(64 days)
The K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
The K2M Cervical Plate System is a spinal fixation system which consists of cervical 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 titanium alloy and nitinol, per ASTM and ISO standards. Function: The system functions as an adjunct to provide immobilization and stabilization of cervical segments of the spine.
The provided text describes a 510(k) premarket notification for a medical device, the K2M Cervical Plate System, Modifications. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and comparison of design, materials, and intended use. It does not contain information related to software performance, AI algorithms, clinical study data, or human reader performance. Therefore, most of the requested information cannot be extracted from this document.
However, I can extract information relevant to the device's performance based on the provided text, specifically related to its physical properties and mechanical testing.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance equal to or better than predicate devices in static torsion and dynamic compression testing per ASTM F1717. | The K2M implants performed equally to, or better than, these systems in static torsion and dynamic compression testing per ASTM F1717. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The testing refers to "K2M implants" and "these systems" (predicate systems), but the number of devices tested is not mentioned.
- Data Provenance: Not specified. The testing was conducted by or for K2M, Inc. (based in Leesburg, VA, USA), but the location where the tests were performed is not mentioned. It is a engineering/mechanical test, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a mechanical implant, and the "ground truth" for its performance is established through standardized mechanical testing (ASTM F1717), not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical test, not an assessment requiring adjudication by human experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a medical device (spinal plate system), not an AI or software-based diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective mechanical measurements against a recognized international standard (ASTM F1717) for static torsion and dynamic compression in comparison to predicate devices.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable (as above).
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JAN 1 7 2012
510(k) Summary for the K2M Cervical Plate System, Modifications
This safety and effectiveness summary for the Pyrenes Cerviced as required per Section 513(i)(3) of the Food. Drug and Cosmetic Act.
- Submitter : K2M, Inc. 751 Miller Drive SE. Leesburg, VA 20175 Contact Person : Nancy Giezen K2M. Inc. 751 Miller Drive SE Leesburg, VA 20175 Telephone: 703-777-3155
November 11, 2011 Date Prepared:
- Tradename: K2M Cervical Plate System 510(k), Modifications Common Name: Spinal Fixation System Classification Name: Spinal Intervertebral Body Fixation Orthosis (888.3060) Product Code: KWQ Device Class: l I
3. Predicate or legally marketed devices which are substantially equivalent :
4. Description of the device :
The K2M Cervical Plate System is a spinal fixation system which consists of cervical 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 titanium alloy and nitinol, per ASTM and ISO standards.
Function: The system functions as an adjunct to provide immobilization and stabilization of cervical segments of the spine.
5. Intended Use:
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis),
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :
The design features and sizing of the components were compared to predicate devices and the Pyrenees Cervical Plate System implants were found to be substantially the same as these devices. They are manufactured from the same materials (in accordance with ASTM F136 and ASTM F2063) and present with the same intended uses as these systems.
There are no significant differences between the K2M Cervical Plate systems currently being marketed. The K2M plates are substantially equivalent to these other devices in design, function, material and intended use.
7. Comparison of the performance characteristics of the device to predicate and legally marketed devices :
The K2M Cervical Plate System was mechanically tested and compared to the predicate systems and other currently marketed systems. The K2M implants performed equally to, or better than, these systems in static torsion and dynamic compression testing per ASTM F1717.
Therefore, the performance of the K2M Cervical Plate System is substantially equivalent to predicate devices.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 7 2012
K2M, Inc. % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175
Re: K113329
Trade/Device Name: K2M Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 20, 2011 Received: December 21, 2011
Dear Ms. Giezen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your so 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 commerce pror to May 20, 1977) in accordance with the provisions of the Federal Food. Drug, devices may have been room require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou mayy merelove, mains of the Act include requirements for annual registration, listing of Echerices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Trease noter - Survey, 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 your device 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 that I Dri has made a determinations administered by other Federal agencies. You must or any I catal statures and registments, including, but not limited to: registration and listing (21
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Page 2 - Ms. Nancy Giezen
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.
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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
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
KII 332 9
510(k) Number: Pending
Device Name: K2M Cervical Plate System, Modifications
Indications for Use:
The K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
K113329 510(k) Number_
Pg 1 of 1
§ 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.