(89 days)
Not Found
No
The document describes a physical implant for spinal fusion and replacement, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is used to replace vertebral bodies and aid in spinal fusion, which are therapeutic interventions aimed at restoring function and alleviating symptoms.
No
The document describes the Cimplicity System as an implant used to replace vertebral bodies and for interbody fusion, not to diagnose medical conditions. Its purpose is restoration and stabilization, not detection or analysis of diseases.
No
The device description clearly states that Cimplicity is a "rectangular shaped implant" with "teeth on the superior and inferior surface," indicating it is a physical hardware device intended for surgical implantation, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace or fuse vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant with specific shapes and features for surgical placement. This is consistent with a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing and substantial equivalence to predicate devices, which are typical for surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cimplicity System does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. These devices 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. These devices are intended to be used with autograft or allograft bone.
When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with a Cimplicity interbody fusion device.
Product codes
MQP, ODP
Device Description
Cimplicity is a rectangular shaped implant, which is available in a parallel or lordotic configuration of various heights. Cimplicity is hollow to allow for the placement of allograft or autograft bone. There vare teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from T1 to L5), cervical (C2-C3 disc to the C7-TI disc)
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)
Mechanical test results demonstrate that the proposed Cimplicity System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SpineSmith Cimplicity Spinal System (K073320), LDR Spine MC+ (K043479), Spinal Elements, Inc. Crystal (K073351)
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
K080971 (pg. 1 of 2)
JUL - 2 2008
SpineSmith Cimplicity Spinal System
510(k) Summary of Safety and Effectiveness
| SUBMITTED BY | SpineSmith Partners, LP
8140 N. Mopac, Bldg II, Suite 120
Austin, TX 78759 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 3006404071 |
| CONTACT PERSON | Robert Jones
Vice President, Research and Development
Phone: 512-206-0770
Fax: 512-637-6750
Email: rjones@spinesmithusa.com |
| SUBMISSION PREPARED BY | Lisa Peterson
Kaedon Consulting, LLC
Phone: 512-507-0746 |
| DATE PREPARED | April 2, 2008 |
| CLASSIFICATION | MQP 888.3060- Spinal Intervertebral Body Fixation
Orthosis
ODP 888.3080 - Intervertebral fusion device with bone graft,
cervical |
| COMMON NAME | Spinal Vertebral Body Replacement System (MQP)
Intervertebral body fusion device (ODP) |
| PROPRIETARY NAME | SpineSmith Cimplicity Spinal System |
| PREDICATE DEVICE(S) | SpineSmith Cimplicity Spinal System (K073320)
LDR Spine MC+ (K043479)
Spinal Elements, Inc. Crystal (K073351) |
| SUBSTANTIAL
EQUIVALENCE | The SpineSmith Cimplicity System was determined to be
substantially equivalent to several commercially available
systems. |
DEVICE DESCRIPTION
Cimplicity is a rectangular shaped implant, which is available in a parallel or lordotic configuration of various heights. Cimplicity is hollow to allow for the placement of allograft or autograft bone. There vare teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.
1
INDICATIONS:
The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. These devices 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. These devices are intended to be used with autograft or allograft bone.
When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach.
MECHANICAL TEST DATA
Mechanical test results demonstrate that the proposed Cimplicity System is substantially equivalent to the predicate device.
2
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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spine Smith Partners % Mr. Robert Jones Vice President, Research and Development 8140 North Mopac Building II, Suite 120 Austin, TX 78759
K080971 Re:
Trade/Device Name: Cimplicity Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal vertebral body fixation device Regulatory Class: II Product Code: MQP, ODP Dated: April 2, 2008 Received: April 4, 2008
Dear Mr. Jones:
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 such 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); 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.
JUL - 2 2008
3
Page 2 - Mr. Robert Jones
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K080971
Device Name:
SpineSmith Partners, LP Cimplicity System
Indications for Use:
The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from TI to LS) and is intended for use with supplemental internal fixation. These devices 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. These devices are intended to be used with autograft or allograft bone,
When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity imvlants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with a Cimplicity interbody fusion device.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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 General, Restorative, |
| and Neurological Devices |
| 510(k) Number | L08091 |
|---|---|
| --------------- | -------- |