(36 days)
Not Found
No
The summary describes a mechanical spinal fixation system made of titanium, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a spinal fixation system intended to provide temporary stabilization during fusion for various acute and chronic instabilities and deformities of the thoracolumbar spine, which directly treats medical conditions.
No
The Cayman Thoracolumbar Plate System is described as a spinal fixation system, intended to provide temporary stabilization during fusion, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of "screws and plates" and is manufactured from "CP Titanium and Ti6Al4V," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for stabilizing the spine during fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a spinal fixation system consisting of screws and plates made of titanium. This is consistent with a surgical implant.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical testing (compression, torsion) relevant to the structural integrity of a surgical implant, not on diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is implanted in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L1-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
Product codes
KWO
Device Description
The Cayman Thoracolumbar Plate System is a spinal fixation system which consists of screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (T1-L5) spine, lumbosacral level below the bifurcation of the vascular structures (L1-S1)
Indicated Patient Age Range
skeletally mature patients
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)
The Cayman Thoracolumbar Plates were tested in static compression bending, dynamic compression testing and static torsion in accordance with ASTM F1717 and are considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081380, K043548, K020244, K013665, K922543, K080773, K072407
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
JUN - 4.2009
KU91253
510(k) SUMMARY
for the
Cayman Thoracolumbar Plate System, Additional Sizes
This safety and effectiveness summary for the Cayman Thoracolumbar Plate System is provided as required per Section 513(Y(3) of the Food. Drug and Cosmetic Act.
| 1. Submitter : | Contact Person : |
|---|---|
| K2M, Inc. | |
| 751 Miller Drive SE, | |
| Suite F1 | |
| Leesburg, VA 20175 | Richard W. Woods |
| K2M, Inc. | |
| 751 Miller Drive SE, Suite F1 | |
| Leesburg, VA 20175 | |
| Telephone: 703-777-3155 | |
| Date Prepared: | April 28, 2009 |
| 2. Tradename: | Cayman Thoracolumbar Plate System |
|---|---|
| Common Name: | Thoracolumbar Plates |
| Classification Name: | Spinal intervertebral body fixation orthosis (21 CFR 888.3060) |
3. Predicate or legally marketed devices which are substantially equivalent :
- K2M Cayman Thoracolumbar Plate System, K081380 .
- Blackstone Medical Unity Anterior Lumbar Plate Fixation System, K043548 .
- Synthes Thoracolumbar Spine Locking Plate. K020244 ◆
- Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System, K013665 .
- Sofamor Danek Z-Plate, K922543 .
- Stryker Thor Anterior Plating System, K080773 .
- Theken BodyForm Thoracic Fixation System, K072407 .
4. Description of the device:
The Cayman Thoracolumbar Plate System is a spinal fixation system which consists of screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the spine.
5. Intended Use:
The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LI-$1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
6. Technological and Performance Characteristics:
The Cayman Thoracolumbar Plates were tested in static compression bending, dynamic compression testing and static torsion in accordance with ASTM F1717 and are considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness.
1
Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the circle is an image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K2M, Inc. % Mr. Richard W. Woods 751 Miller Drive, S.E. Suite F1 Leesburg, Virginia 20175
JUN - 4 2009
Re: K091253
Trade/Device Name: Cayman Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: April 28, 2009 Received: May 5, 2009
Dear Mr. Woods:
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 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 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 - Mr. Richard W. Woods
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K091253
Device Name: Cayman Thoracolumbar Plate System
Indications for Use:
The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L1-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, i) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
Prescription Use X (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)
Sof (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number.