K153782 · Nu Vasive, Incorporated · MAX · Mar 24, 2016 · Orthopedic
Device Facts
Record ID
K153782
Device Name
NuVasive® Lumbar Interbody Implants
Applicant
Nu Vasive, Incorporated
Product Code
MAX · Orthopedic
Decision Date
Mar 24, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
NuVasive® Lumbar Non-Interfixated Interbody Implants: The NuVasive Lumbar Non-Interbody Implants, including CoRoent System and CoRoent Ti-C System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The Lumbar Non-Interfixated Interbody Implants (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. NuVasive® Lumbar Interfixated Interbody Implants: The NuVasive Lumbar Interfixated Interbody Implants, including CoRoent Single Tab System, CoRoent XL-F System, Brigade Standalone System, and Brigade Hyperlordotic System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The Lumbar Interfixated Interbody Implants are intended for two contiguous level or two contiguous levels in the lumbar spine (L2-S1 for Brigade Systems and L2-L5 for CoRoent Single Tab and XL-F) for the treatment of desc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. CoRoent Single Tab System, CoRoent XL-F System, and Brigade Hyperlordotic System are intended to be used with supplemental fixation systems that that are cleared by the FDA for use in the lumbosacral spine.
Device Story
Lumbar interbody implants; PEEK-Optima LT-1 or PEEK with titanium coating; hollow core for bone graft packing; surface spikes/teeth for migration resistance. Interfixated versions include integrated screw holes/tabs for titanium alloy screws. Used in lumbar spine (L2-S1) for fusion; requires supplemental fixation. Implanted by surgeons during spinal fusion procedures to treat degenerative disc disease. Benefits include stabilization of vertebral segments and promotion of bony fusion.
Clinical Evidence
No clinical studies conducted. Evidence consists of a clinical literature review supporting the use of the device with allogeneic bone graft for lumbar interbody fusions, demonstrating a safety and effectiveness profile similar to predicate devices.
Technological Characteristics
Materials: PEEK-Optima LT-1 (ASTM F2026), CP Ti coating, MP35N (ASTM F562), titanium alloy (ASTM F136, ISO 5832-3), tantalum (ISO 13782). Features: Hollow core for graft, integrated screw fixation (interfixated models), radiographic markers. No software or electrical components.
Indications for Use
Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous levels (L2-S1). Requires at least six months of failed non-operative treatment. Used with autogenous and/or allogeneic bone graft and supplemental internal spinal 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
Stryker Spine AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS Anchor-L Spacer, and Aero-AL Lumbar Cage System (K143163)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
NuVasive, Incorporated Martin Yahiro, M.D. Director, Medical Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K153782
Trade/Device Name: NuVasive® Lumbar Interbody Implants Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD Dated: December 30, 2015 Received: December 31, 2015
Dear Dr. Yahiro:
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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Mark N. Melkerson -S
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)
### K153782
Device Name NuVasive® Lumbar Interbody Implants
### Indications for Use (Describe)
NuVasive® Lumbar Non-Interfixated Interbody Implants:
The NuVasive Lumbar Non-Interbody Implants, including CoRoent System and CoRoent Ti-C System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Lumbar Non-Interfixated Interbody Implants (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
NuVasive® Lumbar Interfixated Interbody Implants:
The NuVasive Lumbar Interfixated Interbody Implants, including CoRoent Single Tab System, CoRoent XL-F System, Brigade Standalone System, and Brigade Hyperlordotic System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Lumbar Interfixated Interbody Implants are intended for two contiguous level or two contiguous levels in the lumbar spine (L2-S1 for Brigade Systems and L2-L5 for CoRoent Single Tab and XL-F) for the treatment of desc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
CoRoent Single Tab System, CoRoent XL-F System, and Brigade Hyperlordotic System are intended to be used with supplemental fixation systems that that are cleared by the FDA for use in the lumbosacral spine.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font.
## 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:
Martin Yahiro, M.D. Director, Medical Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 638-5589
Date Prepared: December 30, 2015
#### B. Device Name
| Trade or Proprietary Name: | NuVasive® Lumbar Interbody Implants |
|----------------------------|----------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Spinal Intervertebral Body Fixation orthosis |
| Device Class: | Class II |
|-----------------|-------------------|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | MAX, OVD |
#### C. Predicate Devices
The subject NuVasive Lumbar Interbody Implants is substantially equivalent to the primary predicate device the Stryker Spine AVS® AL and AVS® ALign PEEK Spacers, AVS® PL and AVS® UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, and Aero"-AL Lumbar Cage System (K143163) and additional predicate devices, CoRoent System (K141665); CoRoent Ti-C System (K140319); CoRoent Single Tab System (K131723); CoRoent XL-F System (K140479); CoRoent XLR Standalone System (K100043); and Brigade Hyperlordotic System (K123045).
#### Device Description D.
The subject NuVasive Lumbar Interbody Implants are interbody implants manufactured from PEEK-Optima LT-1 conforming to ASTM F2026. Additinally, CoRoent Ti-C implants are PEEK devices with a commercially pure titanium (CP Ti) coating applied to the superior and inferior surfaces of the device. The PEEK devices contain titanium alloy radiographic markers conforming to ASTM F136 or ASTM F1472 or tantalum markers conforming to ASTM 560 or ISO 13782. The device's hollow core or graft aperture allows for packing of graft material to help promote a solid fusion. Small spikes or teeth on each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device.
The interfixated version of the subject NuVasive Lumbar Interbody Implants devices are composed of an interbody device manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM
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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. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font size.
F136 and ISO 5832-3. The Lumbar Interfixated Interbody System implants have four screw holes in the anterior wall of the PEEK implant that allow titanium alloy screws to be placed in the cranial and caudal vertebral bodies or one or two integrated tabs to allow a titanium alloy screw to be placed in the cranial and caudal vertebral bodies. Additionally, implants include titanium alloy radiographic markers conforming to industry recognized standards.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. In addition to the integrated screws, the device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
#### E. Indications for Use
# NuVasive® Lumbar Non-Interfixated Interbody Implants:
The NuVasive Lumbar Non-Interfixated Interbody Implants, including CoRoent System and CoRoent Ti-C System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of nonoperative treatment.
The Lumbar Non-Interfixated Interbody Implants (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
# NuVasive® Lumbar Interfixated Interbody Implants:
The NuVasive Lumbar Interfixated Interbody Implants, including CoRoent Single Tab System, CoRoent XL-F System, Brigade Standalone System, and Brigade Hyperlordotic System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Lumbar Interfixated Interbody Implants are intended for use at either one level or two contiguous levels in the lumbar spine (L2-S1 for Brigade Systems and L2-L5 for CoRoent Single Tab and XL-F) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
CoRoent Single Tab System, CoRoent XL-F System, and Brigade Hyperlordotic System are intended to be used with supplemental fixation systems that that are cleared by the FDA for use in the lumbosacral spine.
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Image /page/6/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font.
#### F. Technological Characteristics
As was established in this submission, the subject NuVasive Lumbar Interbody Implants is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was 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.
#### G. Performance Data
Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use in the lumbosacral spine when used with autogenous bone graft: worst case devices included with the subject system were tested and cleared in these predicate 510(k) submissions. The proposed expansion of the indications for use to include the use of allograft does not create a new mechanical worst-case for any of the implants. Since no new device designs and no new worst case sizes are being introduced to the subject NuVasive Lumbar Interbody Implants, the previously presented mechanical testing data are sufficient to support the proposed use of allograft with the subject system and does not warrant the need for additional nonclinical testing. Therefore, no new mechanical testing was performed for this 510(k) submission.
A clinical literature review was performed to support the use of the subject device with allogeneic bone graft for interbody fusions of the lumbar spine. Based on the published clinical literature review, it was determined that the NuVasive Lumbar Interbody Implants used in the treatment of lumbar degenerative disc disease has a safety and effectiveness profile that is similar to the predicate devices.
The subject NuVasive Lumbar Interbody Implants meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.
#### H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject NuVasive Lumbar Interbody Implants has been shown to be substantially equivalent to legally marketed predicate devices.
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.
