(226 days)
Not Found
No
The device description and intended use focus on the physical components and function of a spinal implant system, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended for spinal fusion procedures to treat degenerative disc disease, tumors, or trauma/fracture, aiming to restore spinal integrity and achieve decompression, which are therapeutic interventions.
No
The device is described as an implantable spinal system intended for fusion and replacement procedures, not for diagnosing conditions. Its function is to provide structural support and stabilization.
No
The device description explicitly states it consists of PEEK spacers and titanium bone screws, which are physical hardware components, not software.
Based on the provided information, the Chesapeake Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The Chesapeake Spinal System is an implantable device used for spinal fusion and vertebral body replacement. It is surgically placed within the patient's body and does not involve the analysis of biological samples.
- The intended use and device description clearly define it as a surgical implant. The text describes its function in providing support and stabilization to the spine and replacing vertebral bodies.
- There is no mention of any diagnostic function. The device's purpose is structural support and fusion, not the diagnosis of a disease or condition through the analysis of biological samples.
Therefore, the Chesapeake Spinal System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Chesapeake implants are intended for spinal fusion procedures in skeletally mature patients who have had six months of non-operative treatment.
When used as intervertebral body fusion devices, the implants are indicated for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft.
When used as vertebral body replacement devices the Chesapeake implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Chesapeake implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The interior of the spacer may be packed with allograft or autograft.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP, OVD
Device Description
The Chesapeake Spinal System consists of PEEK spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads frods to be Grade UNS R05200, UNS R05400 according to ASTM F560. The screws are fabricated from Ti6Al4V per ASTM 1472.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, from L2 to S1, thoracolumbar spine (T1 to L5)
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)
Not Found
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.
K051454, K082698, K073109, K062083, K072253, K083475, K081501
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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KAZZII
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510(k) Summary Chesapeake Spinal System K2M, Inc.
This sales and effectiveness sumpary for the Aleutian IBP System is provided as required per Section 513((1)(3) of the Food, Drag and Cometio Act
- Submitter : K2M, Inc. 751 Miller Drive SE Suite F1 Leesburg, VA 20175
Date Prepared: January 28, 2010 Contact Person : Nancy Giezen K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155
MAR - 5 2010
- Tradename: Chesapeake Spinal System Intervertebral Body Fusion Device Common Name: Classification Name: Intervertebral Fusion Device (Product Code: MAX) Spinal Intervertebral Body Fixation Orthosis (Product Code: MQP) Regulation Number: 888.3080
3. Description of the device:
The Chesapeake Spinal System consists of PEEK spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads frods to be Grade UNS R05200, UNS R05400 according to ASTM F560. The screws are fabricated from Ti6Al4V per ASTM 1472.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
4. Intended Use:
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Chesapeake implants are intended for spinal firsion procedures in skeletally mature patients who have had six months of non-operative treatment.
When used as intervertebral body fusion devices, the implants are indicated for use level or two contiguous levels in the lumbar spine, from L2 to S1, for the treament of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft.
When used as vertebral body replacement devices the Chesapeake implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or traums/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Chesapeake implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The interior of the spacer may be packed with allograft or autograft.
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S. Predicate or legally marketed devices which are substantially equivalent:
Documentation was provided which demonstrated that the subject Chesapeake Spinal System components are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501).
- Comparison of the technological characteristics of the device to predicate and legally marketed devices:
There are no significant differences between the Chesapeake Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
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V J2721
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
K2M, Inc. % Mr. Richard Woods 751 Miller Drive SE, Suite F1 Leesburg, VA 20175
SEP 12 2011
Re: K092211
Trade/Device Name: Chesapeake Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MOP Dated: January 29, 2010 Received: February 1, 2010
Dear Mr. Woods:
This letter corrects our substantially equivalent letter of March 5, 2010.
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 (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
3
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Melleusen
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): dog 221 (
Device Name : Chesapeake Spinal System
Indications For Use :
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Chesapeake implants are intended for spinal fusion procedures in skeletally mature patients who have had six months of non-operative treatment.
When used as intervertebral body fusion devices, the implants are indicated for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative dise disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft.
When used as vertebral body replacement devices the Chesapeake implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectorny) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Chesapeake implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The interior of the spacer may be packed with allograft or autograft.
Prescription use X
OR
Over-the-counter use ( PER 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation ( ODE )
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KO92211 510(k) Number_