(259 days)
No
The device description explicitly states "The system does not contain software/firmware." and there are no mentions of AI, DNN, or ML.
Yes
The device is described as an "intervertebral fusion device" intended for spinal fusion procedures in patients with degenerative disc disease, which clearly indicates its purpose is to treat a medical condition.
No
Explanation: The Calix® Lumbar Spinal Implant System is an intervertebral fusion device intended for spinal fusion procedures. It is a surgical implant designed to provide structural support and facilitate bone fusion, not to diagnose a condition.
No
The device description explicitly states, "The system does not contain software/firmware."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical implant designed to be placed between vertebrae. It is made of materials like PEEK and titanium and is intended to facilitate bone fusion.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described are mechanical tests evaluating the physical properties and performance of the implant itself, not diagnostic accuracy or analytical performance.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The X-spine Calix® Lumbar Spinal Implant System is an intervertebral fusion device for use with bone graft, designed for surgical placement between adjacent vertebrae of the lumbar spine as an adjunct to fusion.
The X-spine Calix® Lumbar Spinal Implant System is a generally hollow box or oval shaped device manufactured from Invibio PEEK-Optima™ LT1 per ASTM F2026. The device contains an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without a medical grade commercially pure titanium (CP Ti) plasma coating (per ASTM F1580) on the superior and inferior surfaces of the device.
The hollow center of the implant allows the device to be packed with bone graft: autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft,
The single use implants are supplied in several width, height and lordosis options to accommodate variations in patient anatomy and differing pathologies. The devices contain radiographic markers made from tantalum per ASTM F560 to aid in final placement verification. Plasma coated implants are provided clean and sterile. Nonplasma coated implants and instruments are provided non-sterile. All implants are intended for single use only, and should not be reused under any circumstances.
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
Lumbosacral spine (L2 - S1 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)
The predicate system, Calix® Lumbar Spinal Implant System (K131350), was subjected to the following mechanical testing as recommended in the special controls guidance document, "Class II Special Controls Guidance: Intervertebral Body Fusion Device".
Therefore most of those tests were not repeated, since the size offerings and footprints of the coated implants are the same as the uncoated:
- ASTM F2077- Test Methods for Intervertebral Body Fusion Devices
- . Expulsion testing as recommended by FDA
- ASTM F2267-04 Test Methods for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
For the proposed Calix® Lumbar Spinal Implant System (with titanium plasma coated implants) testing was performed in order to demonstrate that the new titanium plasma coated implants perform as well as or better than the predicate device, Calix® Lumbar Spinal Implant System (K131350). The tests that were performed are:
- . ASTM F2077 Test Methods for Intervertebral Body Fusion Devices: Dynamic Compression Shear
- Expulsion Testing as recommended by the FDA
- ASTM F1877 Standard Practice for Characterization of Particles.
The results of the testing demonstrate that the addition of the medical grade commercially pure titanium plasma coating does not present a new worst case, and does not impact the performance of the implants.
The proposed expansion of the indications for use, i.e. the addition of the use of allograft, does not impact the mechanical performance of the Calix® Lumbar Titanium Plasma Coated implants, and does not introduce new risks. Allograft has been 510k cleared for a large number of spinal implants that formerly were cleared only for autograft.
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.
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.
K161230, K160958, K160597, K153782, K112036
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
Image /page/0/Picture/4 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in a flowing, abstract manner.
X-spine Systems, Inc. Charlene Brumbaugh Regulatory Affairs Manager 452 Alexandersville Rd. Miamisburg, Ohio 45342
Re: K170119
Trade/Device Name: Calix® Lumbar Spinal Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 29, 2017 Received: August 30, 2017
Dear Ms. Brumbaugh:
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 (DICE) 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 (DICE) 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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K170119
Device Name
Calix® Lumbar Spinal Implant System
Indications for Use (Describe)
The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(K) SUMMARY (21 CFR 807.92)
Calix® Lumbar Spinal Implant System
Date Prepared: August 29, 2017
| 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: | Charlene Brumbaugh
Regulatory Affairs Manager
Email: cbrumbaugh@X-spine.com
Telephone (937) 847-8400, ext. 2192 |
| II. 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 |
| III. DEVICE | |
| Trade/Proprietary Name: | Calix® Lumbar Spinal Implant System |
| Device Common Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 21 CFR §888.3080 |
| Product Code: | MAX -- Intervertebral body fusion device |
Regulatory Class: Review Panel:
with Bone Graft, Lumbar Class II with Special Controls Orthopedic
4
IV. PREDICATE DEVICES
- Primary: X-spine, Inc.: Calix® Lumbar Spinal Implant System (K131350) ●
- Additional: ●
REFERENCE DEVICES V.
- NuVasive Lumbar Interbody Implants (K161230)
- Alphatec Spine: Battalion Universal Spacer System (K160958) ●
- Globus Medical: Independence MIS Spacers (K160597) ●
- NuVasive® Lumbar Interbody Implants (K153782)
Additional Reference Device:
X-spine Calix™ Cervical PC Spinal Implant System (K112036) is included because it is an intervertebral body fusion device that is CP-Ti plasma coated PEEK, provided non-sterile, and manufactured using the same materials and same processes as the proposed devices in this submission.
INDICATIONS FOR USE VI.
The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
VII. DEVICE DESCRIPTION
The X-spine Calix® Lumbar Spinal Implant System is an intervertebral fusion device for use with bone graft, designed for surgical placement between adjacent vertebrae of the lumbar spine as an adjunct to fusion
5
The X-spine Calix® Lumbar Spinal Implant System is a generally hollow box or oval shaped device manufactured from Invibio PEEK-Optima™ LT1 per ASTM F2026. The device contains an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without a medical grade commercially pure titanium (CP Ti) plasma coating (per ASTM F1580) on the superior and inferior surfaces of the device.
The hollow center of the implant allows the device to be packed with bone graft: autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft,
The single use implants are supplied in several width, height and lordosis options to accommodate variations in patient anatomy and differing pathologies. The devices contain radiographic markers made from tantalum per ASTM F560 to aid in final placement verification. Plasma coated implants are provided clean and sterile. Nonplasma coated implants and instruments are provided non-sterile. All implants are intended for single use only, and should not be reused under any circumstances.
The system does not contain software/firmware.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES VIII.
The technological principle for both the subject and primary predicate device is fixation at one or two contiguous levels (L2—S1 inclusive) in the lumbosacral spine for skeletally mature patients with degenerative disc disease.
Primary Predicate Device:
The subject device, Calix® Lumbar Spinal Implant System and the primary predicate device, Calix® Lumbar Spinal Implant System (K131350) are based on the following technological elements:
- o Same FDA Product Code: MAX -- Intervertebral Body Fusion Device, Lumbar with Bone Graft.
- Same implant materials: Invibio PEEK-Optima™ LT1 with tantalum markers. o
- Equivalent Indications for Use. O
- Multiple lengths, widths, and heights to account for variations in patient O anatomy. Same range of sizes of devices offered.
- Same anatomical region: one or two contiguous levels (L2-S1 inclusive). O
- Same surgical approaches: Anterior, posterior, and/or transforaminal. O
- Mechanical performance. O
The subject device has two additional technological elements:
- Expansion of the Indications for Use to include the use of allograft comprised O of cancellous and/or corticocancellous bone graft.
- Addition of medical-grade titanium plasma coating (CP Ti) per ASTM F1580 o on the superior and inferior surfaces of the implants.
6
Additional Predicate Devices:
- . NuVasive CoRoent Ti-C System (K160916) has the same technological elements that are listed above for the subject device and the primary predicate device. It also has the two additional technological elements that are listed referenced above, allograft and titanium plasma coating.
- Biomet Zyston Straight Interbody Spacer System (K112014) has similar technological elements to the Calix® Lumbar Spinal Implant System. It is included in this 510k for comparison of performance data.
Reference Devices:
- NuVasive Lumbar Interbody Implants (K161230)
- Alphatec Spine: Battalion Universal Spacer System (K160958)
- Globus Medical: Independence MIS Spacers (K160597)
- . NuVasive® Lumbar Interbody Implants (K153782)
The above reference devices have been 510k cleared with the same or similar technological elements as included in the Calix subject device:
- Indications for Use including allograft along with autograft
- . Anatomical region of one or two contiguous levels (L2—S1 inclusive)
- MAX product code
- Implant materials of PEEK and/or Titanium Alloy
- . Coated with medical grade commercially pure titanium (CP Ti) plasma coating
Additional Reference Device:
- . X-spine Calix™ Cervical PC Spinal Implant System (K112036) is included because it is an intervertebral body fusion device that is CP-Ti plasma coated PEEK, and manufactured using the same materials and same processes as the proposed devices in this submission.
IX. PERFORMANCE DATA
The predicate system, Calix® Lumbar Spinal Implant System (K131350), was subjected to the following mechanical testing as recommended in the special controls guidance document, "Class II Special Controls Guidance: Intervertebral Body Fusion Device".
7
Therefore most of those tests were not repeated, since the size offerings and footprints of the coated implants are the same as the uncoated:
- ASTM F2077- Test Methods for Intervertebral Body Fusion Devices
- . Expulsion testing as recommended by FDA
- ASTM F2267-04 Test Methods for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
For the proposed Calix® Lumbar Spinal Implant System (with titanium plasma coated implants) testing was performed in order to demonstrate that the new titanium plasma coated implants perform as well as or better than the predicate device, Calix® Lumbar Spinal Implant System (K131350). The tests that were performed are:
- . ASTM F2077 Test Methods for Intervertebral Body Fusion Devices: Dynamic Compression Shear
- Expulsion Testing as recommended by the FDA
- ASTM F1877 Standard Practice for Characterization of Particles.
The results of the testing demonstrate that the addition of the medical grade commercially pure titanium plasma coating does not present a new worst case, and does not impact the performance of the implants.
The proposed expansion of the indications for use, i.e. the addition of the use of allograft, does not impact the mechanical performance of the Calix® Lumbar Titanium Plasma Coated implants, and does not introduce new risks. Allograft has been 510k cleared for a large number of spinal implants that formerly were cleared only for autograft.
X. CONCLUSION
The subject device, Calix® Lumbar Spinal Implant System, has been modified to expand the Indications for Use, and to add medical grade commercially pure titanium (CP Ti) plasma coated versions of the original Calix® Lumbar implants. Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Calix® Lumbar Spinal Implant System demonstrates substantial equivalence to legally marketed predicate devices.