NuVasive Cohere ALIF System Intervertebral Body Fusion Device
K221751 · Nu Vasive, Incorporated · OVD · Oct 21, 2022 · Orthopedic
Device Facts
Record ID
K221751
Device Name
NuVasive Cohere ALIF System Intervertebral Body Fusion Device
Applicant
Nu Vasive, Incorporated
Product Code
OVD · Orthopedic
Decision Date
Oct 21, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The NuVasive Cohere ALIF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Cohere ALIF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cohere ALIF System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervertebral Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
Device Story
The Cohere ALIF System is a sterile, single-use intervertebral body fusion device composed of polyetheretherketone (PEEK). The device features a porous architecture on select surfaces to facilitate fusion and includes radiolucent markers for X-ray visualization. It is available in various footprints, heights, and lordotic angles. The device is implanted by a surgeon during spinal fusion procedures. Depending on the lordotic angle (10°-20° vs 25°-30°) and the patient's specific pathology (e.g., multilevel deformity), the device is used either as a standalone system or in conjunction with supplemental internal spinal fixation (e.g., posterior pedicle screw and rod systems). The device is packed with autogenous or allogeneic bone graft or bone void filler to promote fusion. By stabilizing the intervertebral space, the device aims to alleviate symptoms associated with degenerative conditions and restore spinal alignment.
Clinical Evidence
No clinical studies were conducted. Substantial equivalence was demonstrated through non-clinical bench testing, including static and dynamic compression, compression shear, subsidence, and screw push-out analysis.
Technological Characteristics
Material: Polyetheretherketone (PEEK) with radiolucent markers. Design: Interbody cage with porous architecture. Standards: ASTM F2077 (compression/shear), ASTM F1714 and F1877 (gravimetric/particulate). No software or electrical components.
Indications for Use
Indicated for skeletally mature patients requiring spinal fusion in the lumbar spine (L2-S1) for symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, or multilevel degenerative scoliosis and sagittal deformity. Patients must have failed at least six months of non-operative treatment.
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
NuVasive Thoracolumbar Interbody Systems (K23704)
NuVasive Thoracolumbar Interbody Systems (K203201)
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October 21, 2022
NuVasive, Incorporated Jessica LeBlanc Manager Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K221751
Trade/Device Name: NuVasive® Cohere® ALIF System Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: September 26, 2022 Received: September 29, 2022
Dear Ms. LeBlanc:
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
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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.
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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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## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
## 510(k) Number (if known) K221751
### Device Name
Nu Vasive Cohere ALIF System Intervertebral Body Fusion Device
## Indications for Use (Describe)
The Nu Vasive Cohere ALF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Interverebird Body Fusion Device 10-200 lordotic cages may be used as a standalone system. The System Intervetebral Body Fusion Device 25-30° lordotic cages may be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneis bone graft, intervertebral hody fraise to corticocancellous bone graft, or a bone void filler as cleared by FDA, for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had alleast sim onths of non-operative treatment.
The NuVasive Cohere ALLF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectory in the trestment of symptomatic degenerative disc disease (DD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disconfirmed by history and radiographic studies. The Cohere ALFE System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative spondylolisthanis as saind the used in these patients at multiple levels at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervetebrah Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the internal spillal fixal.
| Type of Use (Select one or both, as applicable) | <span> <b> <span style="text-decoration: overline;">X</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is divided into two parts, with the top part in purple and the bottom part in gray. The word "NUVASIVE" is in a sans-serif font.
Traditional 510(k) Premarket Notification NuVasive® Cohere® ALIF System Intervertebral Body Fusion Device
## 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
#### A. Submitted by:
Jessica LeBlanc Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (951) 816-0973
Date Prepared: June 3, 2022
#### B. Device Name
| Trade or Proprietary Name: | NuVasive® Cohere® ALIF System<br>Intervertebral Body Fusion Device |
|----------------------------|--------------------------------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
| Classification: | 21 CFR 888.3080 |
| Product Code: | OVD |
#### C. Predicate Devices
The subject NuVasive Cohere ALIF System Intervertebral Body Fusion Device is substantially equivalent to the primary predicate device NuVasive Thoracolumbar Interbody Systems (K23704) and the additional predicate devices, NuVasive Thoracolumbar Interbody Systems (K203201), and NuVasive Foundation-LL System (K152943).
#### D. Device Description
The Cohere ALIF System Intervertebral Body Fusion Device is inclusive of sterile, single use interbody implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights. Each device within the Cohere ALIF System Intervertebral Body Fusion Devce is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly contains radiolucent markets to enable visibility under x-ray in vivo. The implants are available in a variety of sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
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Image /page/4/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray.
#### E. Indications for Use
The NuVasive Cohere ALIF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The NuVasive Cohere ALIF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cohere ALIF System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervertebral Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
#### F. Technological Characteristics
As was established in this submission, the subject Cohere ALIF System Intervertebral Body Fusion Device is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject devices were shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
#### Performance Data G.
Non-clinical testing was performed to demonstrate that the subject Cohere ALIF System Intervertebral Body Fusion Device is substantially equivalent to other predicate devices. The following testing was performed:
- · Static and Dynamic Compression (per ASTM F2077)
- · Static and Dynamic Compression Shear (per ASTM F2077)
- . Gravimetric and Particulate Analysis (ASTM F1714 and F1877)
- Subsidence and screw push-out analysis .
The results demonstrate that the subject Cohere ALIF System Intervertebral Body Fusion Device meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicates. No clinical studies were conducted.
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Image /page/5/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray.
#### H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Cohere ALIF System Intervertebral Body Fusion Device has been shown to be substantially equivalent to legally marketed predicate devices.
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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.
