Monterey™ AL Interbody System - Stand-Alone The Stryker Spine Monterey™ AL Interbody System - Stand-Alone (AL Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis. The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach. The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation). Monterey™ AL Interbody System - Spacer The Stryker Spine Monterey™ AL Interbody System - Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis. The Monterey™ AL Spacer System is intended to be implanted via an anterior approach. The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.
Device Story
Anterior lumbar interbody fusion (IBD) system; utilizes Laser Rapid Manufacturing (LRM) to create porous and solid structures via Tritanium® In-Growth Technology. Implanted via anterior approach by surgeons. Two configurations: stand-alone (includes integrated bone screws) or spacer (requires supplemental fixation). Wedge-shaped design with central graft space and lateral windows for visualization. Provides structural support and promotes fusion in lumbosacral spine. Benefits include biological fixation and maximized endplate contact area.
Clinical Evidence
Bench testing only. No clinical data provided. Mechanical testing performed per FDA guidance for intervertebral body fusion devices, including static/dynamic compression, compression-shear, torsion, expulsion, subsidence, wear particulate analysis, impaction, and screw performance (push-out/pull-through).
Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade I spondylolisthesis or retrolisthesis, and patients with degenerative scoliosis, following six months of failed non-operative therapy.
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.
Synthes SYNFIX Evolution Secured Spacer System (K150673)
4WEB Anterior Spine Truss System – Stand Alone (ASTS-SA) (K200002)
Stryker Tritanium® C Anterior Cervical Cage (K171496)
Submission Summary (Full Text)
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August 10, 2020
Stryker Corporation Ms. Alexia Haralambous Senior Staff Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K201585
Trade/Device Name: Monterey™ AL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: June 10, 2020 Received: June 11, 2020
Dear Ms. Haralambous:
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.
Brent Showalter, Ph.D. Acting 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
510(k) Number (if known) K201585
Device Name Monterey™ AL Interbody System
## Indications for Use (Describe)
#### Monterey™ AL Interbody System - Stand-Alone
The Stryker Spine Monterey™ AL Interbody System - Stand-Alone (AL Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.
The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation).
Monterey™ AL Interbody System - Spacer
The Stryker Spine Monterey™ AL Interbody System - Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Spacer System is intended to be implanted via an anterior approach.
The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.
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: Monterey™ AL Interbody System | |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Submitter: | Stryker Spine<br>2 Pearl Ct.<br>Allendale, NJ 07401 |
| Contact Person: | Name: Alexia Haralambous<br>Phone: (201) 749-8518<br>Email: alexia.haralambous@stryker.com |
| Date Prepared: | August 7, 2020 |
| Trade Name: | Monterey™ AL Interbody System |
| Common Name: | Intervertebral body fusion device |
| Proposed Class: | Class II |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar (21 CFR<br>888.3080)<br>Intervertebral Body Fusion Device with Bone Graft, Lumbar (21 CFR<br>888.3080) |
| Product Code: | OVD, MAX |
| Predicate Devices: | Primary Predicate:<br>• K2M SAHARA Stabilization System (K151481)<br>Additional Predicates:<br>• Stryker AVS Anchor-L Lumbar Cage System (K143163, K120869)<br>• Centinel Spine STALIF TT (K073109)<br>• Stryker Tritanium® PL Posterior Lumbar Cage (K181014, K160955, K152304)<br>• Stryker Tritanium® TL Posterior Curved Lumbar Cage (K173476)<br>• Stryker Tritanium® X PL Expandable Posterior Lumbar Cage;<br>Tritanium® X TL Expandable Curved Posterior Lumbar Cage (K200613, K183249)<br>• Globus Independence® Spacers (K170157)<br>• Synthes SYNFIX Evolution Secured Spacer System (K150673)<br>• 4WEB Anterior Spine Truss System – Stand Alone (ASTS-SA) (K200002)<br>• Stryker Tritanium® C Anterior Cervical Cage (K171496) |
| Device Description: | The purpose of this Traditional 510(k) submission is to introduce the<br>Monterey™ AL Interbody System, a new anterior lumbar interbody fusion<br>device (IBD) product line.<br>These cages consist of a unique configuration of both solid and porous<br>structures that are simultaneously built using Laser Rapid Manufacturing<br>(LRM) method applying Stryker's proprietary Tritanium® In-Growth<br>Technology. The cage has two designs: a stand-alone cage which includes<br>screw holes for integrated fixation, and a spacer for use with external<br>supplemental fixation. The cage is offered in a variety of heights, depths,<br>widths, and lordotic angles to adapt to a variety of patient anatomies. It has |
| 510(k) Summary: Monterey™ AL Interbody System | |
| | biological fixation and to maximize surface area for endplate contact with the implant. The subject cages are wedge-shaped, featuring a tapered posterior edge for ease of pre-positioning and insertion into the disc space. The cages also contain a large central space for graft containment, as well as 2 lateral windows for graft visualization. |
| | The Monterey™ AL cages and screws are manufactured out of Ti6Al4V.<br>Cages: Ti6Al4V (ASTM F1472, ISO 5832-3, ASTM F136) Screws: Ti6Al4V (ISO 5832-3, ASTM F136) |
| Indications for Use: | Monterey™ AL Interbody System – Stand-Alone<br>The Stryker Spine Monterey™ AL Interbody System - Stand-Alone (AL Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.<br>DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.<br>Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.<br>The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.<br>The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation).<br>Monterey™ AL Interbody System – Spacer<br>The Stryker Spine Monterey™ AL Interbody System – Spacer (AL Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. |
| 510(k) Summary: Monterey™ AL Interbody System | |
| | DDD is defined as back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies. These DDD patients may also<br>have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).<br>These patients should be skeletally mature and have six months of non-<br>operative therapy. |
| | Additionally, the Monterey™ AL Spacer System can be used as adjunct to<br>fusion in patients diagnosed with degenerative scoliosis. |
| | The Monterey™ AL Spacer System is intended to be implanted via an anterior<br>approach. |
| | The Monterey™ AL Spacer System is intended to be used with supplemental<br>fixation systems that have been cleared by the FDA for use in the lumbosacral<br>spine. |
| Summary of the<br>Technological<br>Characteristics | The subject Monterey™ AL Interbody System was demonstrated to be<br>substantially equivalent to the identified predicate devices based on<br>material, design features, fundamental scientific technology, and mechanical<br>performance. |
| Summary of the<br>Performance Data | Testing in accordance with FDA's June 12, 2007 "Class II Special Controls<br>Guidance Document: Intervertebral Body Fusion Device" was performed for<br>the subject Monterey™ AL Cages and demonstrated substantially equivalent<br>performance to the identified predicate devices. The following mechanical<br>tests were performed:<br>• Static and Dynamic Compression (per ASTM F2077-18)<br>• Static and Dynamic Compression Shear (per ASTM F2077-18)<br>• Static Torsion (per ASTM F2077-18)<br>• Expulsion<br>• Subsidence (per ASTM F2267-04)<br>• Wear Particulate Analysis (per ASTM F1877-16)<br>• Impaction<br>• Screw Push Out<br>• Screw Pull Through |
| Conclusion | Based on the design features, the use of established well known materials,<br>feature comparisons, indications for use, and results of the mechanical<br>testing, the Monterey™ AL Cage has demonstrated substantial equivalence to<br>the identified predicate devices. |
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Part 1 — Search, results, and everyday workflows 16 min
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
