(153 days)
Not Found
No
The description focuses on the mechanical properties and materials of a spinal plate system, with no mention of AI or ML capabilities.
No
The device provides temporary stability until fixation is achieved, rather than treating a disease or condition itself.
No
The device description indicates that the CoreLink ZOU™ Anterior Lumbar Plate System is a medical implant designed to provide temporary stability to the spine during intervertebral fusion, rather than to diagnose medical conditions.
No
The device description explicitly states it is comprised of titanium alloy plates and screws, which are hardware components, not software.
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, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (plates and screws made of titanium alloy) used to stabilize the spine during fusion. This is a physical device implanted within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's a "supplemental fixation device" for surgical procedures on the lumbar spine. This is a therapeutic and structural function, not a diagnostic one.
Therefore, based on the provided information, the CoreLink ZOU™ Anterior Lumbar Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CoreLink ZOUTM Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterior lateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels.
The CoreLink ZOU™ Anterior Lumbar Plate System is designed to provide temporary stability until fixation is achieved. It is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Zou® Anterior Lumbar Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Zou® Anterior Lumbar Plate System is manufactured from Ti-6A1-4V ELI in accordance with ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior lumbar (L1-S1)
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)
Testing performed on this device indicates that the Zou® Anterior Lumbar Plate System is substantially equivalent to predicate devices. A modified ASTM F1717 test protocol was adhered to and all substantial equivalence requirements were met. This testing included static compression bending, static torsion, and dynamic compression bending.
The Zou® Anterior Lumbar Plate System is substantially equivalent to predicate devices with respect to safety and effectiveness.
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.
K091044, K082187, K061353, K022791, K052546
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
510(k) Summary
| Contact: | Justin Eggleton
Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800 | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date Prepared: | November 16, 2012 | |
| Device Trade Name: | Zou® Anterior Lumbar Plate System | |
| Manufacturer: | CoreLink, LLC
10805 Sunset Office Drive, Suite 300
St. Louis, MO 63127 | |
| Common Name: | Spinal Fixation Device | |
| Classification: | 21 CFR §888.3060; Spinal intervertebral fixation orthosis | |
| Class: | II | |
| Product Code: | KWQ | |
Indications For Use:
The CoreLink ZOUTM Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterior lateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels.
The CoreLink ZOU™ Anterior Lumbar Plate System is designed to provide temporary stability until fixation is achieved. It is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Description:
The Zou® Anterior Lumbar Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Zou® Anterior Lumbar Plate System is manufactured from Ti-6A1-4V ELI in accordance with ASTM F136.
Pg 1 of 2
NOV 1 9 am
K12199
1
Predicate Device(s):
The Zou® Anterior Lumbar Plate System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These devices include the Spinal USA AccuFit Anterior Lumbar Plate System (K091044). Biomet Valiant Anterior Lumbar Plate System (K082187), Zimmer Trinica Anterior Lumbar Plate System (K061353), Synthes Anterior Tension Band System (K022791), and DePuy Aegis Anterior Lumbar Plate System (K052546).
Performance Standards:
Testing performed on this device indicates that the Zou® Anterior Lumbar Plate System is substantially equivalent to predicate devices. A modified ASTM F1717 test protocol was adhered to and all substantial equivalence requirements were met. This testing included static compression bending, static torsion, and dynamic compression bending.
Conclusion:
The Zou® Anterior Lumbar Plate System is substantially equivalent to predicate devices with respect to safety and effectiveness.
Rg Zodz
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Corelink, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street, 12th Floor Washington, District of Columbia 20005
Re: K121791
Trade/Device Name: Zou® Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 31, 2012 Received: November 01, 2012
Dear Mr. Eggleton:
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
Letter Dated: November 19, 2012
3
Page 2 - Mr. Justin Eggleton
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 forth in the quality systems (OS) 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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Zou® Anterior Lumbar Plate System
The CoreLink ZOU™ Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterior lateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels.
The CoreLink ZOUTM Anterior Lumbar Plate System is designed to provide temporary stability until fixation is achieved. It is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number K121791