(155 days)
Not Found
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as providing "stabilization as an adjunct to cervical fusion" and is indicated for conditions like "degenerative disc disease", "spondylolisthesis", "trauma", and "spinal stenosis", which are therapeutic interventions.
No
This device is a cervical plate system used for stabilization in fusion surgeries, not for diagnosing medical conditions. It is a therapy device.
No
The device description explicitly states that the system comprises "plate and screw components in a variety of sizes and lengths," which are physical hardware implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states this is a "Cervical Plate System" comprising "plate and screw components." These are implants designed for surgical fixation within the body.
- Intended Use: The intended use is for "anterior screw fixation of the cervical spine" and "stabilization as an adjunct to cervical fusion." This is a surgical procedure performed on the patient.
While the intended use mentions "radiographic studies" for diagnosis, the device itself is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is not intended for screw attachment or 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 Precision Surgery Limited Fixed, Variable & Corpectomy Cervical Plate System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Documentation was provided which demonstrated the Precision Surgery Limited Fixed, Variable & Corpectomy Cervical Plate System to be substantially equivalent to the previously cleared Fixed & Variable Cervical Plate System. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites and performance.
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.
Not Found
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
JUN - 3 2008
:
510(k) Summary
Sponsor:
| Sponsor: | Precision Surgery Limited
2700 W Ninth Ave, Suite 120
Oshkosh WI 54904
Phone: 920.223.0547
Facsimile: 920.223.0551 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kamaliit S. Paul, MD |
| Proposed Trade Name: | Fixed, Variable & Corpectomy Cervical Plate System |
| Classification: | Class II |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Regulation: | 888.3060 |
| Device Product Code: | KWQ |
| Device Description: | The Precision Surgery Limited Fixed, Variable & Corpectomy Cervical
Plate System comprises plate and screw components in a variety of sizes
and lengths. Three styles of plate, including fixed, variable and corpectomy,
are available. Primary, self-drilling primary and rescue screws are offered. |
| Intended Use: | The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical
Plate System is intended for anterior screw fixation of the cervical spine.
These implants have been designed to provide stabilization as an adjunct to
cervical fusion. Indications for the use of this implant system include
degenerative disc disease defined as neck pain of discogenic origin with the
degeneration of the disc confirmed by history and radiographic studies,
spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis
or failed previous fusion.
WARNING: The Precision Surgery Limited Fixed, Variable and
Corpectomy Cervical Plate System is not intended for screw attachment or
fixation to the posterior elements (pedicles) of the cervical, thoracic or
lumbar spine. |
| Materials: | The Precision Surgery Limited Fixed, Variable & Corpectomy Cervical
Plate System components are manufactured from titanium alloy (Ti-6A1-4V
per ASTM F136). The screw-retaining central rail is manufactured from
nickel titanium alloy (NiTi per ASTM F2063). |
| Substantial
Equivalence: | Documentation was provided which demonstrated the Precision Surgery
Limited Fixed, Variable & Corpectomy Cervical Plate System to be
substantially equivalent to the previously cleared Fixed & Variable Cervical
Plate System. The substantial equivalence is based upon equivalence in
basic design, intended use, indications, anatomic sites and performance. |
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Precision Surgery Limited % Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141
JUN - 3 2008
Re: K073708
Trade/Device Name: Fixed, Variable & Corpectomy Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 05, 2008 Received: May 06, 2008
Dear Dr. Warden:
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.
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.
2
Page 2 - Karen E. Warden, Ph.D.
This letter will allow you to begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: K073708
Device Name: Fixed, Variable & Corpectomy Cervical Plate System
Indications for Use:
The Precision Surgery Limited Fixed, Variable and Corpectorny Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusions for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use (Per 21 CFR 801.109)
NEEDED)
OR Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogle for mxn
Division of General, Restorative, and Neurological Devices
510(k) Number K073708