(82 days)
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. Vertebral staples are limited to use with 5.5mm and larger monoaxial screws only.
- The ZODIAC™ Spinal Fixation 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). - The ZODIAC™ Spinal Fixation 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™ Spinal Fixation 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 (L3-S1) and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. - The ZODIAC™ 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 scolliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis). - When used as an anterior fixation system, the ZODIAC Spinal Fixation System intended for degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumors and/or failed previous fusion.
The ZODIAC™ Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium allov or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.
The provided document describes a medical device, the ZODIAC™ Spinal Fixation System, and its clearance through the 510(k) pathway. This pathway relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit performance against predefined acceptance criteria from a clinical study.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable as this submission is for a spinal fixation system, which typically involves mechanical and biocompatibility testing, not diagnostic performance studies with human readers.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What would normally be tested clinically) | Reported Device Performance (as per 510(k)) |
|---|---|
| Not specified (clinical performance is not the primary focus of this 510(k) submission type) | Mechanical and dynamic testing was performed. |
| e.g., Clinical success rates, complication rates, fusion rates (for clinical trials) | Test results demonstrated that the ZODIAC™ Spinal Fixation System is at least comparable to, if not better than those of the predicate devices. |
| Substantial Equivalence to Predicate Devices | Documentation was provided that demonstrates that the ZODIAC™ Spinal Fixation System is substantially equivalent to other pedicle screw systems currently on the market. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable for a 510(k) for a spinal fixation system that relies on mechanical testing and substantial equivalence. The "test set" in this context refers to the samples used in mechanical and dynamic testing of the device hardware, not a clinical data set. The document does not specify the number of individual implants or components tested.
- Data Provenance: The testing was presumably conducted by the manufacturer, Alphatec Manufacturing, Inc., or a contracted lab. The document does not specify the country of origin of this testing data. It is a retrospective summary of testing performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a hardware device (spinal fixation system), not a diagnostic algorithm where expert ground truth is established for a test set. The "ground truth" here would be the physical properties derived from mechanical testing specifications and comparison to predicate devices, which are assessed by engineers and regulatory bodies.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human readers or expert consensus involved in establishing a ground truth for a diagnostic test set in this context, there is no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
- No, an MRMC study was NOT done. This device is a spinal fixation hardware system, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was NOT done. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Engineering specifications and performance of predicate devices. For a device like the ZODIAC™ Spinal Fixation System, the "ground truth" for its performance evaluation in a 510(k) is based on:
- Mechanical and Dynamic Testing Standards: The device's physical properties (e.g., strength, fatigue resistance) are tested against established engineering standards and specifications.
- Predicate Device Performance: The central claim of a 510(k) is substantial equivalence. The "ground truth" for this claim is a comparison of the device's design, materials, and performance (including mechanical testing) to that of legally marketed predicate devices, which are already considered safe and effective for their intended use.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware device, not an AI/ML algorithm. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this device, there is no ground truth established for it.
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K050830 ZODIAC™ Spinal Fixation System 510(k) SUMMARY Page 1 of 2
JUN 2 2 2005 Alphatec Manufacturing, Inc. Company: 6110 Corte Del Cedro Carlsbad, CA 92009 USA Telephone: (760) 431-9286 Fax: (760) 431-9132
Contact Person: Ellen Yarnall, Director of Regulatory Affairs
ZODIAC™ Spinal Fixation System Trade/Proprietary Name:
Common Name: Pedicle Screw Spinal System
Spinal Interlaminal Fixation Orthosis (888.3050)(KWP) Classification Name: Spinal Intervertebral Body Fixation Orthosis (888.3060)(KWQ) Spinal Pedicle Fixation (888.3070)(MNI) Orthosis, Spondylolythisis Spinal Fixation (888.3070)(MNH)
Product Description:
The ZODIAC™ Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium allov or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.
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™ Spinal Fixation 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™ Spinal Fixation 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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K050830 ZODIAC™ Spinal Fixation System 510(k) SUMMARY Page 2 of 2
-
- In addition, the ZODIAC™ Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
- a. Patients receiving only autogenous bone graft.
- a. Patients having the device fixed or attached to the lumbar and sacral atients having the dovice institution is grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
-
- The ZODIAC™ 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, Patients having thoraooliambardosis with associated paralysis or spasticity).
- spastiony)
Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, r ationto naving spondylolistheses and acute pars fracture allowing spondylolisthesis).
-
- When used as an anterior fixation system, the ZODIAC Spinal Fixation virien used as an antenor maxicative disc disease (as defined by back pain of System is intendou for degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal and radiographis scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumors and/or failed previous fusion.
Substantial Equivalence:
Documentation was provided that demonstrates that the ZODIAC™ Spinal Fixation System Documentally equivalent to other pedicle screw systems currently on the market.
Performance Data:
Mechanical and dynamic testing was performed. Test results demonstrated that the Mechanical and "Gylamic" (Colling" wao" poninal Fixation System is at least comparable to, if not better than those of the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and two curved lines representing the body.
JUN 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ellen Yarnall Director of Regulatory Affairs Alphatec Manufacturing Incorporated 6110 Corte Del Cedro Carlsbad, California 92009
Re: K050830
Trade/Device Name: ZODIAC™ Spinal Fixation System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 (b) (1) Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation system and pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ, MNI, MNH Dated: March 31, 2005 Received: April 6, 2005
Dear Ms. Yarnall:
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 for about in 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 r ou mayy are s 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 -- Ms. Ellen Yarnall
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to obgin manteang your antial equivalence of your device to a legally premits in the results in . The PDT Intentig sification 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 If you desire specific advice tor your do not on one of the regulation entitled, Coniact the Office of Compuners and (21 transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ech
Miriam C. Provost, Ph.D. Acting 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 (Page 1 of 1)
510(k) Number (if known): K050830
ZODIAC™ Spinal Fixation System Device Name:
Indications for Use:
lt is intended that this device, in any system configuration be removed after development of solid fusion
if the same lt is intended that this device, in any system communici colonions are limited to the sacrum
mass. Hook component indications are limited to TT-L5. Sacral screw indication mass. Hook component indications are imited to 11 Le. Gudder Shows
only. Vertebral staples are limited to use with 5.5mm and larger monoaxial screws only.
- The ZODIAC™ Spinal Fixation System when used as a hook and sacral screw fixation system 1) (nonpedicle screw) is intended for:
- Patients having fractures of the thoracic and lumbar spine.
- a. Patients having tractures of the thoracic and fumber opine.
Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis b. with associated paralysis or spasticity). - with associated paralysis of spastleity).
Patients having spondylolisthesis (i.e., isthmic spondylolisthesis) C. Patterits naving spondylolisthesis (f.o., lochinis spondylolisthesis).
- The ZODIAC™ Spinal Fixation System, when used as a pedicle screw system in the thoraco-2) The ZODIAC™ Spine is intended for degenerative spondylishtesis with objective
lumbo-sacral region of the spine is intended for degenerative spondylalster lumbo-sacral region of the spine is intended for dogenerative spinal tumor and failed previous fusion (pseudoarthrosis). - In addition, the ZODIAC™ Spinal Fixation System, when used as a pedicle screw fixation 3) system is intended for:
- a. Patients receiving only autogenous bone graft.
- a. Patients receiving only autogenous Bone gran.
b. Patients having the device fixed or attached to the lumbar and having Patients having the device ilxed of attached to the famible the sacral (L5-S1) vertebral joint.
severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1)
- The ZODIAC™ Spinal Fixation System, when used as a laminar hook and bone screw system 4) is intended for:
- Patients having fractures of thoracic and lumbar spine. ਕ.
- Patients having fractures of thoracle and fambal opino.
Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scolliosis, or b. kyphoscoliosis with associated paralysis or spasticity). - kyphoscollosis with associated paraiyals of opaonally, "
Patients having spondylolisthesis (i.e., isthmic spondylolisthesis) C. Patterits naving Spondylolisthoulo (non loculowing spondylolisthesis).
- When used as an anterior fixation system, the ZODIAC Spinal Fixation System intended for 5. When used as an antenor ikation system, the 20Dire "spinance oncin with degeneration of
degenerative disc disease (as defined by back pain of discogencion with degeneration o the disc confirmed by patient history and radiographic studies), spinal stemosis, the disc commied by patient motory and reading to be recolinsis, and/or lordosis), fracture, pseudarthrosis, tumors and/or failed previous fusion.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The Counter Use (21 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) |
|---|
| -------------------------------------------------------- |
Civision Sign-Off) Division of General, Restorative and Neurological Devices
(k) Number Kososky
§ 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.