(202 days)
None
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is indicated for spinal fusion procedures to treat degenerative disc disease, which involves mitigating a medical condition.
No
The device is a Cervical Stand Alone System designed for spinal fusion procedures. Its purpose is to provide structural stability and is used with autograft bone material and screws to aid in fusion, not to diagnose a condition.
No
The device description clearly states it is a physical implant made from PEEK and Titanium with Titanium bone screws, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal fusion procedures in the cervical spine. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (spacer and screws) designed to provide structural stability and facilitate bone fusion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples from the body. This device is a therapeutic implant used in a surgical procedure.
N/A
Intended Use / Indications for Use
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD), DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft bone material and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Product codes
OVE
Device Description
The Cervical Stand Alone device is a stand-alone spacer system designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The Cervical Stand Alone spacer is manufactured from PEEK and Titanium with Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior suffaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
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 testing consisting of Static and Dynamic Axial Compression Test, Static and Dynamic Torsion Test, Static and Dynamic Compression Shear Test, Subsidence Test and Expulsion Test were conducted in accordance to ASTM F2077-11 standard for Test Method for Intervertebral Body Fusion Devices, ASTM F2267-04 standard for Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression and in accordance with ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Method for Intervertebral Body Fusion Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101812, K091088, K083389, K102606
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
510(k) SUMMARY
Cervical Stand Alone System
APR 1 4 2014
510(k) Owner Information
| Name:
Address: | Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214.937.2145
214-937-3322
nataliavolosen@orthofix.com |
| Registration Number: | 3008524126 |
| Contact Person: | Natalia Volosen
Senior Regulatory Affairs Specialist |
| Date Prepared: | April, 10, 2014 |
| Name of Device
Trade Name / Proprietary
Name: | Cervical Stand Alone System |
| Common Name: | Intervertebral body fusion device |
| Product Code: | OVE - Cervical intervertebral fusion device with integrated fixation |
| Regulatory Classification: | Class II - 21 CFR § 888.3080 - Intervertebral body fusion device |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K101812 - CONSTRUX Mini PEEK Spacer System, SE 9/27/10
K091088 - LDR Spine Cervical Interbody Fusion System, SE
07/14/09
K083389 - COALITION Spacer, SE 03/26/09
K102606 - AVS Anchor-C Cervical Cage System, SE 04/22/11 |
Reason for 510(k) Submission: New product offering
Device Description
The Cervical Stand Alone device is a stand-alone spacer system designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The Cervical Stand Alone spacer is manufactured from PEEK and Titanium with Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior suffaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.
1
Intended Use / Indications for Use
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD), DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft bone material and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the Cervical Stand Alone System are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Mechanical testing consisting of Static and Dynamic Axial Compression Test, Static and Dynamic Torsion Test, Static and Dynamic Compression Shear Test, Subsidence Test and Expulsion Test were conducted in accordance to ASTM F2077-11 standard for Test Method for Intervertebral Body Fusion Devices, ASTM F2267-04 standard for Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression and in accordance with ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Method for Intervertebral Body Fusion Devices.
Basis of Substantial Equivalence
The new Cervical Stand Alone system has the same intended use, similar indications for use. the same technological characteristics and design, same materials and the same principles of operation as the to the AVS Anchor-C Cervical Cage System. CONSTRUX Mini PEEK Spacer svstem. COALITION Spacer and LDR Spine Cervical Interbody Fusion System device.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2014
Orthofix, Incorporated Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K132999
Trade/Device Name: Cervical Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II · Product Code: OVE Dated: March 6, 2014 Received: March 7, 2014
Dear Ms. Volosen:
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 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
3
Page 2 – Ms. Natalia Volosen
forth in the quality systems (OS) 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 . contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDeviccs/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K132999
Device Name
Cervical Stand Alone System
Indications for Use (Describe)
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-11), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft bone material and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regiment of at 16) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY 46. . . ..... :"
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev. Ph
Division
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