K080568 · Depuy Spine, Inc. · MQP · May 1, 2008 · Orthopedic
Device Facts
Record ID
K080568
Device Name
X-MESH EXPANDABLE CAGE SYSTEM
Applicant
Depuy Spine, Inc.
Product Code
MQP · Orthopedic
Decision Date
May 1, 2008
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3060
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The X-MESH™ Expandable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The X-MESH™ Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The X-MESH™ Expandable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The X-MESH™ Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™, M-2 ANTERIOR PLATE™, ISOLA®, VSP®, MOSS®MIAMI, TIMX™, MONARCH™, EXPEDIUM™, VIPER™, PROFILE™).
Device Story
X-MESH Expandable Cage System is a spinal vertebral body replacement device. It features three approach-specific shapes (anterior lateral, direct anterior, posterior) with rough, convex endplates and spikes for anchoring to resist migration and rotation. The cage includes diamond-pattern side slots and large graft windows for bone graft material. It is axially expandable and includes a setscrew for locking the expanded position. The device is implanted by a surgeon to replace diseased or fractured vertebral bodies in the thoracolumbar spine. It functions to restore biomechanical integrity of the spinal column and must be used in conjunction with supplemental internal fixation systems (e.g., titanium plates or rods).
Clinical Evidence
Bench testing only. Performance data were submitted to characterize the device's biomechanical integrity and functional performance.
Technological Characteristics
Manufactured from ASTM F 136 implant grade titanium alloy. Features an axially expandable cage design with a setscrew locking mechanism, rough convex endplates with spikes, and graft windows. Designed for anterior, anterior-lateral, or posterior surgical approaches in the thoracolumbar spine.
Indications for Use
Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor resection/excision or thoracic/lumbar fractures. Used to achieve anterior decompression and restore vertebral height. Requires use with supplemental internal fixation.
Regulatory Classification
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
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K080568
## 510(K) SUMMARY 6.
MAY - 1 2008
| <b>Submitter:</b> | DePuy Spine, Inc. |
|-------------------|---------------------|
| | 325 Paramount Drive |
| | Raynham, MA 02767 |
| Contact Person: | Hande Tufan<br>Senior Regulatory Affairs Associate |
|-----------------|----------------------------------------------------|
| Voice: | 508-828-3065 |
| Fax: | (508) 828-3797 |
| E-Mail: | ftufanya@dpyus.jnj.com |
February 28, 2008 Date Prepared:
Device Class: Class П
Classification Name: Spinal Vertebral Body Replacement Device
Classification Panel: Orthopedics
FDA Panel Number: 87
| Product Code(s): | MQP |
|--------------------|---------------------------------------------------------------------|
| Proprietary Name: | X-MESHTM Expandable Cage System |
| Predicate Devices: | Surgical Titanium Mesh (K030249)<br>Stackable Cage System (K013382) |
Device Description: The X-MESH™ Expandable Cage System comes in three approach-specific shapes for the anterior lateral, direct anterior and posterior approaches. Each cage comes fully assembled with rough, convex endplates containing spikes that help anchor the device in the vertebral endplates, and provide resistance to migration and rotation. This mesh cage contains diamond pattern, side slots and large graft windows for graft material. The cage can be expanded axially and has a setscrew for locking it in position.
- The X-MESH™ Expandable Cage System is indicated for Intended Use: use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
Doep
Page 6-1
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080568
The X-MESHT™ Expandable Cage System is also indicated
for treating fractures of the thoracic and lumbar spine.
The X-MESHT™ Expandable Cage System is designed to
restore the biomechanical integrity of the anterior, middle
and posterior spinal column even in the absence of fusion
for a prolonged period.
The X-MESHT™ Expandable Cage System is intended for
use with supplemental internal fixation. The supplemental
internal fixation systems that may be used include titanium
plate or rod systems (i.e., KANEDATM SR, UNIVERSITY
PLATETM, M-2 ANTERIOR PLATET™, ISOLA®, VSP®,
MOSS®MIAMI, TIMXTM, MONARCHTM, EXPEDIUMTM,
VIPERTM, PROFILETM).
**Materials:** Manufactured from ASTM F 136 implant grade titanium
alloy.
**Performance Data:** Performance data were submitted to characterize the
subject X-MESHT™ Expandable Cage System.
DePuy Spine, Inc., a Johnson & Johnson Company
2 82
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2008
DePuy Spine, Inc. % Mr. Hande Tufan Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, MA 02767
Re: K080568 Trade/Device Name: X-MESH™ Expandable Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 2, 2008 Received: April 3, 2008
Dear Mr. Tufan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Hande Tufan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## KOXOS68
## న. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: X-MESHTM Expandable Cage System
Indications For Use:
The X-MESH™ Expandable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The X-MESH™ Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.
The X-MESH™ Expandable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The X-MESH™ Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™ M-2 ANTERIOR PLATE™ . ISOLA® . VSP®, MOSS®MIAMI, TiMX™, MONARCH™ EXPEDIUM™, VIPER™, and PROFILE™).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| DePuy Spine, Inc., a Johnson & Johnson Company | |
| 510(k) Number | K080568 |
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
