K132502 · Stryker Trauma AG · HRS · Oct 23, 2013 · Orthopedic
Device Facts
Record ID
K132502
Device Name
VARIAX 2 SYSTEM
Applicant
Stryker Trauma AG
Product Code
HRS · Orthopedic
Decision Date
Oct 23, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Stryker VariAx 2 System is intended for internal bone fixation in adult patients. The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for: - Internal fracture fixation; - Osteotomies; - Revision procedures such as non-unions or mal-unions; In addition, the following indications are specific to the devices listed below: - T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of: - Compression fractures; - Intra-articular and extra-articular fractures; - Displaced fractures; - Reconstruction procedures; - T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of: - Intra-articular and extra-articular fractures of the Distal Radius, - Displaced and compression fractures of the Distal Radius; - Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; - Reconstruction procedures in the Foot & Ankle and Distal Radius; - T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of: - Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; - Single, segmental and comminuted fractures; - Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; - Normal bone density or osteopenic bone.
Device Story
Internal bone fixation system consisting of metallic screws and instrumentation; used with previously cleared VariAx Plating Systems or independently via lag screw technique. Operates as mechanical fixation hardware for bone fractures, osteotomies, and revisions. Used by orthopedic surgeons in clinical settings. Provides structural stability to bone segments to facilitate healing. Available sterile and non-sterile.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Metallic bone fixation screws and instrumentation. Materials and design characteristics are substantially equivalent to predicate VariAx systems. Mechanical performance verified via standardized bench testing protocols.
Indications for Use
Indicated for internal fracture fixation, osteotomies, and revision procedures (non-unions/mal-unions) in adult patients. Specific indications include compression, intra-articular, extra-articular, displaced, single, segmental, and comminuted fractures, as well as replantation, joint fusions, arthrodesis, and reconstruction in small bones (distal radius, ulna, clavicle, humerus, foot, ankle, distal tibia, fibula). Applicable to normal or osteopenic bone.
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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#### 510(k) Summary
Proprietary Name: VariAx 2 System
Common Name: Bone Screws
Classification Name and Reference:
Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030
Smooth or threaded metallic bone fixation fastener 21 CFR §888.3040
Regulatory Class:
Class II
Product Codes:
Sponsor:
Contact Person:
HRS: Plate, Fixation, Bone HWC: Screw, Fixation, Bone HTN: Washer, Bolt Nut
Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland
Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 elijah.wreh@stryker.com Phone: 201-831-5691 Fax: 201-831-4691
Date Prepared:
August 7, 2013
#### Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the VariAx 2 System. The VariAx 2 System is an internal fixation device consisting of screws and instrumentation that will be used in conjunction with previously cleared VariAx Plating Systems to treat a number of different types of fractures in the radius, ulna, humerus, clavicle, foot, and fibula. These screws can be used in conjunction with said plating systems, or in the case of non-locking screws, may also be used independently using a lag screw technique. The subject components will be available sterile and non-sterile.
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### Intended Use
The Stryker VariAx 2 System is intended for internal bone fixation in adult patients.
#### Indications
The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
- Internal fracture fixation; .
- Osteotomies: .
- Revision procedures such as non-unions or mal-unions; .
In addition, the following indications are specific to the devices listed below:
- . T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
- Compression fractures: O
- O Intra-articular and extra-articular fractures;
- Displaced fractures; o
- Reconstruction procedures; O
- . T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, O
- Displaced and compression fractures of the Distal Radius; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Reconstruction procedures in the Foot & Ankle and Distal Radius; o
- T 10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and . Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; O
- Single, segmental and comminuted fractures; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Normal bone density or osteopenic bone. 0
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## Summary of Technologies
Device comparison showed that the proposed device is substantially equivalent in intended use, materials
and performance characteristics to the following predicate devices:
# Table 1: Predicate devices
| 510(k) Number | |
|---------------|---------------------------------------------------------------------------------------|
| K080667 | VariAx Distal Radius Torx Screws |
| K100271 | VariAx Distal Radius Line Extension of XXL Plates |
| K063875 | Stryker Foot Plating System |
| K081284 | VariAx Distal Fibula Plate |
| K102282 | VariAx Locked Plating System Line Extension for Addition<br>of Fibula Straight Plates |
| K073527 | VariAx Elbow System |
| K101056 | VariAx Elbow System |
| K113760 | VariAx Clavicle System |
| K130009 | VariAx 2 Compression Plating System |
| K000636 | Stryker Trauma Plating System |
# Non-Clinical Testing
Non-clinical laboratory testing was performed for the VariAx 2 System components to determine substantial equivalence. Testing demonstrated that the VariAx 2 System is substantially equivalent to the predicate devices currently cleared for marketing.
The following testing was performed
- . Screw Pull-Out Testing
- Screw Shear-Off Testing .
- . Screw Insertion Torque Testing
- . Static Cantilever Bending of Locking Mechanism
- . Dynamic Fatigue Plate-Screw Construct Testing
# Clinical Testing
Clinical testing was not required for this submission.
# Conclusion
The VariAx 2 System is substantially equivalent to the predicate devices identified in this premarket notification.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2013
Stryker Trauma AG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K132502
Trade/Device Name: VariAX 2 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, HTN Dated: August 7, 2013 Received: August 9, 2013
Dear Mr. Wreh:
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. Iisting 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
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Page 2 - Mr. Elijah N. Wreh
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
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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): _ K132502
Device Name: VariAx 2 System
Indications for Use:
The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
- Internal fracture fixation: ●
- . Osteotomies;
- Revision procedures such as non-unions or mal-unions; ●
In addition, the following indications are specific to the devices listed below:
- T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the . Distal Radius, in the treatment of:
- Compression fractures; O
- Intra-articular and extra-articular fractures; 0
- Displaced fractures; 0
- Reconstruction procedures; 0
- � T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, O
- Displaced and compression fractures of the Distal Radius; 0
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; 0
- o Reconstruction procedures in the Foot & Ankle and Distal Radius:
- T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and o Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna: 0
- 0 Single, segmental and comminuted fractures;
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle: 0
- Normal bone density or osteopenic bone. o
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
# Elizabeth L. Frank -S
Division of Orthopedic Devices
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.
