(30 days)
Not Found
No
The summary describes a physical medical device (cervical spacers) and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat cervical disc degeneration and/or cervical spinal instability, and facilitate fusion, indicating a therapeutic purpose.
No
Explanation: The SureMAX™ Family of Cervical Spacers is described as an interbody system intended for anterior intervertebral body fusion. This is an implantable device used in treatment, not for diagnosing conditions. While its indication relies on prior imaging studies for diagnosis, the device itself is therapeutic.
No
The device description clearly states it is an "additively manufactured interbody system" and describes physical implants (spacers) with specific shapes and dimensions, indicating it is a hardware device.
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.
- Device Function: The SureMAX™ Family of Cervical Spacers is an implantable device designed to be surgically placed in the spine to facilitate bone fusion. It is a structural device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for "anterior intervertebral body fusion" and to "treat cervical disc degeneration and/or cervical spinal instability." This is a therapeutic intervention, not a diagnostic one.
- Device Description: The description details the physical characteristics of the implant (shape, material, sizes), not a testing methodology.
- Performance Studies: The performance studies focus on mechanical properties (compression, torsion, subsidence, expulsion), which are relevant to the structural integrity of an implant, not the accuracy of a diagnostic test.
The information about imaging modalities (radiographs, CT, MRI) is mentioned because these are used to diagnose the patient's condition and plan the surgical procedure, but the device itself is not performing the diagnostic function.
N/A
Intended Use / Indications for Use
The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers 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 SureMAX™ Family of Cervical Spacers 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 SureMAX™ Family of Cervical Spacers is an additively manufactured interbody system. 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 SureMAX™ Family of Cervical Spacers is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified SureMAX™-X cervical spacer was evaluated via mechanical testing per ASTM F2077 (including static and dynamic compression and static and dynamic torsion), ASTM F2267 (subsidence) and expulsion. The results demonstrated the performance of the modified cervical spacer is substantially equivalent to the predicate.
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.
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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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
January 3, 2020
Additive Implants, Inc. % Karen E. Warden, PhD President BackRoads Consulting, Inc. 12520 Heath Road Chesterland, Ohio 44026
Re: K193359
Trade/Device Name: SureMAXTM Family of Cervical Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 3, 2019 Received: December 4, 2019
Dear Dr. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K193359
Device Name SureMAX™ Family of Cervical Spacers
Indications for Use (Describe)
The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MR), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers 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.
| 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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510(k) Summary
| Date: | 3 December 2019 |
|---|---|
| Sponsor: | Additive Implants, Inc. |
| 3101 E. Shea Blvd, Suite 122 | |
| 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: | SureMAX™ Family of Cervical Spacers |
| Common Name: | Interbody fusion system |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Code: | Intervertebral fusion device with bone graft, cervical, 888.3080, ODP |
| Submission Purpose: | The subject 510(k) adds a new anterior cervical spacer (SureMAX™-X) to |
| the SureMAX™ Family of Cervical Spacers. | |
| Device Description: | The SureMAX™ Family of Cervical Spacers is an additively manufactured |
| interbody system. 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 SureMAX™ Family of Cervical | |
| Spacers is provided sterile. | |
| Indications for Use: | The SureMAX™ Family of Cervical Spacers is intended for anterior |
| intervertebral body fusion in skeletally mature patients who have had at | |
| least six weeks of non-operative treatment. The SureMAX™ Family of | |
| Cervical Spacers 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 SureMAX™ Family of Cervical Spacers | |
| 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 SureMAX™ Family of Cervical Spacers is manufactured from Ti-6Al-4V |
| ELI titanium alloy (ASTM F3001, Grade 23). | |
| Primary Predicate: | Cervical Spacer (Additive Implants, LLC - K182477) |
| Additional Predicates: | Cascadia Interbody System (K2M Inc. – K160125), Aleutian IBF System |
| (K2M Inc. - K082698) | |
| Performance Data: | The modified SureMAX™-X cervical spacer was evaluated via mechanical |
| testing per ASTM F2077 (including static and dynamic compression and | |
| static and dynamic torsion), ASTM F2267 (subsidence) and expulsion. The | |
| results demonstrated the performance of the modified cervical spacer is | |
| substantially equivalent to the predicate. |
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| Technological
Characteristics: | The modified SureMAX™-X cervical spacer possesses the same
technological characteristics as one or more of the predicate devices. These
include:
• performance (as described above),
• basic design (additively manufactured structural interbody),
• material (titanium alloy) and
• size (dimensions are comparable to those offered by the cleared
devices).
Therefore the fundamental scientific technology of the modified
SureMAX™-X cervical spacer is the same as previously cleared devices. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The modified SureMAX™-X cervical spacer possesses the same intended
use and technological characteristics as the predicate devices. Therefore
the modified SureMAX™-X cervical spacer is substantially equivalent for its
intended use. |