(168 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a spinal fixation system intended to provide temporary stabilization during spinal fusion procedures, which aims to treat various spinal conditions like degenerative disc disease, fractures, and deformities. These are all therapeutic actions.
No
The device is described as a spinal fixation system that provides temporary stabilization during fusion procedures, not for diagnosing 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. The function is described as providing "immobilization of the spine," which is a mechanical function performed by physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the CAYMAN Plate System is a spinal fixation system consisting of screws and plates intended for use in spinal fusion procedures to maintain the relative position of bony tissue. It is an implantable device used directly within the body during surgery.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to test samples from the body or to provide diagnostic information based on such tests.
Therefore, the CAYMAN Plate System falls under the category of surgical implants or fixation devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and 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 (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of 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, t) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, i) deformity (i.e., scoliosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
Product codes
KWQ
Device Description
The Cayman 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 more closely match 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.
The purpose of this submission is to add minimally invasive (MI) plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and thoracolumbar (TI-L5) spine, lumbosacral level below the bifurcation of the vascular structures (LS-St )
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 previously tested in static compression bending, dynamic compression testing and static torsion and were considered substantially equivalent to other legally marketed devices. Additional ASTM F1717 testing determined that the proposed MI plates do not represent a new worst case. They are similar in design, material, and indications for use to predicate plates and are expected to be equivalent in safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081380, K091253, K100061, K052546, K972718, K922543
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 0 9 2013
510(k) SUMMARY Cayman MI Plates K2M, Inc.
- Submitter :
K2M, Inc. 751 Miller Drive SE, Leesburg. VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155
Date Prepared: October 16, 2013
- Tradename: Cayman Plate System Common Name: Thoracolumbar Plates Classification Name: Spinal intervertebral body fixation orthosis (21 CFR 888.3060) Product Code: KWQ
3. Predicate or legally marketed devices which are substantially equivalent :
- K2M Cayman Plate System, K081380, K091253, K100061 .
- . DePuy Aegis, K052546
- DePuy M2, K972718 .
- . Sofamor Danek. Z-Plate, K922543
4. Description of the device:
The Cayman 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 more closely match 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.
The purpose of this submission is to add minimally invasive (MI) plates.
5. Intended Use:
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (TI-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LS-St ). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph 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 previously tested in static compression bending, dynamic compression testing and static torsion and were considered substantially equivalent to other legally marketed devices. Additional ASTM F1717 testing determined that the proposed MI plates do not represent a new worst case. They are similar in design, material, and indications for use to predicate plates and are expected to be equivalent in safety and effectiveness.
1
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 9, 2013
K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive, Southeast, Suite F1 Leesburg, Virginia 20175
Re: K131533
Trade/Device Name: Cayman Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 17, 2013 Received: October 18, 2013
Dear Ms. Giezen:
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
2
Page 2 - Ms. Nancy Giezen
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Erini Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K131533
Device Name: Cayman Thoracolumbar Plate System
Indications for Use:
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and 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 (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of 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, t) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, i) deformity (i.e., scoliosis, 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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices