K211111 · Additive Implants, Inc. · OVE · Jul 16, 2021 · Orthopedic
Device Facts
Record ID
K211111
Device Name
SureMAX-SA Cervical Standalone System
Applicant
Additive Implants, Inc.
Product Code
OVE · Orthopedic
Decision Date
Jul 16, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The SureMAX-SA™ Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients as an adjunct to fusion for the treatment of degenerative disc disease (DDD). DDD is defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with the device. The SureMAX-SA™ Cervical Standalone System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. When used with the fixed or variable screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one or two levels from C2-T1 and requires no additional fixation. When used with one or more helical screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one level and with supplemental fixation.
Device Story
SureMAX-SA Cervical Standalone System; additively manufactured interbody spacers with integrated fixation; used for anterior cervical interbody fusion. Device implanted via open, anterior approach by surgeons. Spacers feature open architecture; integrated fixation includes fixed, variable, or helical screw options. System provides structural support and stabilization for fusion; used with autograft or allogeneic bone graft. Benefits include restoration of disc height and stabilization of spinal segments in DDD patients. Clinical decision-making supported by radiographic confirmation of disc degeneration.
Clinical Evidence
Bench testing only. Mechanical testing of worst-case devices included subsidence, static/dynamic compression, static/dynamic compression shear, and static/dynamic torsion per ASTM F2267 and ASTM F2077. Screw pushout properties were also evaluated. Results demonstrate performance equivalence to predicate devices.
Technological Characteristics
Additively manufactured Ti-6Al-4V ELI titanium alloy (ASTM F3001 for spacers, ASTM F136 for screws/cams). Rounded rectangular spacer with open architecture. Integrated fixation via fixed, variable, or helical screws. Provided sterile.
Indications for Use
Indicated for skeletally mature patients with degenerative disc disease (DDD) presenting as discogenic neck pain, confirmed by history and radiography, who have failed six weeks of non-operative treatment. Used for interbody fusion at one or two levels (C2-T1) with fixed/variable screws (no supplemental fixation) or one level with helical screws (requires supplemental fixation).
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
COALITION MIS™ Spacer, Globus Medical, Inc. (K151939)
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July 16, 2021
Additive Implants, Inc % Karen Warden, PhD President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026
Re: K211111
Trade/Device Name: SureMAX-SATM Cervical Standalone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: June 11, 2021 Received: June 14, 2021
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.
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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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
for Brent 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
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: 06/30/2023 See PRA Statement below.
## 510(k) Number (if known)
## K211111
## Device Name
SureMAX-SA™ Cervical Standalone System
## Indications for Use (Describe)
The SureMAX-SA™ Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients as an adjunct to fusion for the treatment of degenerative disc disease (DDD). DDD is defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with the device. The SureMAX-SA™ Cervical Standalone System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. When used with the fixed or variable screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one or two levels from C2-T1 and requires no additional fixation. When used with one or more helical screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one level and with supplemental fixation.
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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# 510(k) Summary
| Date: | 9 June 2021 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Additive Implants, Inc.<br>3101 E. Shea Blvd, Suite 122<br>Phoenix, AZ 85028<br>Office: 602.795.8850<br>Fax: 602.595.7896 |
| Sponsor Contact: | Jeff Horn, Vice-President of Commercialization |
| 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting Inc.<br>PO Box 566<br>Chesterland, OH 44026<br>Office: 440.729.8457 |
| Proposed Trade Name: | SureMAX-SATM Cervical Standalone System |
| Common Name: | Interbody fusion system |
| Device Classification: | Class II |
| Regulation Name, Regulation Number, Product Code: | Intervertebral fusion device, 888.3080, OVE |
| Device Description: | The SureMAX-SATM Cervical Standalone System is a collection of additively<br>manufactured interbody spacers and integrated fixation for cervical<br>implantation The cervical spacers have basic rounded rectangular shape<br>and an open architecture. The integrated fixation consists of three screw<br>options. A variety of height, length, width and anteroposterior angulation<br>combinations are available to accommodate the anatomic requirements of<br>individual patients. The SureMAX-SATM Cervical Standalone System is<br>provided sterile. |
| Indications for Use: | The SureMAX-SATM Cervical Standalone System is a stand-alone anterior<br>cervical interbody fusion device indicated for use in skeletally mature<br>patients as an adjunct to fusion for the treatment of degenerative disc<br>disease (DDD). DDD is defined as discogenic neck pain with degeneration<br>of the disc confirmed by history and radiographic studies. These patients<br>should have had six weeks of non-operative treatment prior to treatment<br>with the device. The SureMAX-SATM Cervical Standalone System is to be<br>used with autograft bone graft and/or allogeneic bone graft composed of<br>cancellous and/or corticocancellous bone and implanted via an open,<br>anterior approach. When used with the fixed or variable screws, the<br>SureMAX-SATM Cervical Standalone System is intended to be used at one<br>or two levels from C2-T1 and requires no additional fixation. When used<br>with one or more helical screws, the SureMAX-SATM Cervical Standalone<br>System is intended to be used at one level and with supplemental fixation.. |
| Materials: | SureMAX-SATM Cervical Standalone System interbody implants are<br>manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001. The<br>fixation screws and locking cam subcomponents are manufactured from Ti-<br>6Al-4V ELI titanium alloy per F136. |
| Primary Predicate: | COALITION MISTM Spacer, Globus Medical, Inc. - K151939 |
| Additional Predicate: | Hexanium® ACIF, SpineVision SAS – K193000 |
| Performance Data: | Mechanical testing of worst case SureMAX-SA TM Cervical Standalone<br>System devices included subsidence, static and dynamic compression,<br>static and dynamic compression shear and static and dynamic torsion<br>according to ASTM F2267 and ASTM F2077. In addition, screw pushout<br>properties were evaluated.<br>The mechanical test results demonstrate that SureMAX-SATM Cervical<br>Standalone System performance is substantially equivalent to the predicate<br>devices. |
| Technological<br>Characteristics: | The SureMAX-SATM Cervical Standalone System possesses the same<br>technological characteristics as one or more of the predicate devices. These<br>include: intended use (as described above), basic design (additively<br>manufactured structure and integrated fixation), material (titanium alloy) and<br>sizes (dimensions are comparable to those offered by the predicate<br>systems).<br>Therefore the fundamental scientific technology of the SureMAX-SATM<br>Cervical Standalone System is the same as previously cleared devices. |
| Conclusion: | The SureMAX-SATM Cervical Standalone System possesses the same<br>intended use and technological characteristics as the predicate devices.<br>Therefore the SureMAX-SATM Cervical Standalone System is substantially<br>equivalent for its intended use. |
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
