(140 days)
Not Found
No
The summary describes a physical implant (cervical spacer) and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended for anterior intervertebral body fusion to treat cervical disc degeneration and/or cervical spinal instability, which are medical conditions, and aims to provide therapeutic benefit by relieving radiculopathy, myelopathy, and/or pain.
No
The device, a Cervical Spacer, is an implant used for anterior intervertebral body fusion to treat cervical disc degeneration and/or spinal instability. It is a therapy device, not a diagnostic one, as it does not diagnose or identify a medical condition.
No
The device description explicitly states it is an "additively manufactured interbody device" and describes its physical characteristics and mechanical testing, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Cervical Spacer Function: The Cervical Spacer is an implantable device designed to be surgically placed in the spine to facilitate fusion between vertebrae. It is a structural device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for "anterior intervertebral body fusion" to treat conditions like disc degeneration and instability. This is a therapeutic intervention, not a diagnostic one.
- Device Description: The description details its physical characteristics as an "additively manufactured interbody device" with a specific shape and materials. This aligns with a surgical implant, not a diagnostic kit or instrument.
- Lack of Diagnostic Components: There is no mention of reagents, assays, or any components typically associated with in vitro testing.
The information about imaging studies (radiographs, CT, MRI) is used to diagnose the patient's condition before the device is used, but the device itself is not performing the diagnostic function.
N/A
Intended Use / Indications for Use
The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer is to be used with supplemental fixation; the hyperlordotic implants (>=10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone shape and an open architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The Cervical Spacers are provided sterile only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
cervical disc, 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 of the worst case Cervical Spacer included static and dynamic compression and static torsion according to ASTM F2077. In addition, the subsidence properties were evaluated according to ASTM F2267 and expulsion according to the ASTM draft standard. The manufactured surface was evaluated according to ASTM F1978. The mechanical test results demonstrate that the Cervical Spacer performance is substantially equivalent to the predicate devices. In addition, bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit.
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.
K160125, K173324, K081730, K091088, P980048, K024364
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.
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August 4, 2021
Additive Implants, LLC % Karen Warden, Ph.D. President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026
Re: K182477
Trade/Device Name: Cervical Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP
Dear Dr. Warden:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on January 28, 2019. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.
Sincerely,
Brent Showalter -S
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services. On the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. Food & Drug Administration".
Additive Implants, LLC % Karen Warden President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026
Re: K182477
Trade/Device Name: Cervical Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 27, 2018 Received: December 27, 2018
Dear Karen Warden:
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. Although this letter refers to your product as a device, please be aware 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
2
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.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
David Hwang -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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Cervical Spacer
Indications for Use (Describe)
The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/ or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone to facilitate fusion.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date: | 27 December 2018 |
|---|---|
| Sponsor: | Additive Implants, LLC |
| 3101 E. Shea Blvd, Suite 114 | |
| Phoenix, AZ 85028 | |
| Office: 602.795.8850 | |
| Fax: 602.595.7896 | |
| Sponsor Contact: | Jeff Horn, Vice-President of Commercialization |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | Cervical Spacer |
| Common Name: | Cervical interbody fusion device |
| Device Classification: | Class II |
| Regulation Names, | |
| Regulation Numbers, | |
| Product Codes: | Intervertebral fusion device with bone graft, 888.3080, cervical, ODP |
| Device Description: | The Cervical Spacer is an additively manufactured interbody device. These |
| cervical implants have basic keystone shape and an open architecture. A | |
| variety of height, length, width and anteroposterior angulation combinations | |
| are available to accommodate the anatomic requirements of individual | |
| patients. The Cervical Spacers are provided sterile only. | |
| Indications for Use: | The Cervical Spacer is intended for anterior intervertebral body fusion in |
| skeletally mature patients who have had at least six weeks of non-operative | |
| treatment. The Cervical Spacer is indicated to treat cervical disc | |
| degeneration and/or cervical spinal instability, as confirmed by imaging | |
| studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, | |
| and/or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer | |
| is to be used with supplemental fixation; the hyperlordotic implants (≥10°) | |
| are required to be used with an anterior cervical plate. The implants are | |
| designed for use with autogenous and/or allogeneic bone graft comprised of | |
| cancellous and/or corticocancellous bone to facilitate fusion. | |
| Materials: | The Cervical Spacer implants are manufactured from Ti-6Al-4V ELI titanium |
| alloy (ASTM F3001, Grade 23). | |
| Primary Predicate: | Cascadia Interbody System (K2M Inc. - K160125) |
| Additional Predicates: | ALTA Anterior Cervical Interbody Spacer (Astura Medical - K173324), |
| Novel System (Alphatec Spine Inc. - K081730), MC+ (LDR Holding - | |
| K091088), BAK/C Interbody Fusion System (Centerpulse - SpineTech, Inc. |
- P980048), SynCage-C (Synthes Spine – K024364) |
| Performance Data: | Mechanical testing of the worst case Cervical Spacer included static and
dynamic compression and static torsion according to ASTM F2077. In
addition, the subsidence properties were evaluated according to ASTM
F2267 and expulsion according to the ASTM draft standard. The
manufactured surface was evaluated according to ASTM F1978.
The mechanical test results demonstrate that the Cervical Spacer
performance is substantially equivalent to the predicate devices.
In addition, bacterial endotoxin testing was conducted in accordance with
AAMI ST72:2011 and met the specified testing limit. |
| Technological
Characteristics: | The Cervical Spacer possesses the same technological characteristics as
one or more of the predicate devices. These include:
• intended use (as described above)
• basic design (additively manufactured structure),
• material (titanium alloy) and
• sizes (dimensions are comparable to those offered by the predicate
systems)
The Cervical Spacer is the same as previously cleared devices. |
| Conclusion: | The Cervical Spacer possesses the same intended use and technological
characteristics as the predicate devices. Therefore the Cervical Spacer is
substantially equivalent for its intended use. |
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