INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
K983942 · Smith & Nephew, Inc. · JDS · Dec 4, 1998 · Orthopedic
Device Facts
Record ID
K983942
Device Name
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
Applicant
Smith & Nephew, Inc.
Product Code
JDS · Orthopedic
Decision Date
Dec 4, 1998
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 888.3030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants. Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocal，aneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint. Knee Fusion Nails are intended for intramedullary knee arthrodesis. Ender Nails are indicated as follows: fracture of the neck, trochanteric, and subtrochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.
Device Story
Intramedullary Nail System comprises femoral, tibial, ulnaradial, humeral, ankle fusion, and knee fusion nails; accessories included. Used for internal fixation of long bone fractures and arthrodesis. Surgical implantation performed by orthopedic surgeons in clinical/OR settings. Provides mechanical stabilization of bone segments to facilitate healing. Components manufactured from stainless steel and UHMWPE.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and technological characteristics compared to legally marketed predicate devices.
Technological Characteristics
Intramedullary fixation rods; materials include stainless steel and UHMWPE. Design features include interlocking holes/slots for screws to provide compression and rotational stability. System includes various nail geometries for femoral, tibial, ulnaradial, humeral, and fusion applications.
Indications for Use
Indicated for patients with long bone fractures (simple, comminuted, spiral, segmental), nonunions, malunions, polytrauma, impending pathologic fractures, tumor resection, bone lengthening/shortening, and specific hindfoot/ankle/knee arthrodesis needs. Applicable to femoral, tibial, ulnaradial, humeral, and ankle/knee fusion applications.
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
Trimax Nail System
Reference Devices
Titanium Femoral/Recon Antegrade Nail (Smith & Nephew Orthopaedics)
Femoral Retrograde/Tibial Nail 1 (Smith & Nephew Orthopaedics)
TriMax Femoral/Recon Antegrade Nail (Smith & Nephew Orthopaedics)
1 piece Femoral Retrograde Nail 2 (Smith & Nephew Orthopaedics)
AIM Femoral, Supracondylar, Tibial Nails (DePuy Ace)
Titanium Unreamed Femoral Nail System (Synthes)
Kuntscher Nails (Smith & Nephew Orthopaedics)
Uniflex Tibial and Humeral Nail Systems (Biomet)
Grosse & Kempf Tibial Nail (Howmedica)
Alta Tibial/Humeral Modular Trauma System (Howmedica)
True/Flex IM Rod System (Applied Osteo Systems)
Small Bone Locking Nail (Biomet)
Polarus Humeral and AF Rods (Acumed)
Atlas Fracture Proximal Humeral Nail (Biomet)
Tibia-Talus-Calcaneus Nail (Smith & Nephew Orthopaedics)
Knee Fusion Nail (Smith & Nephew Orthopaedics)
Submission Summary (Full Text)
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## 510(k) Summary Intramedullary Nail System
Smith & Nephew, Inc
K98 3942
Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
1450 Brooks Road, Memphis, TN 38116 901/399-5861 JoAnn Kuhne November 4, 1998
Trade or proprietary device name: Common or unusual name: Classification name: Legally marketed predicate device:
Intramedullary Nail Intramedullary Nail Title 21 CFR 888.3020 - Intramedullary Fixation Rod Class II Trimax Nail System
## Subject device description:
The Intramedullary Nail System includes femoral, tibial, ulnaradial, humeral, ankle fusion, knee fusion nails and accessories. Components are manufactured from stainless steel and UHMWPE.
## Subject device intended use:
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures: prophylactic nailing of impending pathologic fractures: reconstruction, following tumor resection and grafting; supracondylar fractures; and bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement: ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; and fractures above total knee implants.
Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Ender Nails are indicated as follows: fracture of the neck, trochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.
{1}------------------------------------------------
## 510(k) Summary (cont.) Intramedullary Nail System
## Technological characteristics:
The Intramedullary Nail System is similar to the devices listed below.
- Titanium Femoral/Recon Antegrade Nail and the Femoral Retrograde/Tibial Nail 1. (Smith & Nephew Orthopaedics)
- TriMax Femoral/Recon Antegrade Nail and the 1 piece Femoral Retrograde Nail 2. (Smith & Nephew Orthopaedics)
- 3. AIM Femoral, Supracondylar, Tibial Nails (DePuy Ace)
- Titanium Unreamed Femoral Nail System (Synthes) 4.
- Kuntscher Nails for the femur, tibia, ulna/radius, and humerus 5. (Smith & Nephew Orthopaedics)
- Uniflex Tibial and Humeral Nail Systems (Biomet) 6.
- 7. Grosse & Kempf Tibial Nail (Howmedica)
- Alta Tibial/Humeral Modular Trauma System (Howmedica) 8.
- True/Flex IM Rod System for the Humerus, Ulna and Radius (Applied Osteo Systems) 9.
- 10. Small Bone Locking Nail (Biomet)
- 11. Polarus Humeral and AF Rods (Acumed)
- 12. Atlas Fracture Proximal Humeral Nail (Biomet)
- 13. Tibia-Talus-Calcaneus Nail (Smith & Nephew Orthopaedics)
- 14. Knee Fusion Nail (Smith & Nephew Orthopaedics)
All of the devices listed above are similar in design to the Intramedullary Nail System. The new devices have the same technological characteristics as the predicate device.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Ms. JoAnn M. Kuhne Manager, Regulatory Affairs Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re : K983942 Intramedullary Nail System Trade Name: Regulatory Class: II Product Code: JDS Dated: November 4, 1998 November 5, 1998 Received:
Dear Ms. Kuhne:
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 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 requlations 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 (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 regulations.
{3}------------------------------------------------
#### Page 2 - Ms. JoAnn M. Kuhne
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 (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
Enclosure
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# Abbreviated Premarket Notification Indications Statement Intramedullary Nail System Smith & Nephew Inc.
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.
Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Ender Nails are indicated as follows: fracture of the neck, trochanteric, and subtrochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.
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Prescription Use (Per 21 CFR 801.109)
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.
