The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins. The Extrafix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone ( foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for: - Temporary stabilization of open or closed acute fractures with soft tissue injuries; . - Definitive stabilization of open or closed fractures where open or alternative closed # treatment is undesirable or otherwise contraindicated; - Stabilization of fractures in the context of polytrauma; . - Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; - Arthrodesis and osteotomies with associated soft tissue problems; . - Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure; - Neutralization of fractures stabilized with limited internal fixation; . - Stabilization of non-unions; and - Intraoperative temporary stabilization tool to assist with indirect reduction.
Device Story
Extrafix External Fixation System is a modular orthopedic device used to construct external fixation frames. Components include clamps, posts, bars, and fixation pins. Used by surgeons in clinical settings (OR) to stabilize long bone and pelvic fractures. The device provides mechanical stabilization of bone segments; it is applied externally to the patient's limb or pelvis. By maintaining bone alignment and stability, the system facilitates healing in complex fracture cases, polytrauma, or post-infection joint arthroplasty removal. The surgeon manually assembles the frame components to the patient's anatomy to achieve the desired reduction and stabilization.
Clinical Evidence
Bench testing only. Evaluated according to ASTM F1541-02 (2007) Standard Specification and Test Methods for External Fixation Devices and FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices.
Technological Characteristics
Modular external fixation system consisting of clamps, posts, bars, and fixation pins. Evaluated per ASTM F1541-02 (2007). Mechanical fixation device; no energy source or software.
Indications for Use
Indicated for patients requiring external fixation for long bone (foot, femur, tibia) and pelvic fractures. Includes acute fractures with soft tissue injury, polytrauma, pelvic ring injuries, arthrodesis, osteotomies, post-arthroplasty limb stabilization, non-unions, and intraoperative reduction assistance.
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
Stryker Hoffmann II MRI External Fixation System (K053472)
Synthes Large External Fixation Clamps- MR S (K031428)
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# KO91258
## Extrafix External Fixation System 510(k) Summary
| Device Manufacturer: | QFX Technologies<br>8275 Tournament Drive, Suite 160<br>Memphis, TN 38125 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | July 15, 2009 |
| Contact Person: | Steve Miller<br>Tel: 1-831-331-5675<br>Fax: 1-831-440-9837 |
| Proprietary Name: | Extrafix External Fixation System |
| Common Name: | External Fixation Frame Components |
| Classification regulation: | 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories, 888.3040 Smooth or<br>threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Product Codes: | KTT and JDW |
#### Device Description and Intended Use:
The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.
The Extrafix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone ( foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
- Definitive stabilization of open or closed fractures where open or alternative closed # treatment is undesirable or otherwise contraindicated;
- Stabilization of fractures in the context of polytrauma; .
- Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries;
- Arthrodesis and osteotomies with associated soft tissue problems; .
- Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
- Neutralization of fractures stabilized with limited internal fixation; .
- Stabilization of non-unions; and
- Intraoperative temporary stabilization tool to assist with indirect reduction.
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## Extrafix External Fixation System 510(k) Summary
#### Predicate Devices:
The Extrafix External Fixation System is similar to several predicates including the following:
- Stryker Hoffmann II MRI External Fixation System (K053472); .
- Synthes Large External Fixation Clamps- MR S (K031428); and .
- Smith & Nephew Jet-X Unilateral Fixator (K994143). .
### Technological Characteristics
The Extrafix External Fixation System was characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2007), Standard Specification and Test Methods for External Fixation Devices and the FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices.
#### Substantial Equivalence Information:
The Extrafix External Fixation System is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the Extrafix External Fixation System is substantially equivalent to the predicate devices.
Pg 2 of 2
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
OFX Technologies, Inc. % M Squared Associates, Inc. Mr. Marcos Velez-Duran President 901 King Street, Suite 200 Alexandria, Virginia 22314
Re: K091258
9200 Corporate Boulevard Rockville MD 20850
Food and Drug Administration
JUL 2 4 2009
Trade/Device Name: Extrafix External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, JDW Dated: April 28, 2009 Received: April 29, 2009
Dear Mr. Velez-Duran:
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.
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 mav 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 device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Marcos Velez-Duran
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Chabare Buehrle
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# K091258
## Indications for Use Statement
510(k) Number: To be assigned
Device Name: Extrafix External Fixation System
Indications for Use: The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.
The Extrafix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:
- o Temporary stabilization of open or closed acute fractures with soft tissue injuries;
- Definitive stabilization of open or closed fractures where open or alternative closed 0 treatment is undesirable or otherwise contraindicated;
- Stabilization of fractures in the context of polytrauma: o
- Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; 0
- Arthrodesis and osteotomies with associated soft tissue problems; 0
- 0 Stabilization of limbs after removal of total joint (knee and ankle) arthroplasty for infection or other failure;
- Neutralization of fractures stabilized with limited internal fixation: o
- Stabilization of non-unions; and 0
- o Intraoperative temporary stabilization tool to assist with indirect reduction.
Prescription Use X
AND/OR
Over-The-Counter Use __
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smita for mum
(Division Sign-Off)
Division of Surgical, Orthopodic, and Restorative Devices
510(k) Number K091258
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
