The subject components. Osteonics® Spinal System Versatile Cross Connector, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System are as follows: As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for: Long and short curve scoliosis . . Vertebral fracture or dislocation . Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies). . Previously failed fusion . Spinal tumor Pedicular Use: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.
Device Story
Osteonics Spinal System Versatile Cross Connector is a spinal fixation component used to join spinal constructs on opposite sides of the spine. It provides additional stability and resistance to lateral loads, rotation, and torsional movements. The device is intended for use by surgeons in spinal procedures. It is a single-use, non-sterile implant made of titanium alloy. The surgeon integrates the connector into the existing spinal construct to enhance structural integrity, potentially benefiting the patient by supporting fusion and stabilizing the spine.
Clinical Evidence
Bench testing only; no clinical data presented. Fatigue and static testing were performed to demonstrate mechanical and endurance properties equivalent to predicate devices.
Technological Characteristics
Material: ASTM F-136 Titanium alloy (Ti-6AI-4V ELI). Form factor: Spinal fixation cross-connector. Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile (intended for sterilization by user).
Indications for Use
Indicated for patients with scoliosis, vertebral fracture/dislocation, spondylolisthesis, degenerative disc disease, failed fusion, or spinal tumor (T4-S2). Pedicular use indicated for skeletally mature patients with degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, or failed fusion. Severe spondylolisthesis (Grades 3-4) at L5-S1 indicated for pedicle fixation with autogenous bone graft.
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.
Predicate Devices
CD Horizon™ Low Profile Crosslink® Multi-Span™ Plates (Sofamor Danek)
Multi Axial Low Profile Crosslink® Multi-Span™ Plates (Sofamor Danek)
Submission Summary (Full Text)
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2 1999 JUN
K990922
510(k) Summary
Osteonics Spinal System Versatile Cross Connector
# 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® SPINAL SYSTEM VERSATILE CROSS CONNECTOR
#### Submission Information
| Name and Address of the Sponsor of the 510(k) Submission: | Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677<br>201-825-4900 |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Ariemma<br>Regulatory Affairs Specialist |
| Date Summary Prepared: | March 17, 1999 |
| Device Identification | |
| Proprietary Name: | Osteonics <sup>®</sup> Spinal System Versatile Cross Connector |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis<br>21 CFR §888.3050<br>Pedicle Screw System<br>21 CFR §888.0370 |
#### Predicate Device Identification
The Osteonics® Spinal System Versatile Cross Connector components are substantially equivalent to other legally marketed crosslinking (transversing) assembly components. These predicate components are part of the commercially available spinal systems stated below:
- · CD Horizon™ Low Profile Crosslink® Multi-Span™ Plates, Sofamor Danek
- · Multi Axial Low Profile Crosslink® Multi-Span™ Plates, Sofamor Danek
#### Device Description
The Osteonics® Spinal System is comprised of single use, non-sterile devices manufactured from ASTM F-136 Titanium alloy (Ti-6AI-4V ELI). The Osteonics® Spinal System Versatile Cross
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#### 510(k) Summary
Connector may be used in spinal applications where additional stability for the device construct is desired by the surgeon. The Osteonics Spinal System Versatile Cross Connector allows a spinal construct on one side of the spine to be joined to another construct on the other side of the spine. The joining is intended to provide additional resistance to physiological forces such as unequal lateral loads, rotation, and isolated torsional movements.
# Intended Use
The following are specific indications for the Osteonics Spinal System:
# As a non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis ●
- . Vertebral fracture or dislocation
- . Spondylolisthesis
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies).
- . Previously failed fusion
- Spinal tumor
### Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- . In addition, the Osteonics" Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.
# Statement of Technological Comparison
The components of the Osteonics® Spinal System Versatile Cross Connector share the same materials, intended uses and basic design concepts as that of the predicate devices. Fatigue and static testing demonstrates the mechanical and endurance properties of the subject components are within the range demonstrated by other existing spinal systems.
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Public Health Service
2 1999 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth A. Staub Vice President, Quality Assurance/Regulatory Compliance/Clinical Research Howmedica Osteonics® Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K990922
> Trade Name: Osteonics® Spinal System Versatile Cross Connector Regulatory Class: II Product Codes: KWP. MNH, and MNI Dated: March 17, 1999 Received: March 19, 1999
Dear Ms. Staub:
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 (OS) 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 - Ms. Elizabeth A. Staub
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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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# 510(k) Number (if known): K9909922
Device Name: Osteonics® Spinal System Versatile Cross Connector®
Indications For Use:
The subject components. Osteonics® Spinal System Versatile Cross Connector, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Osteonics® Spinal System.
The uses for the legally marketed Osteonics® Spinal System are as follows:
# As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis .
- . Vertebral fracture or dislocation
- . Spondylolisthesis
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies).
- . Previously failed fusion
- . Spinal tumor
### Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.
(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 Devices | |
| 510(k) Number | K99092 |
| Prescription Use | X | OR | Over-The-Counter Use | |
|------------------|---|----|----------------------|--|
|------------------|---|----|----------------------|--|
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
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.
