K062447 · Medtronic Sofamor Danek, Inc. · KWP · Oct 15, 2007 · Orthopedic
Device Facts
Record ID
K062447
Device Name
TRAVERSE OCT SPINAL FIXATION SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
Product Code
KWP · Orthopedic
Decision Date
Oct 15, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3050
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSE™ Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Screws/Connectors The use of screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
Device Story
Posterior spinal fixation system; provides immobilization and stabilization as adjunct to fusion of cervical and upper thoracic spine (C1-T3). Components include rods, hooks, screws, and connecting components; tailor-made constructs for individual cases. Titanium ATLAS® cable may be used for attachment. Used by surgeons in clinical/OR settings. Output is a rigid construct providing mechanical stabilization to promote bone fusion. Benefits include stabilization of spinal segments in patients with degenerative or traumatic conditions.
Clinical Evidence
Bench testing only. Testing included compression fatigue, static compression, and static torsion to demonstrate mechanical equivalence to the predicate GALAXY™ 3.2 Spinal System.
Technological Characteristics
Constructed from medical grade titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Offset connectors include silicone adhesive elastomeric stakes. System is a posterior spinal fixation orthosis. No energy source or software components.
Indications for Use
Indicated for patients requiring cervical and thoracic (C1-T3) spinal fusion due to DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, or tumors. Screws restricted to T1-T3; not for cervical spine use.
Regulatory Classification
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
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# TRAVERSE™ Spinal Fixation System 510(k) Summary - K062447
CCT 1 5 2007
September 2007
| I. | Company: | Medtronic Sofamor Danek USA |
|----|----------|-----------------------------|
| | | 1800 Pyramid Place |
| | | Memphis, Tennessee 38132 |
| | | Telephone: (901) 396-3133 |
| | | Fax: (901) 346-9738 |
| | Contact: | Raphael McInnis |
Regulatory Affairs Specialist
### II. Proposed Proprietary Trade Name: TRAVERSE™ Spinal Fixation System
- Classification Name(s): Spinal Interlaminal Fixation Orthosis; Spinal Intervertebral Body III. Fixation Orthosis; Pedicle Screw Spinal System; Orthosis, Spinal Pedicle Fixation, for Degenerative Disc Disease; Class: II; Product Code(s): KWP,MNI; and Regulation No .: 888.3050 and 888.3070
- IV. Legally Marketed Devices: GALAXY™ 3.2 Spinal System (K043020)
- V. Description: The TRAVERSE™ Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.
The TRAVERSE™ Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both systems for labeling limitations.
The TRAVERSE™ Spinal Fixation System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, medical grade titanium alloy and/or medical grade cobalt-chromium-molybdenum allov may be used together. Never use titanium alloy and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Lastly, the offset connectors contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
- VI. Indications for Use: When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSE™ Spinal Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
### Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
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### Screws/Connectors
The use of screws is limited to placement in T1-T3 only. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
- VII. Substantial Equivalence: The TRAVERSE™ Spinal Fixation System is substantially equivalent to the GALAXY™ 3.2 Spinal System (K043020, SE 01/07/05). Performance bench testing performed for the TRAVERSE™ Spinal Fixation System includes compression fatigue, static compression, and static torsion. The purpose of this testing was to support substantial equivalence to the aforementioned GALAXY™ 3.2 Spinal System. The results of the testing performed on the TRAVERSE™ Spinal Fixation System were equivalent or better than the commercially available GALAXY™ 3.2 Spinal System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2007
Medtronic, Inc. c/o Mr. Raphael McInnis Regulatory Affairs Specialist 1800 Pyramid Place Memphis, TN 38132
Re: K062447
Trade/Device Name: TRAVERSE™ Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: September 28, 2007 Received: October 1, 2007
Dear Mr. McInnis:
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. Raphael McInnis
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" (21 CFR 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 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) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jarlau BuchnD
MLN. M. W.
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### CONFIDENTIAL
### 510(k) Number (if known): K062447
Device Name: TRAVERSE™ Spinal Fixation System
### Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSETM Spinal Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
### Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
### Screws/Connectors
The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
AND/OR Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Aubare Buchan Johnson
and Neurological Devices
510(k) Number_K062447
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.
