AxSOS 3 Ti is intended for long bone fracture fixation Indications include: Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures Non-unions and malunions Normal and osteopenic bone Osteotomies Periprosthetic fractures of the femur and proximal tibia. The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: Periprosthetic fractures Diaphyseal and metaphyseal areas of long bones in pediatric patients The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis. SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis of the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. SPS Basic Fragment Set The Basic Fragment Set is in long bone fracture fixation. Reconstruction plates. wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the fibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
Device Story
System comprises anatomically contoured monoaxial locking plates, screws, and blind screws; designed for long bone fracture fixation. Plates feature holes for locking/non-locking screws, suture, and K-wires. Used in clinical settings by orthopedic surgeons for internal bone fixation. Output is mechanical stabilization of bone fragments to facilitate healing. Submission establishes cross-compatibility between existing AxSOS 3 Ti and Stryker Plating System (SPS) components; no new implants introduced.
Clinical Evidence
No clinical data. Bench testing and engineering analysis performed to confirm cross-compatibility of components. Bacterial endotoxin testing (BET) conducted per ANSI/AAMI ST72:2011.
Technological Characteristics
Materials: Titanium alloy (Ti6Al4V) per ASTM F136 and stainless steel (316L). Components: Anatomically contoured monoaxial locking plates, locking/cortical/cancellous screws, blind screws. Features: Holes for locking/non-locking screws, suture, and K-wires. Sterilization: Sterile and non-sterile options. Connectivity: None.
Indications for Use
Indicated for long bone fracture fixation, including diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures, non-unions, malunions, osteotomies, and periprosthetic fractures in normal or osteopenic bone. Includes pediatric use for long bone diaphyseal/metaphyseal fractures and specific fixation for scapula, pelvis, and various small fragments (fibula, metatarsals, metacarpals, radius, ulna, humerus, clavicle, calcaneus).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2017
Stryker GmbH Irene Bacalocostantis Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K162439 Trade/Device Name: AxSOS 3 Ti; Stryker Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 4, 2017 Received: January 5, 2017
Dear Irene Bacalocostantis:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
# Vincent J. Devlin -S
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
510(k) Number (if known)
(page 1 of 2) K162439
Device Name AxSOS 3 Ti
Indications for Use (Describe)
AxSOS 3 Ti is intended for long bone fracture fixation Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions and malunions
- · Normal and osteopenic bone
- · Osteotomies
- · Periprosthetic fractures of the femur and proximal tibia.
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- · Periprosthetic fractures
- · Diaphyseal and metaphyseal areas of long bones in pediatric patients
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
Type of Use (Select one or both, as applicable)
| <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;"><span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
K162439 (page 2 of 2)
Device Name
Stryker Plating System
Indications for Use (Describe)
SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis of the diaphysis of the following:
- · One third tubular plate: fibula, metatarsals, metacarpals
- · Fibular plate: fibula
- · Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle
- · Oblique T-plate: distal radius
- · T-plate: distal radius, calcaneus, lateral clavicle
- · Cloverleaf plate: proximal humerus, distal tibia
- · Calcaneal plate: calcaneus
· Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set The Basic Fragment Set is in long bone fracture fixation. Reconstruction plates. wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the fibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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# 510(k) Summary
| Proprietary Name: | AxSOS 3 Ti<br>Stryker Plating System |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Plates<br>Bone<br>Screws |
| Regulation Number &<br>Regulation Description: | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories. |
| | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Product Code: | HRS (Plate, Fixation, bone)<br>HWC (Screw, Fixation, Bone/Washer) |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH<br>Bohnackerweg 1<br>2545 Selzach / Switzerland |
| Contact Person: | Irene Bacalocostantis Ph.D.<br>Sr. Regulatory Affairs<br>Specialist 325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: (201) 831-6797 |
| Date Prepared: | February 2, 2017 |
| Predicate Devices: | AxSOS 3 Ti (K153379)<br>Stryker Plating System (K060798) |
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# Description
The AxSOS 3 Ti system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws. The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirshner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components come sterile and non-sterile.
The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set consists of plates and screws for fixation of fractures of the cortical and metaphyseal area of the long bone as well as fracture of the pelvis. The implant set is available in either in stainless steel (316 L) or titanium alloy (Ti6Al4V).
This submission is not intended to introduce any new implants into the system, but rather to demonstrate compatibility between the AxSOS 3 Ti system (K153379) and several of the titanium screw/plate components found in the Stryker Plating System (SPS) most recently cleared in K060798. The AxSOS 3 Ti plates and screws are manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and available sterile and non-sterile.
# AxSOS 3 Ti
Indications For Use
AxSOS 3 Ti is intended for long bone fracture fixation Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- Non-unions and malunions ●
- Normal and osteopenic bone ●
- Osteotomies ●
- Periprosthetic fractures of the femur and proximal tibia. .
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- Periprosthetic fractures ●
- Diaphyseal and metaphyseal areas of long bones in pediatric patients ●
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
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# Stryker Plating System
Indications for Use:
SPS Small Fragment Set The Stryker® Plating System,
Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:
- One third tubular plate: fibula, metatarsals, metacarpals ●
- Fibular plate: fibula ●
- Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle ●
- Oblique T-plate: distal radius ●
- T-plate: distal radius, calcaneus, lateral clavicle ●
- Cloverleaf plate: proximal humerus, distal tibia
- Calcaneal plate: calcaneus ●
- Reconstructive plate: humerus, pelvis Screws are used either to fasten plates . or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, Tbuttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
## Summary of Technologies
There are no changes to the design or technological characteristics of the AxSOS 3 Ti system implants, nor in the Stryker Plating System.
## Non-Clinical Testing
Bench testing and an engineering analysis were provided to demonstrate compatibility between components.
Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of ‹ 20EU/Device.
## Clinical Testing
Clinical testing was not required for this submission.
## Conclusion
There have not been any changes or component additions to the AxSOS 3 Ti system. A bench testing and engineering analysis show that several of the plate and screw components in the AxSOS 3 Ti and Stryker Plating System are cross-compatible. The cross-compatibility between the AxSOS 3 Ti System and Stryker Plating System are found in the operative technique guides.
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.
