(38 days)
Not Found
No
The document describes a mechanical implant (anterior cervical plate fixation system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is marketed for treating conditions such as trauma, deformity, pseudoarthrosis, degenerative disk disease, and spinal canal stenosis, which are medical conditions, and its intended use is to stabilize the spine and act as an internal fixation device for arthrodesis.
No
The Dogbone ACFS is described as an "internal fixation device" intended for "stabilizing the spine" and used "during the time interval required for arthrodesis." It is a physical implant, not a device used to identify, measure, or monitor a medical condition.
No
The device description clearly states it is a "titanium alloy anterior cervical plate fixation system" and describes physical components like plates, screws, and locking fingers. This indicates a hardware-based medical device, not software-only.
Based on the provided information, the Dogbone ACFS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Dogbone ACFS Function: The description clearly states that the Dogbone ACFS is a titanium alloy anterior cervical plate fixation system used for stabilizing the spine from C2 to C7. It is an implantable device used during surgery to provide structural support.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, laboratory testing, or diagnostic purposes. Its function is purely mechanical and structural.
Therefore, the Dogbone ACFS falls under the category of a surgical implant or medical device used for fixation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dogbone ACFS is indicated for trauma, deformity (lordosis and kyphosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenosis.
The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicortical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This product may be employed as an internal fixation device during the time interval required for arthrodesis.
Product codes
KWG
Device Description
The Dogbone ACFS is a titanium alloy anterior cervical plate fixation system. Plates are pre-contoured in two planes, and come in a variety of lengths. Screws arc available in two diameters, several lengths, and two different styles; fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs combining elements of fixed and variable angle screws may be built also. Eight locking tingers circumferentially disposed around the rim of each screw hole engage the screw heads to provide mechanical resistance against screw back-out.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to C7
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)
Non-clinical:
Static and fatigue cantilever axial compression testing was performed. Properties of stiffness, strength, and fatigue life were characterized. Static torsion was also examined.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)
Reference Device(s)
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
FEB
510(k) Summary
Dogbone ACFS
510 (k) Summary
- Company: Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203
Trade Name: Dogbone ACFS
Classification: KWG 888.3060, Spinal Intervertebral Body Fixation Orthosis. Class II.
- The Dogbone ACFS is a titanium alloy anterior cervical plate fixation system. Description: Plates are pre-contoured in two planes, and come in a variety of lengths. Screws arc available in two diameters, several lengths, and two different styles; fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs combining elements of fixed and variable angle screws may be built also. Eight locking tingers circumferentially disposed around the rim of each screw hole engage the screw heads to provide mechanical resistance against screw back-out.
Performance Data:
Non-clinical:
Static and fatigue cantilever axial compression testing was performed. Properties of stiffness, strength, and fatigue life were characterized. Static torsion was also examined.
Intended Use;
The Dogbone ACFS is indicated for:
The Dogbone ACFS is indicated for trauma, deformity (lordosis and kyphosis). oseudoarthrosis, previously failed cervical soine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenosis.
The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicortical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This product may be employed as an internal fixation device during the time interval required for arthrodesis.
The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicortical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This product may be employed as an internal fixation device during the time interval required for anthrodesis.
Substantial Equivalence:
Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)
1
Public Health Service
FEB 4 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lukas Eisermann Director, Regulatory Affairs Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203
Re: K994383 Trade Name: Dogbone ACFS Regulatory Class: II Product Code: KWQ Dated: December 27, 1999 Received: December 28, 1999
Dear Mr. Eisermann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
2
Page 2 - Mr. Lukas Eisermann
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil K.P. Ogden
James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
610/k) Number K994383
510 {k} Number {if known):
Device Name: Dogbone ACFS
-
- Indications for Use:
The Dogbone ACFS is indicated for trauma, deformity (lordosis and kyphosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenosis.
- Indications for Use:
The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicontical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This product may be employed as an internal fixation device during the time interval required for arthrodesis.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1/2/96)
DRO for JZD
(Division Sign-Off) Division of General Restorative Devices 994393 510(k) Number