(165 days)
Not Found
No
The description focuses on the mechanical design and materials of a spinal implant, with no mention of AI or ML capabilities. Performance studies are based on mechanical testing (FEA) and comparison to predicate devices.
Yes
The description explicitly states its indication for interbody fusion in patients with degenerative disc disease, which is a therapeutic intervention.
No.
The device is an intervertebral body fusion device and is used for treatment (spinal fusion), not for diagnosis. Its intended use states it is for patients with confirmed DDD and is to be used with bone graft and supplemental fixation instrumentation.
No
The device description clearly states it is a physical implant made of titanium alloy, designed to be surgically placed in the spine. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The CRESCENT® Spinal System Titanium is a surgical implant designed to be placed within the body (specifically, the lumbar spine) to facilitate bone fusion. Its purpose is structural support and to hold bone graft material, not to analyze biological specimens.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological samples, chemical reactions, or diagnostic testing. The device is a physical implant.
Therefore, based on the provided information, the CRESCENT® Spinal System Titanium is a medical device, specifically a surgical implant, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CRESCENT® Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The CRESCENT® Spinal System Titanium is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation.
The CRESCENT® Spinal System Titanium consists of a variety of hollow intervertebral body spacers featuring a bullet nosed, anatomically shaped design with axial voids designed to hold bone graft material. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The subject devices are manufactured from anodized medical grade titanium alloy (Ti-6Al-4V).
The purpose of this submission is to add CRESCENT® Spinal System Titanium intervertebral body fusion devices to the CRESCENT® Spinal System family.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2 to S1
Indicated Patient Age Range
skeletally mature
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 subject Intervertebral Body Fusion Devices were tested using Finite Element Analysis (FEA) and confirmatory supplemental testing in accordance with ASTM F2077 and ASTM F2267. This testing was compared to previously listed predicate devices. The subject devices met the predetermined acceptance criteria for all tests. Tests results were provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CRESCENT® Spinal System K094025, LT-CAGE® Titanium Lumbar Tapered Fusion Device P9710015/S010, CLYDESDALE® Spinal System K100175, CAPSTONE® Spinal System K073291
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
KII0543
CRESCENT® Spinal System Titanium 510(k) Summary July 2011
AUG - 9 2011
| I. COMPANY: | Medtronic Sofamor Danek USA
1800 Pyramid Place
Memphis, Tennessee 38132 |
|------------------------------------------|---------------------------------------------------------------------------------------------------|
| II. CONTACT: | Becky Ronner
Regulatory Affairs Specialist
Telephone: (901) 399-2757
Fax: (901) 346-9738 |
| III. PROPOSED PROPRIETARY
TRADE NAME: | CRESCENT® Spinal System
Titanium |
| IV. CLASSIFICATION NAMES: | Intervertebral Body Fusion Device |
| CLASS: | II |
| PRODUCT CODE: | MAX (21 CFR 888.3080) |
| V. PRODUCT DESCRIPTION: | |
The CRESCENT® Spinal System Titanium is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation.
The CRESCENT® Spinal System Titanium consists of a variety of hollow intervertebral body spacers featuring a bullet nosed, anatomically shaped design with axial voids designed to hold bone graft material. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The subject devices are manufactured from anodized medical grade titanium alloy (Ti-6Al-4V).
The purpose of this submission is to add CRESCENT® Spinal System Titanium intervertebral body fusion devices to the CRESCENT® Spinal System family.
VI. INDICATIONS FOR USE:
The CRESCENT® Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined
1
as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
VII. Summary of the Technological Characteristics:
The purpose of this Special 510(k) submission is to include Titanium Alloy Intervertebral body Fusion Device into the CRESCENT® Spinal System family. The current CRESCENT® Spinal System is offered in polyetheretherketone (PEEK) material. The design is essentially the same fundamental technology with minor dimensional changes.
VIII. Identification of Legally Marketed Devices:
The design features and indications for use for the subject CRESCENT® Spinal System Titanium are substantially equivalent to the following predicates:
- · CRESCENT® Spinal System K094025
- " LT-CAGE® Titanium Lumbar Tapered Fusion Device P9710015/S010
- · CLYDESDALE® Spinal System K100175
- · CAPSTONE® Spinal System K073291
IX. Discussion of Non-Clinical Testing:
The subject Intervertebral Body Fusion Devices were tested using Finite Element Analysis (FEA) and confirmatory supplemental testing in accordance with ASTM F2077 and ASTM F2267. This testing was compared to previously listed predicate devices. The subject devices met the predetermined acceptance criteria for all tests. Tests results were provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.
X. Conclusion:
A risk analysis was completed, non-clinical validated FEA simulated testing was performed and confirmatory supplemental testing in accordance with ASTM F2077 and ASTM F2267. Based on the test results and additional supporting documentation provided in this premarket notification, the subject devices demonstrated substantial equivalence to listed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Medtronic Sofamor Danek USA % Ms. Becky Ronner Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
AUG - 9 2911
Re: K110543
Trade/Device Name: Crescent Spinal System Titanium Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 05, 2011 Received: July 11, 2011
Dear Ms. Ronner:
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
3
Page 2 - Ms. Becky Ronner
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.
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/ReportalProblem/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 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): _KII 0543
Device Name: CRESCENT® Spinal System Titanium
Indications for Use:
The CRESCENT® Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________