Xenco Medical InterAlign Cervical Interbody System
K223059 · Xenco Medical, LLC · OVE · Jun 7, 2023 · Orthopedic
Device Facts
Record ID
K223059
Device Name
Xenco Medical InterAlign Cervical Interbody System
Applicant
Xenco Medical, LLC
Product Code
OVE · Orthopedic
Decision Date
Jun 7, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
When used as an intervertebral fusion device with bone graft, cervical: Xenco Medical IntelAlign Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device. The device is intended to be used with supplemental fixation (e.g. anterior plate system). When used as an intervertebral fusion device w/ integrated fixation, cervical (interbody spacer w/ provided plate, bone screws, and locking cover): Xenco Medical IntelAlign Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Xenco Medical IntelAlign Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical IntelAlign Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.
Device Story
Intervertebral body fusion system; box-shaped spacers with surface teeth and central channel for autogenous bone graft; used for spinal fusion at one cervical level (C3-C7). Implanted via open, anterior approach. Available as stand-alone construct (with integrated fixation plate, bone screws, and locking cover) or for use with supplemental fixation. Used by surgeons in clinical settings. Implants provide structural support to facilitate fusion; radiographic markers assist visualization. System includes single-use sterile instruments.
Clinical Evidence
Bench testing only. Implants are identical to those cleared in K160313; no new performance testing required. Instrumentation manufactured identically to reference device (K112913); no new biocompatibility testing required. Gamma sterilization validation performed.
Indicated for skeletally mature patients with degenerative disc disease (discogenic neck pain) at one level (C3-C7) of the cervical spine, following at least six weeks 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.
DePuy Spine, Inc. Spotlight Access System (K112913)
Submission Summary (Full Text)
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June 7, 2023
Xenco Medical, LLC % Linda Braddon, Ph.D. CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K223059
Trade/Device Name: Xenco Medical InterAlign Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: May 10, 2023 Received: May 12, 2023
Dear Dr. Braddon:
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Brent Showalter -S
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
510(k) Number (if known) K223059
#### Device Name
Xenco Medical InterAlign Cervical Interbody System
#### Indications for Use (Describe) When used as an intervertebral fusion device with bone graft, cervical:
Xenco Medical InterAlign Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).
When used as an intervertebral fixsion, cervical (interbody spacer w/ provided plate, bone screws, and locking cover):
Xenco Medical InterAlign Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xeno Medical InterAlign Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical InterAlign Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------|--------------------------------------------------|
| \[X] Prescription Use (Part 21 CFR 801 Subpart D) | \[ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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| <b>510(k) SUMMARY:</b> |
|----------------------------------------------------|
| Xenco Medical IntelAlign Cervical Interbody System |
| Date Prepared | May 31, 2023 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Xenco Medical, LLC |
| | Jason Haider, Founder and CEO |
| | 9930 Mesa Rim Rd |
| | San Diego, CA 92121 |
| | 858-202-1522 ext. 202 |
| | jhaider@xencomedical.com |
| 510(k) Contact(s) | Secure BioMed Evaluations |
| | Linda Braddon, Ph.D. |
| | Justin Gracyalny, MSE |
| | 7828 Hickory Flat Highway<br>Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>Regulatory@SecureBME.com |
| | |
| Trade Name | Xenco Medical IntelAlign Cervical Interbody System |
| Code –<br>Classification | Classification Name: Intervertebral body fusion device (21 CFR 888.3080) |
| | Regulatory Class: Class II<br>Product Code: OVE, ODP |
| Primary Predicate<br>Device | K160313 Xenco Medical Cervical Interbody System |
| Additional Predicate<br>Device | K140786 Xenco Medical Cervical Interbody System |
| Reference Device | K112913 DePuy Spine, Inc. Spotlight Access System |
| Device Description | Xenco Medical IntelAlign Cervical Interbody System devices are generally<br>box shaped with surface teeth and a central channel for packing autogenous<br>bone. These implants are available in a range of shapes and sizes to<br>accommodate variations in patient anatomy. Spacers are manufactured from<br>PEEK polymer (Zeniva ZA-500 per ASTM F2026) and contain titanium (per<br>ASTM F67), titanium alloy (per ASTM F1472), or tantalum (per ASTM F560)<br>markers to assist with radiographic visualization. Stand-alone device<br>constructs additionally utilize a fixation plate and bone screws manufactured<br>from titanium alloy, and a PEEK locking cover. The system also includes<br>instruments manufactured using anodized 6061 T6 aluminum alloy per ASTM<br>B211 / B221. All system implants and instruments are provided sterile<br>packaged and are intended for single use. |
| Indications for Use<br>Statement | When used as an intervertebral fusion device with bone graft, cervical:<br>Xenco Medical IntelAlign Cervical Interbody System devices are intended for<br>spinal fusion procedures at one level (C3-C7) in skeletally mature patients<br>with degenerative disc disease (defined as neck pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies) of the<br>cervical spine. Devices are to be implanted via an open, anterior approach and<br>packed with autogenous bone. Patients should have had at least six weeks of<br>non-operative treatment prior to surgical treatment with the device. The device<br>is intended to be used with supplemental fixation (e.g. anterior plate system).<br><br>When used as an intervertebral fusion device w/ integrated fixation, cervical<br>(interbody spacer w/ provided plate, bone screws, and locking cover):<br>Xenco Medical IntelAlign Cervical Interbody System constructs are stand-<br>alone anterior cervical interbody fusion devices intended for use as an adjunct<br>to fusion at one level (C3-C7) in skeletally mature patients with degenerative<br>disc disease (defined as discogenic neck pain with degeneration of the disc<br>confirmed by history and radiographic studies). Patients should have received<br>at least six weeks of non-operative treatment prior to treatment with the<br>device. Xenco Medical IntelAlign Interbody System constructs are to be<br>packed with autogenous bone graft and implanted via an open, anterior<br>approach. Xenco Medical IntelAlign Cervical Interbody System constructs are<br>intended to be used with the plate, bone screws, and locking cover provided<br>and require no additional fixation. |
| Technological<br>Characteristics | There are no significant technological differences between the subject and<br>predicate device. The subject device implants are identical to those of the<br>primary predicate (K160313). The only difference between the subject and<br>predicate device is the material of manufacture for the instrumentation which<br>is identical to the reference device (K112913). As supported by the non-<br>clinical performance testing, this difference does not raise new concerns for<br>safety or effectiveness. |
| Performance<br>Testing | As the implants are identical to those cleared in K160313 and no changes have<br>been made to indications or claims, no new non-clinical performance testing<br>was required for the subject device implants. The subject device<br>instrumentation is manufactured identically to those described in the reference<br>device (K112913). As such, no biocompatibility testing was required to<br>support the change. A gamma sterilization validation was performed to<br>support the change in device material. |
| Conclusion | Based on the similarities of the intended use/indications for use, technological<br>and functional characteristic, and the results of the non-clinical performance<br>testing, the subject device is substantially equivalent to the legally marketed<br>predicate device. |
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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.
