Spinal System , when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
Product codes
KWP, MNH, MNI
Device Description
The Zodiac DynaMo Semi-Rigid Spinal System is a top loading anterior/posterior spinal fixation system consisting of various types and sizes of implantable components that are assembled to create a rigid spinal construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic spine, lumbar spine, sacrum, thoraco-lumbo-sacral region of the spine, fifth lumbar-first sacral (L5-S1) vertebral joint.
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 and dynamic testing of the semi-rigid spinal fixation system was performed. The test results demonstrate that the mechanical performance of the Zodiac DynaMo Semi-Rigid Spinal System is substantially equivalent to the predicate device.
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
§ 888.3050 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
KOJ 2081
510(k) SUMMARY
Zodiac DynaMo Semi-Rigid Spinal System 510(k) SUMMARY July 2007
OCT 2 4 2007
| Company: | Alphatec Spine, Inc.
2051 Palomar Airport Road#100
Carlsbad, CA 92011 USA
Direct: (760) 494-6769
Fax: (760) 431-9132 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula Morgan, Director of Regulatory Affairs & Compliance |
| Trade/Proprietary Name: | Zodiac DynaMo Semi-Rigid Spinal System |
| Common Name: | Pedicle Screw Spinal Device |
| Classification Name: | Spinal Interlaminal Fixation Orthosis
Pedicle Screw Spinal System |
Product Description:
The Zodiac DynaMo Semi-Rigid Spinal System is a top loading anterior/posterior spinal fixation system consisting of various types and sizes of implantable components that are assembled to create a rigid spinal construct.
Indications for Use:
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
-
- The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
- The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
-
Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis b. with associated paralysis or spasticity).
-
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
- The Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
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1
-
- In addition, the Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw fixation system is intended for:
- Patients receiving only autogenous bone graft. a.
- b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
-
- The Zodiac DynaMo Semi-Rigid Spinal System , when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.
- Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or b. kyphoscoliosis with associated paralysis or spasticity).
- Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative C. spondylolistheses and acute pars fracture allowing spondylolisthesis).
Substantial Equivalence:
The Zodiac DynaMo Semi-Rigid Spinal System is substantially equivalent to the following predicate devices:
Trade/Proprietary Name Moss-Miami Spinal System Manufacturer DePuy Spine, Inc. Clearance K030383
Performance Data:
Mechanical and dynamic testing of the semi-rigid spinal fixation system was performed. The test results demonstrate that the mechanical performance of the Zodiac DynaMo Semi-Rigid Spinal System is substantially equivalent to the predicate device.
Fong 2.4
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized human figure with three faces in profile, representing health and well-being. The logo is rendered in black and white.
Public Health Service
0CT 2 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alphatec Spine, Inc. % Ms. Paula Morgan Director of Regulatory Affairs & Compliance 2051 Palomar Airport Road, #100 Carlsbad, California 92011
Re: K072081
Trade/Device Name: Zodiac DynaMo Semi-Rigid Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: July 27, 2007 Received: July 30, 2007
Dear Ms. Morgan:
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.
3
Page 2 – Ms. Paula Morgan
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Mark A. Milherson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): TBD
Device Name: Zodiac DynaMo Semi-Rigid Spinal System
Indications for Use:
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
-
- The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine,
- The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
-
b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
-
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
- The Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
-
- In addition, the Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw fixation system is intended for:
-
a. Patients receiving only autogenous bone graft.
-
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
Prescription Use X (Per 21 CFR 801.109)
OR
Mark A. Milleson Over The Counter Use
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K072
(PLEASE DO NOT WRITE BELOW NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
p
5
Image /page/5/Picture/0 description: The image shows the characters '(0) 2081' written in black ink on a white background. The characters are handwritten and appear to be part of a code or identifier. The numbers '2081' are clearly visible, while the '(0)' is enclosed in parentheses.
-
- The Zodiac DynaMo Semi-Rigid Spinal System , when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.
- Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or b. kyphoscoliosis with associated paralysis or spasticity).
- Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative c. spondylolistheses and acute pars fracture allowing spondylolisthesis).
Mark A. Milkerson
Division Sign. Restorative, Division of Ge and Ne
210(k) 1