The CerviFix System is indicated for the following: - DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies - Spondylolisthesis - Spinal stenosis - Fracture/dislocation - Atlantoaxial fracture with instability - Occipitocervical dislocation - Revision of previous cervical spine surgery - Tumors The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical spine and occipitocervical junction (occiput - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The CerviFix System can also be linked to the Synthes Universal Spine System using the 3.5/6.0mm parallel connectors from that system.
Device Story
Synthes CerviFix System is a posterior spinal fixation construct consisting of rods, plate/rods, hooks, bone screws, and connectors. Used by surgeons in clinical settings to stabilize the cervical spine and occipitocervical junction (Occiput-T3) to promote fusion. Components are manually assembled: rods are cut to length, inserted into hooks or plate/rods, and secured with set screws. Plate/rods are bent to anatomy and fixed to the occiput with screws; hooks attach to the cervical spine. System can link to Synthes Universal Spine System via parallel connectors. Provides mechanical stabilization following trauma, fracture, or degenerative conditions; benefits patient by maintaining alignment during bone fusion process.
Clinical Evidence
Bench testing only. Mechanical performance documented in accordance with ASTM standard F1717, confirming static and fatigue characteristics satisfy requirements for posterior occipitocervical and upper thoracic (Occiput-T3) fixation.
Technological Characteristics
Materials: Titanium alloy TiAINb (ASTM F1295) for rods, plates, hooks, connectors; Commercially pure grade 4 Titanium (ASTM F67) for bone screws. Components: 3.5mm diameter rods, plate/rods, hooks, trans-connector clamps, parallel connectors. Fixation: Mechanical set-screw locking mechanism. Connectivity: Compatible with Synthes Universal Spine System via 3.5/6.0mm parallel connectors.
Indications for Use
Indicated for patients requiring stabilization to promote fusion of the cervical spine and occipitocervical junction (Occiput-T3) due to DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, or tumors.
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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13991089 Synthes CerviFix System Special 510(k) Premarket Notification - Device Line Extension
Summary of Safety and Effectiveness Information
[510(k) Summary]
AUG 27 1999
SYNTHES (U.S.A.) 1690 Russell Road
Paoli, PA 19301
(610) 647-9700 Contact: Jonathan Gilbert 03/30/99
Device: SYNTHES CerviFix System consists of rods, plate/rods, hooks, bone screws, parallel connectors, trans-connector clamps, parallel connectors and set screws. These components are manufactured from the titanium alloy TiAINb (ASTM F1295). The bone screws are composed of commercially pure grade 4 Titanium (ASTM F67).
The CerviFix System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies
- Spondylolisthesis .
- Spinal stenosis .
- . Fracture/dislocation
- Atlantoaxial fracture with instability .
- Occipitocervical dislocation ●
- Revision of previous cervical spine surgery .
- . Tumors
The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical spine and occipitocervical junction (occiput - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The CerviFix System can also be linked to the Synthes Universal Spine System using the 3.5/6.0mm parallel connectors from that system.
The rods are 3.5mm in diameter and are offered in four lengths, 80, 120, 240 and 300mm. The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod or plate/rod/hook construct. In addition, trans-connector clamps are available in a left and right version. A 3.5mm/3.5mm parallel rod connector is offered with the system. The occipital bone screws are provided in the following configurations: a 3.2mm cortex screw, a 3.5mm cancellous screw, or a 4.0mm cancellous screw.
The device functions as follows: For non occipitocervical fusion, the end of the rod, cut to an appropriate length, is inserted into the rod opening of the hooks and loosely tightened into position with the set screws included in the hooks. The construct is then positioned under the laminae of the spinal segments to be instrumented. Once the construct is compressed together, the set screws are locked down to the rod. For occipitocervical fusion, the plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.
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To add a trans-connector construct, a 3.5 mm rod is cut to fit across two longitudinallyplaced 3.5 mm rods. Once the trans-connector clamps are attached to the longitudinal rods and transverse rod, the set screws are locked down to the rods. To use the parallel rod connector, two rods are inserted into the rod openings of the connector and the set screws are locked down to the rods.
The construct can also be linked to the 6.0mm diameter rods of the Universal Spine System (USS) using 3.5mm/6.0mm parallel connectors.
Mechanical testing was previously performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics and demonstrated that the performance characteristics satisfy the requirements of posterior occipitocervical and upper thoracic (Occiput-T3) fixation.
Material composition is identical to numerous other Synthes Spinal products that have been cleared via the 510(k) process. The methods for use and instrumentation to implant this system is similar to that of the Synthes CerviFix Systems, K984722.
Based on the above, the Synthes Spine CerviFix System is substantially equivalent to components cleared in previously cleared Synthes premarket submissions.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized human figure with three wavy lines above it, possibly representing support or care.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Mr. Jonathan Gilbert Senior Regulatory Affairs Associate Synthes Spine P.O. Box 0548 Paoli. Pennsylvania 19301
Re: K991089 Trade Name: CerviFix System Regulatory Class: II Product Code: KWP Dated: July 1, 1999 Received: July 2, 1999
Dear Mr. Gilbert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 – Mr. Jonathan Gilbert
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Num C. J. Rogers
ﺮﺓ - Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): NA
Device Name: Synthes CerviFix System
Indications for Use:
The CerviFix System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient ● history and radiographic studies
- Spondylolisthesis ●
- Spinal stenosis .
- Fracture/dislocation .
- Atlantoaxial fracture with instability ●
- Occipitocervical dislocation ●
- Revision of previous cervical spine surgery .
- Tumors .
The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical rnic oci in ix i later rous light - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The CerviFix System can also be linked to the Synthes Universal Spine System using the 3.5/6.0mm parallel connectors from that system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ***_*** OR Over-the-Counter Use **_** (Per 21 CFR 801.109)
**(Division Sign-Off)**
Division of General Restorative Devices
**510(k) Number** K991089
RA-01 Pre-market Notification CerviFix
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.
