(200 days)
No
The summary describes a passive, physical implant made of PEEK for spinal fusion, with no mention of software, algorithms, or data processing capabilities.
No
The device is described as an anterior cervical interbody fusion device, indicated for treating degenerative disc disease by assisting in interbody fusion, rather than directly providing therapy.
No
Explanation: This device is an anterior cervical interbody fusion device, a type of implant used for treatment (fusion), not for diagnosing conditions.
No
The device description explicitly states the device components are fabricated from PEEK and tantalum, which are physical materials, not software. The summary also describes mechanical testing (compression, torsion, subsidence) which is relevant to physical implants, not software.
Based on the provided information, the Chena Cervical Peek Spacer System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "anterior cervical interbody fusion device" used for surgical implantation in patients with degenerative disc disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the implant (spacers made of PEEK and tantalum) and their purpose in assisting interbody fusion. This aligns with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) from the human body to provide diagnostic information. The device is implanted directly into the patient.
Therefore, the Chena Cervical Peek Spacer System is a medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.
Product codes
ODP
Device Description
The Axis Chena Cervical PEEK Spacer System consists of a variety of footprints and heights of PEEK cervical interbody spacer implants to assist in interbody fusion.
The Axis Chena Cervical PEEK Spacer System implant components are fabricated from medical implant grade Polyetheretherketone and tantalum described by such standards as ASTM F2026-17 and ASTM F560-17. Axis Orthopaedics Corporation expressly warrants that these devices are fabricated from one of the foregoing material specifications.
Do not use any of the Axis Chena Cervical PEEK Spacer System implant components with components from any other system or manufacturer. As with all orthopaedic and neurosurgical implants, none of the Axis Chena Cervical PEEK Spacer System components should ever be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1 (cervical spine)
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 AXIS Orthopaedics Chena Cervical PEEK Spacer System was designed and tested as an interbody fusion device for the cervical spine. The objective of this testing was to demonstrate that the subject AXIS device is equivalent to predicate devices with respect to testing recommended in ASTM F2077-14 and F2267-11.
Static and dynamic compression and torsion testing and subsidence testing on the subject device was performed per the applicable standards referenced above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and white. The logo is commonly used to identify the FDA and its role in regulating food and drugs in the United States.
November 16, 2018
Axis Orthopaedics % Steve Brown OA/RA Manager CoorsTek Medical 560 W. Golf Course Rd. Providence, Utah 84332
Re: K181140
Trade/Device Name: Axis Chena Cervical PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: October 11, 2018 Received: October 15, 2018
Dear Mr. Brown:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
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INDICATIONS FOR USE
510(k) Number (if known): K181140
Device Name: Axis Chena Cervical PEEK Spacer System
Indications for Use:
The Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.
Prescription Use | X |
---|---|
(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
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K181140 - 510(k) SUMMARY
Device Trade Name: | Axis Chena Cervical PEEK Spacer System |
---|---|
Date: | April 23, 2018 |
Sponsor: | Axis Orthopaedics |
Contact Person: | Steve Brown |
Manufacturer: | Axis Orthopaedics |
Common Name: | Axis Chena Cervical PEEK Spacer System |
Device Classification: | Class II |
Classification Name: | Intervertebral Fusion Device with Bone Graft, Cervical |
Intervertebral body fusion device | |
Regulation: | 888.3080 |
Device Regulation Panel: | Orthopedic |
Device Product Code: | ODP |
Indications for Use:
The Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.
Device Description:
The Axis Chena Cervical PEEK Spacer System consists of a variety of footprints and heights of PEEK cervical interbody spacer implants to assist in interbody fusion.
The Axis Chena Cervical PEEK Spacer System implant components are fabricated from medical implant grade Polyetheretherketone and tantalum described by such standards as ASTM F2026-17 and ASTM F560-17. Axis Orthopaedics Corporation expressly warrants that these devices are fabricated from one of the foregoing material specifications.
Do not use any of the Axis Chena Cervical PEEK Spacer System implant components with components from any other system or manufacturer. As with all orthopaedic and neurosurgical implants, none of the Axis Chena Cervical PEEK Spacer System components should ever be reused under any circumstances.
4
Implant Materials
Material: | Standard: |
---|---|
Implant Grade PEEK | ASTM F2026-17 |
Tantalum | ASTM F560-17 |
Technological Characteristics:
There are no technological characteristics that raise new issues of safety or effectiveness.
Assessment of performance data:
The AXIS Orthopaedics Chena Cervical PEEK Spacer System was designed and tested as an interbody fusion device for the cervical spine. The objective of this testing was to demonstrate that the subject AXIS device is equivalent to predicate devices with respect to testing recommended in ASTM F2077-14 and F2267-11.
Static and dynamic compression and torsion testing and subsidence testing on the subject device was performed per the applicable standards referenced above.
Legally Marketed Predicate Devices:
Primary: DePuy Synthes ACIS - Anterior Cervical Interbody System (K120275) Reference: K2M Cascadia - Cervical Interbody (K162264)
Predicate Indications for Use:
Primary:
DePuy Synthes (K120275)- The Synthes ACIS System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The interior of the Synthes ACIS should be packed with autogenous bone graft material and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation.
Reference:
K2M (K162264)- The Cascadia cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Cascadia cervical implants are also to be used with supplemental fixation; the hyper lordotic Cascadia cervical implants (i.e.>= 10 °) are required to be used with an anterior cervical plate as the form of supplemental fixation.
Conclusion:
Based on the above information, it can be concluded that the subject device is substantially equivalent with respect to its intended use and technological characteristics.