The Osteo Compression Condyle Screw System is a distal fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur: Intercondylar fractures, Supracondylar fractures, and Unicondylar fractures.
Device Story
Distal femoral fracture fixation system; includes compression condyle plates, lag screws, and compression screws. Plates feature 95° barrel angle; accommodate 4.5mm cortical screws and 6.5mm cancellous screws. Lag screws are cannulated for guide wire use. System provides internal fixation to aid bone healing. Used in clinical/surgical settings by orthopedic surgeons. Provides stable fixation for fracture management; reduces soft tissue irritation.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and material comparison to predicate.
Technological Characteristics
Materials: ASTM F-138 Stainless Steel (Grade 2, 316LVM). Components: Compression condyle plates (95° barrel angle), lag screws (cannulated, 12.5mm diameter), and compression screws. Plates available in 6, 8, 10, 12 hole configurations. Non-sterile and sterile options.
Indications for Use
Indicated for patients with distal femur fractures, specifically intercondylar, supracondylar, and unicondylar fractures.
Regulatory Classification
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
Synthes Dynamic Condylar Screw System
Submission Summary (Full Text)
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K971321 । of 2
Osteo Compression Condyle Screw System
510(k) Premarket Notification
# 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO COMPRESSION CONDYLE SCREW SYSTEM
JUL - 9 1997
# Submission Information
Name and Address of the Sponsor Osteonics Corporation of the 510(k) Submission: 59 Route 17 Allendale, NJ 07401-1677 201-825-4900 Donna S. Wilson Contact Person: Regulatory Affairs Specialist April 9, 1997 Date Summary Prepared: Device Identification Osteo Compression Condyle Screw System Proprietary Name: Compression Condyle Plate and Screw Common Name: Single/Multiple Component Metallic Bone Classification Name and Reference: Fixation Appliances and Accessories 21 CFR §888.3030
#### Predicate Device Identification
The Osteo Compression Condyle Screw System is substantially equivalent to the Synthes® Dynamic Condylar Screw System.
## Device Description
The Osteo Compression Condyle Screw System is a distal femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues.
## Osteo Compression Condyle Plates:
The Osteo Compression Condyle Plates are part of the Osteo Compression Condyle Screw System. These plates are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile. The Osteo Compression Condyle Plates are available in four (4) sizes with varying lengths and number of screw holes (6, 8, 10, and 12) for varied clinical situations. All plates have a 25mm barrel length and autocompression holes for cortical
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#### Osteo Compression Condyle Screw System
screws with a 4.5mm diameter. The two screw holes closest to the barrel also accommodate cancellous screws with a 6.5mm diameter. The plates feature a 95° barrel angle. The barrel slides over the inserted lag screw; a compression screw may be used for additional compression of the fracture area.
#### Osteo Lag Screws:
The Osteo Lag Screws which are the included as part of this premarket notification are available in three lengths (50mm, 55mm, and 60mm). Osteo Lag Screws of longer lengths, up to 145mm, have been cleared under a previous premarket notification. The subject Osteo Lag Screws are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile and sterile. All lag screws have a 22mm thread length for maximum purchase, a thread diameter of 12.5mm, and a cannulated end for ease of use with guide instrumentation.
#### Intended Use
The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur: Intercondylar fractures, Supracondylar fractures, and Unicondylar fractures.
## Statement of Technological Comparison
The subject Osteo Compression Condyle Screw System components (compression condyle plates and lag screws) are substantially equivalent in design, materials, and intended use to the predicate devices offered by Synthes in their Dynamic Condylar Screw System.
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Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is black and is on a white background. The text is centered in the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna S. Wilson Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
JUL - 9 1997
Re : K971321 Osteo Compression Condyle Screw System Regulatory Class: II Product Codes: HRS and HWC Dated: April 9, 1997 Received: April 10, 1997
Dear Ms. Wilson:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Ms. Donna S. Wilson
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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 requlation (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
la 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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# 510(k) Number (if known): K 9 7 i 32 l
### Device Name: Osteo Compression Condyle Screw System
# Indications For Use:
-
The Osteo Compression Condyle Screw System-is a distal fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur:
- Intercondylar fractures .
- . Supracondylar fractures
- . Unicondylar fractures
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division | |
|---------------|---------------------|
| Division | testorative Devices |
| 510(k) Number | K971321 |
| Prescription Use | X | OR | Over-The-Counter Use |
|----------------------|---|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |
(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.
