(84 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fusion system consisting of screws, hooks, rods, and connectors. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The device's function is purely structural support for spinal fusion.
Yes
The device is indicated to "promote fusion of the cervico-thoracic regions of the spine" and "provide stabilization to promote fusion," which are therapeutic actions aimed at treating spinal conditions.
No
The device description clearly states it is "intended for use as an aid in spine fusion" and "consists of screws, hooks, rods, and connectors." These are medical implants used to stabilize the spine, not to detect or diagnose medical conditions.
No
The device description explicitly states it consists of physical components (screws, hooks, rods, and connectors) made from titanium alloy, indicating it is a hardware-based medical 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Atoll Cervico-Thoracic System is described as a system of screws, hooks, rods, and connectors made of titanium alloy. These are physical implants intended to be surgically placed in the spine.
- Intended Use: The intended use is to promote fusion and provide stabilization in the spine for various conditions. This is a therapeutic and structural function, not a diagnostic one performed on samples outside the body.
The device is clearly a surgical implant used in vivo (within the body) for structural support and fusion, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 – T3). The intended indications are as follows:
• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
- . Spinal Stenosis
- Fracture/Dislocation ●
- Deformities or Curvature t
- Tumors
- Pseudoarthrosis t
- . Revision of previous cervical and upper thoracic spine surgery
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Product codes (comma separated list FDA assigned to the subject device)
KWP 888.3050, MNI 888.3070(b)(1)
Device Description
The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology.
The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.
To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervico-thoracic regions of the spine (C1 – T3), upper thoracic spine (T1-T3), cervical/upper thoracic (C1-T3) spine
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
§ 888.3050 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
| Theken Spine | |||
|---|---|---|---|
| -------------- | -- | -- | -- |
Atoll Cervico-Thoracic System
3/5/2007
510(K) Summary
(21 CFR Part 807.92)
A. Submitter Information
| Submitter's Name: | Theken Spine, LLC | MAY 30 2007 |
|---|---|---|
| Address: | 283 E. Waterloo | |
| Akron, Ohio 44319 | ||
| Telephone Number: | 330-773-7677 x221 | |
| Fax Number: | 330-773-7697 | |
| Contact Person: | Dale Davison | |
| Date Prepared: | 05 March 2007 | |
| B. Device Information | ||
| Trade Name: | Atoll™ Cervico-Thoracic System | |
| Common Name: | Posterior Cervical Instrumentation | |
| Classification: | Class II System with the corresponding product codes: | |
| KWP 888.3050 - Spinal Interlaminal Fixation Orthosis | ||
| MNI 888.3070(b)(1) - Pedicle Screw Spinal System | ||
| Predicate Device: | Synthes (USA) – Cervifix System (K990965)/Starlock System | |
| Medtronic Sofamor Danek USA, Inc. – VERTEX Reconstruction System (K003780) | ||
| DePuy-AcroMed, Inc.-Summit Occipito-Crevico-Thoracic (OCT) Spinal System (K002733) | ||
| Material Composition: | Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 | |
| Subject Device Description: | The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology. |
The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.
To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer. | |
| Intended Use: | The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 – T3). The intended indications are as follows:
• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis | |
1
- . Spinal Stenosis
- Fracture/Dislocation ●
- Deformities or Curvature t
- Tumors
- Pseudoarthrosis t
- . Revision of previous cervical and upper thoracic spine surgery
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Substantial Equivalence ပဲ
The characteristics of the Atoll Cervico-Thoracic System are similar to the following predicate devices:
-
- CerviFix System (K990965)/Starlock System manufactured by Synthes (USA) and cleared by the FDA on July 1, 1999.
- VERTEX™ Reconstruction System (K003780) manufactured by Medtronic 2. Sofamor Danek USA, Inc. and cleared by the FDA on September 28, 2001
-
- Summit OCT Spinal System (K002733) manufactured by DePuy AcroMed, Inc and cleared by the FDA on December 15, 2000.
Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices. Therefore, Theken Spine believes that there is sufficient evidence to conclude that the Atoll Cervico-Thoracic System is substantially equivalent to existing legally marketed devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
AUG 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Theken Spine % Mr. Dale Davison Vice President of Engineering 283 E. Waterloo Road Akron, Ohio 44319
K070638 Re: Trade/Device Name: Atoll™ Cervico-Thoracic System Regulation Number: 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP and MNI Dated: March 5, 2007 Received: March 7, 2007
Dear Mr. Davison:
This letter corrects our substantially equivalent letter of May 30, 2007.
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 (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 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
3
Page 2 - Mr. Dale Davison
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 continue 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 or view their Internet address http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Kaibare Buchen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K0706838
Device Name: Theken Atoll Cervico-Thoracic System
Indications For Use: The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1-T3). The intended indications are as follows: degenerative disc disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; tumors; pseudoarthrosis; and revision of previous cervical and upper thoracic spine surgery.
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED | RH, Office of Device Evaluation (ODE) Division of
and Neurological Devices
510(k) Number K020638