(84 days)
Not Found
No
The document describes a mechanical implant system for spinal stabilization and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is intended for the treatment of cervical spinal instability resulting from various medical conditions, indicating a therapeutic purpose.
No
This device is a surgical implant (a cervical plating system) used for spinal fixation and is not described as being used to diagnose conditions.
No
The device description explicitly states that the device consists of physical components (plate, screws, and instruments) made from Titanium Alloy/Phynox. It is a hardware-based implant system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Quintex Cervical Plating System is a surgical implant used to stabilize the cervical spine. It is a physical device implanted into the body to treat structural issues.
- No Mention of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens.
Therefore, the Quintex Cervical Plating System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:
- Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis, .
- Trauma (i.e. fracture or dislocation), .
- Spinal Stenosis, ●
- Deformity (i.e., scoliosis, kyphosis, and/or lordosis), ●
- Tumors, ●
- Pseudoarthrosis as a result of failed spine surgery, .
- Failed previous fusions, .
- Symptomatic cervical spondylosis .
- Instability following surgery for the above indications. .
Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS Cervical Plating System is manufactured from Titanium Alloy/Phynox and will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2-T1
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)
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate the Quintex Cervical Plaing System is substantially equivalent to the predicate device. The following testing was performed:
- Off axis screw insertion .
- Redirection of screw trajectory .
- . Intentional Pry Out
The results of these tests showed that the subject device meets or exceed the performance of the predicate device, and the device is therefore found to be substantially equivalent.
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
§ 888.3060 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
121801
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B. Quintex Cervical Plating System SEP 1 1 2012 August 20, 2012 COMPANY: Aesculap Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311 CONTACT: Lisa M. Boyle 800-258-1946 (phone) 610-791-6882 (fax) TRADE NAME: Quintex Cervical Plating System COMMON NAME: Anterior Cervical Screw Spinal Fixation System CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis (87KWQ)
REGULATION NUMBER: 888.3060
PURPOSE FOR PREMARKET NOTIFICATION
The Quintex Cervical Plating System described in this submission represents minor changes implemented to the Quintex screw and screwdriver.
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems (AIS), Inc., believes that the modifications to Quintex Cervical Plating System is substantially equivalent to the AIS Quintex Cervical Plating System (K100243).
DEVICE DESCRIPTION
The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS Cervical Plating System is manufactured from Titanium Alloy/Phynox and will be provided non-sterile.
INDICATIONS FOR USE
The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:
- . Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis, .
- Trauma (i.e. fracture or dislocation), .
1
- Spinal Stenosis.
- Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
- . Tumors.
- . Pseudoarthrosis as a result of failed spine surgery,
- Failed previous fusions, ●
- Symptomatic cervical spondylosis, ●
- Instability following surgery for the above indications. .
Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)}
The AIS Quintex Cervical Plating System remains substantially equivalent to current Quintex Cervical Plating System (K100243). Biomechanical testing of the subject device was found to be similar in performance to previously cleared system.
PERFORMANCE DATA
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate the Quintex Cervical Plaing System is substantially equivalent to the predicate device. The following testing was performed:
- Off axis screw insertion .
- Redirection of screw trajectory .
- . Intentional Pry Out
The results of these tests showed that the subject device meets or exceed the performance of the predicate device, and the device is therefore found to be substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems, LLC. % Ms. Lisa Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
SEP 11 2012
Re: K121801
Trade/Device Name: Quintex Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 24, 2012 Received: August 27, 2012
Dear Ms. Boyle:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Lisa Boyle
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/CDRH0ffices/ucm115809.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.
yours,
Ron
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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Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
2121801 510(k) Number:
Device Name: Quintex Cervical Plating System
Indications for Use:
The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:
- Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis, .
- Trauma (i.e. fracture or dislocation), .
- Spinal Stenosis, ●
- Deformity (i.e., scoliosis, kyphosis, and/or lordosis), ●
- Tumors, ●
- Pseudoarthrosis as a result of failed spine surgery, .
- Failed previous fusions, .
- Symptomatic cervical spondylosis .
- Instability following surgery for the above indications. .
Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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)
Concur
Carl- Rf-
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number k/2/80/
002