(112 days)
Not Found
No
The device description explicitly states that the system does not contain software/firmware, and there are no mentions of AI, DNN, or ML in the document.
Yes
This device is intended for spinal fusion procedures to treat degenerative disease of the cervical spine, which is a medical condition. Therefore, it is a therapeutic device.
No
The device is an intervertebral spacer intended for spinal fusion procedures, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states, "The system does not contain software/firmware." Additionally, the device is a physical implant made of PEEK and tantalum, intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Calix-C™ Cervical Interbody Spacer is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion. It does not analyze or test biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
The device description and performance studies also focus on the mechanical properties and surgical application of the implant, further confirming it is not an IVD.
N/A
Intended Use / Indications for Use
The Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment with the Calix-C™ Cervical Interbody Spacer.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., posterior cervical screw and rod systems and anterior cervical plate systems).
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Calix-C™ Cervical Interbody Spacer is an intervertebral fusion device, generally box or oval-shaped, that has various holes throughout its geometry. The device body is made from Invibio PEEK-Optima™ (polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560. Superior and inferior surfaces of the device have teeth to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without titanium plasma coating on the superior and inferior surfaces of the device. The plasma coating is made from medicalgrade titanium per ASTM F1580. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The system does not contain software/firmware.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, one level (C2 - T1 inclusive)
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 is recommended in the FDA special controls guidance document, "Class II Special Controls Guidance: Intervertebral Body Fusion Device". X-spine has previously submitted to the FDA results of performance testing for Calix cervical implants: K112036 and K083637, according to the following standards:
- ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices:
- Static and dynamic torsion testing
- Static and dynamic axial compression and compression shear testing
- ASTM F 2267-04 Test Methods for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- Expulsion testing as recommended by FDA
- ASTM F 1580 -- Performance Qualification of Commercially Pure Titanium Plasma Spray (CP Ti)
Therefore, no new nonclinical testing was performed for the purpose of this submission.
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.
K112036, K143578, K160528, K152532, K151064
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
X-Spine Systems, Inc. Mr. Kriss Andersson Director, Regulatory Affairs 452 Alexandersville Road Miamisburg, Ohio 45342
August 1, 2017
Re: K171075
Trade/Device Name: Calix-CTM Cervical Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 2, 2017 Received: May 4, 2017
Dear Mr. Andersson:
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
1
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 contact the Division of Industry and Consumer Education at its toll-free 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known)
Device Name
Calix-CTM Cervical Interbody Spacer
Indications for Use (Describe)
The Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment with the Calix-CTM Cervical Interbody Spacer.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., posterior cervical screw and rod systems and anterior cervical plate systems).
| Type of Use (Select one or both , as applicable) |
|---|
| --------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY (21 CFR 807.92)
Calix-C™ Cervical Interbody Spacer
| I. | SUBMITTER/MANUFACTURER: | X-spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg, OH 45342 |
|------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | | Telephone (937) 847-8400
FAX (937) 847-8410 |
| | | Establishment Registration Number: 3005031160 |
| | Official Contact: | Mr. Kriss Anderson
Director, Regulatory Affairs
Email: kanderson@X-spine.com
Telephone (937) 847-8400, ext. 2137 |
| II. | DATE PREPARED: | May 2, 2017 |
| III. | OWNER/OPERATOR: | Xtant Medical Inc.
604 Cruiser Lane
Belgrade, MT 59714 |
| | Owner/Operator Number: | 10028385 |
| | Official Correspondent: | Stephen Smith, Vice President
Regulatory Assurance/ Quality Assurance
Xtant Medical, Inc.
Telephone (406) 388-0480 |
| IV. | DEVICE | |
| | Trade/Proprietary Name: | Calix-C™ Cervical Interbody Spacer |
| | Device Common Name: | Intervertebral Body Fusion Device |
| | Regulation Number: | 21 CFR §888.3080 |
| | Product Code: | ODP -- Intervertebral body fusion device
with Bone Graft, Cervical |
| | Regulatory Class: | Class II with Special Controls |
| | Review Panel: | Orthopedic |
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V. PURPOSE OF THE SUBMISSION
The purpose for this submission is to add additional sizes of Calix implants to the system, now known as Calix-C™ Cervical Interbody Spacer and to expand the Indications for Use.
VI. PREDICATE DEVICES
- Primary: X-spine, Inc.: Calix PC™ Spinal Implant System -- K112036
- Additional: Globus Medical, Inc.: PATRIOT® Cervical Spacers, (including COLONIAL® and COLONIAL® TPS) -- K143578
- Medtronic Sofamor Danek USA, Inc.: ANATOMIC PEEK PTC Cervical Fusion System -K160528
- Stryker Spine: AERO®-C Cervical Cage System – K152532
- Biomet Spine: C-Thru™ Anterior Spinal System - K151064
VII. INDICATIONS FOR USE
The Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the Calix-C™ Cervical Interbody Spacer.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., posterior cervical screw and rod systems and anterior cervical plate systems).
DEVICE DESCRIPTION VIII.
The Calix-C™ Cervical Interbody Spacer is an intervertebral fusion device, generally box or oval-shaped, that has various holes throughout its geometry. The device body is made from Invibio PEEK-Optima™ (polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560. Superior and inferior surfaces of the device have teeth to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without titanium plasma coating on the superior and inferior surfaces of the device. The plasma coating is made from medicalgrade titanium per ASTM F1580. The hollow center of the implant allows the device to
5
be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The system does not contain software/firmware.
IX. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The technological principle for both the subject and primary predicate device is fixation in the cervical spine for skeletally mature patients with degenerative disc disease.
As was established in this submission, the subject device, Calix-C™ Cervical Interbody Spacer, is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
X. PERFORMANCE DATA
Mechanical testing is recommended in the FDA special controls guidance document, "Class II Special Controls Guidance: Intervertebral Body Fusion Device". X-spine has previously submitted to the FDA results of performance testing for Calix cervical implants: K112036 and K083637, according to the following standards:
- ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices: ●
- Static and dynamic torsion testing o
- o Static and dynamic axial compression and compression shear testing
- ASTM F 2267-04 Test Methods for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- Expulsion testing as recommended by FDA
- . ASTM F 1580 -- Performance Qualification of Commercially Pure Titanium Plasma Spray (CP Ti)
Therefore, no new nonclinical testing was performed for the purpose of this submission.
XI. CONCLUSION
The subject device, Calix-C™ Cervical Interbody Spacer, has been modified to expand the Indications for Use and two additional footprints have been added. Based on the indications for use, technological characteristics, and comparison to predicate and reference devices, the subject Calix-C™ Cervical Interbody Spacer demonstrates substantial equivalence to legally marketed predicate devices.