K131724 · Pioneer Surgical Technology, Inc. · MQP · Dec 24, 2013 · Orthopedic
Device Facts
Record ID
K131724
Device Name
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
Applicant
Pioneer Surgical Technology, Inc.
Product Code
MQP · Orthopedic
Decision Date
Dec 24, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3060
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., Ti-1.5) 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 MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse VBR 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 MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental internal fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.
Device Story
MaxFuse VBR System is a radiolucent, multilevel corpectomy device used in thoracolumbar spine surgery. It replaces diseased or collapsed vertebral bodies to restore spinal column biomechanical integrity. The system features various footprints, heights, and lordotic angles to accommodate patient anatomy; it may be used with bone graft. It is intended for use with supplemental internal fixation systems (Quantum, Streamline TL, Streamline MIS). The device is implanted by a surgeon during spinal procedures to provide structural support and anterior decompression of neural tissues. It functions as a mechanical spacer to maintain height and stability, potentially benefiting patients by alleviating compression and restoring spinal alignment.
Clinical Evidence
Bench testing only. Performance established through side-by-side mechanical testing per ASTM F 2077 (static/dynamic axial compression, bending, torsion), ASTM F 2267 (static subsidence), and draft Z8423Z (static expulsion).
Technological Characteristics
Constructed from ASTM F 2026 PEEK with ASTM F 560 tantalum or ASTM F 136 titanium alloy radiographic markers. Single-unit VBR design with toothed surface for bone graft containment. Radiolucent material properties.
Indications for Use
Indicated for patients requiring thoracolumbar (T1-L5) vertebral body replacement due to tumor resection/excision or thoracic/lumbar fractures. Used to achieve anterior decompression and restore vertebral height. Requires use with cleared supplemental internal fixation systems.
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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K131724
DEC 2 4 2013
## ・ 510(k) SUMMARY
MaxFuse VBR System
| Sponsor: | Manufacturer/<br>(Owner): | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Phone:<br>Fax:<br>Official Contact: | (906) 225-5602<br>(906) 226-4459<br>Emily M. Downs<br>Sarah McIntyre |
| Device Name: | Date prepared: | December 19, 2013<br>MaxFuse Vertebral Body Replacement (VBR) System |
| Classification<br>Name: | Spinal Vertebral Body Replacement Device | |
| Classification: | 21 CFR 888.3060 - Product code MQP, Class II | |
| Predicate<br>Devices: | Pioneer Vertebral Spacer (K061151)<br>DePuy Spine Bengal Stackable Cage System (K073649)<br>NuVasive Mesh VBR (K032476) | |
| Description: | The MaxFuse VBR System is a radiolucent, multilevel corpectomy system<br>with VBR devices in a variety of footprint options, height options, and<br>lordotic angle options to accommodate a wide variety of patient anatomy.<br>The MaxFuse VBR devices may be used with bone graft. | |
| Intended Use: | The MaxFuse VBR System is indicated for use in the thoracolumbar spine<br>(i.e., Ti-1.5) to replace a diseased vertebral body resected or excised for the.<br>treatment of tumors, to achieve anterior decompression of the spinal cord and<br>neural tissues, and to restore the height of a collapsed vertebral body. The<br>MaxFuse VBR System is also indicated for treating fractures of the thoracic<br>and lumbar spine. The MaxFuse VBR System is designed to restore the<br>biomechanical integrity of the anterior, middle, and posterior spinal column<br>even in the absence of fusion for a prolonged period.<br><br>The MaxFuse VBR System is intended for use with supplemental internal<br>fixation systems cleared for the conditions listed above. The supplemental<br>internal fixation systems that may be used include the Quantum Spinal<br>Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS<br>Spinal Fixation System. | |
| Materials: | The MaxFuse VBR System implants are composed of ASTM F 2026<br>Polyetheretherketone (PEEK) with ASTM F 560 tantalum or ASTM F 136<br>titanium alloy radiographic markers. | |
| Performance Data: | Substantial equivalence was established through side-by-side testing to<br>legally markted predicate devices, including:<br>ASTM F 2077: Static and Dynamic Axial Compression Bending and<br>Static Torsion ASTM F 2267: Static Subsidence Draft Z8423Z, Submitted to ASTM F04.25.02.02: Static Expulsion | |
| Substantial<br>Equivalence: | The subject and predicate systems are overall similar in:<br>Intended Usc Basic design: Single-unit VBR with radiographic markers, toothed surface,<br>bone graft containment Materials: PEEK, Titanium alloy, Tantalum Sizes: Footprints, heights, lordosis comparable to predicates Mechanical Performance: equivalent results There are no significant differences between the subject MaxFuse VBR<br>System and the predicate devices which would adversely affect the use of the<br>product. This submission supports the position that the subject system is<br>substantially equivalent to previously cleared predicate systems. | |
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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 stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2013
Pioneer Surgical Technology, Incorporated Ms. Sarah McIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855
Re: K131724
Trade/Device Name: MaxFuse VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 25, 2013 Received: October 29, 2013
Dear Ms. McIntyre:
We have reviewed vour 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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### Page 2 - Ms. Sarah McIntyre
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
# Lori A. Wiggins
- for 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 Statement
### 510(k) Number (if known): K131724
Device Name: MaxFuse VBR System
Indications:
The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., TI-L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse VBR 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 MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.
Prescription Use V OR (Per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedia 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.
