ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
Device Facts
| Record ID | K100685 |
|---|---|
| Device Name | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
| Applicant | Alphatec Spine, Inc. |
| Product Code | KWP · Orthopedic |
| Decision Date | Jun 18, 2010 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. 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-iliac screw indications are limited to the sacrum-iliac crest only.
Device Story
Posterior spinal fixation system; provides stabilization during bone graft fusion. Components include pedicle screws, laminar hooks, and sacral-iliac screws. Used in thoraco-lumbo-sacral iliac region. Operated by surgeons in clinical/OR settings. Device configuration varies by pathology; provides mechanical stabilization to spine. Removed after solid fusion achieved. Benefits include correction of deformities and stabilization of fractures/pathologies.
Clinical Evidence
No clinical data. Evidence consists of bench testing only. Mechanical and dynamic testing performed per ASTM F1717, including static compression, static torsion, and dynamic compression run-out. Simulated derotation testing performed to evaluate torsional stability of updated Uniplanar screw versus predicate.
Technological Characteristics
Materials: Titanium Alloy (ASTM F136/F67), Stainless Steel (ASTM F138/F2229), Cobalt Chrome (ASTM F799/F1537). Polyaxial and Uniplanar screw configurations. Mechanical fixation via pedicle screws, laminar hooks, and sacral-iliac screws. No software or electronic components.
Indications for Use
Indicated for patients with thoracic/lumbar fractures, spinal deformities (idioscoliosis, neuromuscular scoliosis, kyphoscoliosis with paralysis/spasticity), spondylolisthesis (isthmic, degenerative, acute pars fracture), degenerative spondylolisthesis with neurologic impairment, dislocation, spinal tumor, failed previous fusion (pseudoarthrosis), and severe grade 3/4 spondylolisthesis at L5-S1. Used with autograft or allograft bone. Hook use limited to T7-L5; sacral-iliac screws limited to sacrum-iliac crest.
Regulatory Classification
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.
Predicate Devices
- Zodiac® Polyaxial Spinal Fixation System (K033090)
- Zodiac® Polyaxial Spinal Fixation System (K042673)
- Zodiac® Stainless Steel Spinal Fixation System (K051286)
- Zodiac® 4.0 Polyaxial Spinal Fixation System (K071890)
- Zodiac® Polyaxial Spinal Fixation System (K093077)
Submission Summary (Full Text)
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Zodiac® Polyaxial Spinal Fixation System
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## 510(k) SUMMARY
# Zodiac® Polyaxial Spinal Fixation System March 2010
Company: Alphatec Spine, Inc. 5818 El Camino Real JUN 1 8 2010 Carlsbad, CA 92008 Direct: (760) 494-6770 Fax: (760) 431-0289 Contact Person: Cheryl Allen, Regulatory Affairs Submissions Specialist Trade/Proprietary Name: Zodiac® Polyaxial Spinal Fixation System Common Name: Pedicle Screw Spinal Device Classification Names: Spinal Interlaminal Fixation Orthosis Pedicle Screw Spinal System Classification Number(s)/Product Code(s): 21 CFR 888.3050, 888.3070 KWP, MNI. MNH
### Product Description:
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral liac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. The Zodiac® Polyaxial Spinal Fixation System unplants are manufactured from Titanium Alloy conforming to ASTM F136 or ASTM F67, Stainless Steel conforming to ASTM F138 or ASTM F2229, or Cobalt Chrome conforming to ASTM F799 or ASTM F1537.
## Indications for Use:
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
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-iliac screw indications are limited to the sacrum-iliac crest only.
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1. The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac 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).
2. The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving autograft or allograft bone.
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Zodiac® Polyaxial Spinal Fixation 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, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
## Substantial Equivalence:
The Zodiac® Polyaxial Spinal Fixation System additional components are substantially equivalent to the following predicate device:
| Trade/Proprietary/Model Name | Manufacturer | 510(k) No. |
|------------------------------------------------|----------------------|------------|
| Zodiac® Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | K033090 |
| Zodiac® Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | K042673 |
| Zodiac® Stainless Steel Spinal Fixation System | Alphatec Spine, Inc | K051286 |
| Zodiac® 4.0 Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | K071890 |
| Zodiac® Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | K093077 |
### Performance Data:
Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. The testing demonstrated that additional components are substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices.
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Zodiac® Polyaxial Spinal Fixation System
Image /page/2/Picture/1 description: The image shows the Greek letter alpha in a cursive font above the words "Alphatec Spins" in a bold, italicized font. The alpha symbol is larger than the text below it, drawing the eye to the symbol first. The text is slightly blurred, suggesting it may be a logo or brand name.
The following preclinical testing was performed:
## ASTM F1717 Mechanical Testing.
Conclusions:
- Static compression values are equivalent to the previously cleared legally marketed Alphatec 1. Spine predicate devices.
- Static torsion values are equivalent to previously cleared legally marketed Alphatec Spine 2. predicate devices confirming substantial equivalence.
- The critical dynamic compression run out value is identical to the previously cleared legally 3. marketed Alphatec Spine predicate devices confirming substantial equivalence.
# Simulated Derotation Testing:an evaluation of the torsional stability provided by the updated Uniplanar screw and the previously cleared Uniplanar screw.
Conclusion:
- ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ Testing of the Uniplanar screw s showed a much higher ultimate moment during torsional loading compared to the predicate.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
JUN 1 8 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Alphatec Spine, Inc. % Ms. Cheryl Allen Regulatory Affairs Submissions Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K100685
Trade/Device Name: Zodiac® Polyaxial Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI, MNH Dated: May 20, 2010 Received: May 21, 2010
Dear Ms. Allen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Cheryl Allen
CFR Part 807); labeling (21 CFR Part 801); medical device 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.
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/ycm115809.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/ReportaProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ваввадниева
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Zodiac® Polyaxial Spinal Fixation System
# INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Zodiac® Polyaxial Spinal Fixation System
### Indications for Use:
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation 1116 2001ac - 1 ofyaxian Optical I manon of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the mondations for the assembled device and the method of attachment to the spine.
It is intended that this device, in any system configuration, be removed after development of solid It is mended that this de roo, in ally of one limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.
1. The Zodiae Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
a. Tatients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity).
associated paratysis of Spassions //
c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral illiac 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).
Page 1 of 2
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/6/Picture/2 description: The image shows the letter 'a' in cursive, followed by the words "Alphatec Spine" in a bold, italicized font. The letter 'a' is positioned above the words, creating a logo-like appearance. The text is black against a white background.
3. In addition, the Zodiac Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving autograft or allograft bone.
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Zodiac® Polyaxial Spinal Fixation 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,
kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
Prescription Use X (Per 21 CFR 801.109)
ાર
Over-The Counter Use --------
Page 2 of 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K 100685 510(k) Number_
