(143 days)
Not Found
No
The description focuses on the material properties and mechanical function of a biodegradable implant, with no mention of AI or ML.
Yes
The device is described as a "Biodegradable Anterior Cervical Fusion System" intended for use in "cervical spinal fusion procedures" to "maintain the relative position of weak bony tissue." These functions directly involve the treatment and stabilization of a medical condition.
No
The device is a system for cervical spinal fusion procedures, intended to maintain the relative position of weak bony tissue. It does not perform any diagnostic function.
No
The device description explicitly states it consists of "cervical spinal fusion plates and screws" made of a resorbable material, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant used in cervical spinal fusion procedures. It's a physical device (plates and screws) made of biodegradable material that is implanted into the body to help stabilize bone grafts.
- Intended Use: The intended use is to "maintain the relative position of weak bony tissue" during spinal fusion. This is a mechanical function performed within the body, not a diagnostic test performed on a specimen outside the body.
The information provided clearly indicates this is a medical device used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The INION S-1™ BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.
Product codes
KWQ, HWC, OJB
Device Description
Inion S-1™ Biodegradable Anterior Cervical Fusion System, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion rigit fixances (10), posterinain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.
Inion S-1 ™ Biodegradable Anterior Cervical Fusion System consist of cervical spinal fusion plates and screws, and is made of resorbable polylactic acid copolymers, P(L/DL)LA 80:20.
Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years.
Inion S-1 ™ Biodegradable Anterior Cervical Fusion System is provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spinal
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)
Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years.
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
§ 888.3060 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
NOV 25 2005
510(k) SUMMARY for Inion S-1™ Biodegradable Anterior Cervical Fusion System
MANUFACTURER Inion Ltd., Lääkärinkatu 2, FIN-33520 Tampere, FINLAND
Contact Person Hanna Marttila, Regulatory Affairs Director Lääkärinkatu 2, FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 691 hanna.marttila@inion.com
DEVICE NAME
Trade name: Inion S-1 ™ Biodegradable Anterior Cervical Fusion System
ESTABLISHMENT REGISTRATION NUMBER
9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Class : II Classification Panel: Orthopedic
Regulation number: 21 CFR 888.3060 Regulation name: Appliance Fixation, Spinal Intervertebral Body Product Code: KWQ
Regulation number: 21 CFR 888.3040 Regulation name: Smooth or threaded metallic bone fixation fastener Product Code: HWC
PREDICATE DEVICES
MacroPore OS Spinal System K010911 MacroPore Hydrosorb Spine System K041105
CONFORMANCE WITH PERFORMANCE STANDARDS
No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.
1
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
Inion S-1™ Biodegradable Anterior Cervical Fusion System, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion rigit fixances (10), posterinain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.
Inion S-1 ™ Biodegradable Anterior Cervical Fusion System consist of cervical spinal fusion plates and screws, and is made of resorbable polylactic acid copolymers, P(L/DL)LA 80:20.
Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years.
Inion S-1 ™ Biodegradable Anterior Cervical Fusion System is provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.
SUBSTANTIAL EQUIVALENCE TO MARKETED PRODUCTS
Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion S-I TM Biodegradable Anterior Cervical Fusion System are substantially equivalent with the predicate devices MacroPore OS Spinal System (K010911) and MacroPore Hydrosorb Spine System (K041105).
Inion S-1 TM Biodegradable Anterior Cervical Fusion System is substantially equivalent to predicate Class II devices used in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring) in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts, because the differences between Inion S-1 ™ Biodegradable Anterior Cervical Fusion System and the predicate devices do not raise new questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 image of a human figure in profile, with its arms outstretched. The figure is composed of three curved lines that create the impression of movement and energy. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2008
Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Laakarinkatu 2 Tampere Finland 33520
Re: K051821
Trade/Device Name: Inion S-1™ Biodegradable Anterior Cervical Fusion System Regulation Number: 21 CFR 388.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: OJB Dated (Date on orig SE 1tr): November 25, 2005 Received (Date on orig SE ltr): November 25, 2005
Dear Ms. Marttinen:
This letter corrects our substantially equivalent letter of November 25, 2005.
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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings section of the device's labeling:
"The safety and effectiveness of this device, as an adjunct to fusion, when used without rigid supplemental internal fixation has not been established. This device is not designed to withstand physiologic loads when used by itself."
Furthermore, the indication for graft containment use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
3
Page 2 - Ms. Kati Marttinen
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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 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. 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 vours.
Sincerely, yours,
(Signature)
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K051821
Device Name:
Inion S-1"M Biodegradable Anterior Cervical Fusion System
Indications for Use:
INDICATIONS
The INION S-1™ BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.
CONTRAINDICATIONS
The INION S-1™ BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM implants are not intended for use in and are contraindicated for:
· Load bearing indications unless used in conjunction with traditional rigid fixation.
· Active or potential infection.
· Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse).
Yes Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
.............................................................................................................................................................................. .............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
Division of General, Restorative. and Neurological Devices
510(k) Number K051821