(36 days)
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.
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.
This document describes a 510(k) summary for the Cayman Thoracolumbar Plate System, Additional Sizes. This submission is for additional sizes of an existing device, and for such submissions, the primary focus is often on demonstrating that the new sizes meet the same performance criteria as the previously cleared device. Therefore, the information provided primarily pertains to mechanical testing rather than clinical studies or AI algorithm performance.
Here's an analysis of your questions based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static compression bending (in accordance with ASTM F1717) | Tested |
| Dynamic compression testing (in accordance with ASTM F1717) | Tested |
| Static torsion (in accordance with ASTM F1717) | Tested |
| Substantial equivalence to legally marketed devices | Considered substantially equivalent to other legally marketed devices based on similar design, material, and indications for use. Expected to be equivalent in safety and effectiveness. |
Note: The document states that the plates were "tested" in accordance with ASTM F1717, and are "considered substantially equivalent." It does not provide specific numerical results or predefined acceptance thresholds for these mechanical tests (e.g., a minimum strength or fatigue life). For medical devices like this, the "acceptance criteria" are often implicit in meeting a recognized standard (like ASTM F1717) and demonstrating performance comparable to predicate devices. The "reported device performance" is essentially that the tests were conducted and the device met the criteria for substantial equivalence to predicates.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a mechanical device (spinal plate system), not a diagnostic or AI-driven device. Therefore, a "test set" in the context of clinical data, AI algorithms, or human performance is not applicable here. The "test set" refers to the physical devices (additional sizes of the plates and screws) that underwent mechanical testing. The sample size for these mechanical tests is not specified in this summary.
Data Provenance: Not applicable in the context of clinical data. The "data" are the results of mechanical laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is cleared based on mechanical testing and substantial equivalence to predicate devices, not on human expert review of clinical data or image interpretation.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of clinical data requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI-assisted diagnostic tool or a device that impacts human reading performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a mechanical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
For this mechanical device, the "ground truth" implicitly refers to objective mechanical engineering standards (ASTM F1717) and comparison to the established performance of predicate devices. The "ground truth" is that the device, when subjected to specified loads and conditions, performs comparably to or within the acceptable limits defined by those standards and predicates.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI algorithm or clinical study for this mechanical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" or corresponding ground truth establishment process for this mechanical device.
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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 F1Leesburg, VA 20175 | Richard W. WoodsK2M, Inc.751 Miller Drive SE, Suite F1Leesburg, VA 20175Telephone: 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.
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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.
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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
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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.
§ 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.