The Trident® Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.
Device Story
Trident® "T" Acetabular Shells are orthopedic implants for cementless fixation in the acetabulum. Designed as hemispherical shells with thicker walls compared to predicate designs, allowing compatibility with smaller polyethylene bearing inserts. Features dome screw holes for optional 5.5mm or 6.5mm bone screws; screw holes shifted up to 4 degrees to maintain structural integrity on the inner radius. Used by orthopedic surgeons during total hip arthroplasty. The device provides a stable foundation for the hip joint, potentially improving patient mobility and reducing pain associated with degenerative joint disease. Thicker wall design provides mechanical stability comparable to or better than predicate shells, as confirmed by deflection testing.
Clinical Evidence
Bench testing only. Study compared deflection of subject devices against predicate shell designs upon implantation into the acetabulum. Results demonstrated that the thicker wall design of the subject devices exhibited less deflection than some predicate shells and approximately the same deflection as others.
Technological Characteristics
Hemispherical acetabular shell; cementless fixation; metal construction (same as predicates); features thicker walls than predicate designs; compatible with Trident® polyethylene bearing inserts; includes optional dome screw holes for 5.5mm or 5.5mm bone screws; screw hole positions shifted ≤4 degrees.
Indications for Use
Indicated for patients with painful, disabling hip joint disease (degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, late-stage avascular necrosis); revision of unsuccessful femoral head replacement, cup arthroplasty, or other procedures; clinical management where arthrodesis or alternative techniques are less likely to achieve satisfactory results; or cases where bone stock is of poor quality or inadequate for other reconstructive techniques due to acetabular deficiencies.
Regulatory Classification
Identification
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
Osteonics Secur-Fit-AD Generation II Acetabular Components (K983502)
Osteonics Generation II Acetabular Components (K983382)
Trident® AD and AD/HA Hemispherical Acetabular Shells (K013676)
Submission Summary (Full Text)
{0}------------------------------------------------
Trident" "T" Acctabular Shells
# MAY 2 5 2004
510(k) Premarket Notification
510(k) Summary of Safetv and Effectiveness for the TRIDENT® "T" SHELLS
K040412
page 1 of 3
Proprietary Name:
Common Name:
Classification Name and Reference
Regulatory Class:
Device Product Code:
For Information contact:
Date Summary Prepared:
February 17. 2004
## Identification of Predicates
- 1. K010170 Trident® Porous Titanium
- 2. K013475 Trident® Porous Titanium
K040412
page 1 of 3
Trident® "T" Acetabular Shells
Artificial Hip Components
Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR §888.3358
Class II
87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate,
87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Ginny Stamberger Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: (201) 831-5467 Fax: (201) 831-6038 E-Mail: Ginny.Stamberger@stryker.com
February 17. 2004
{1}------------------------------------------------
K040412
510(k) Premarket Notification
page 2 of 3
- 3. K983502 Osteonics Secur-Fit-AD Generation II Acetabular Components
- 4. K983382 formerly designated as Osteonics Generation II Acetabular Components
- 5. K013676 Trident® AD and AD/HA Hemispherical Acetabular Shells
## Device Description
The subject devices are identical to their corresponding predicate devices, except that they feature thicker walls. Consequently, for each shell size (except the smallest, which remains unchanged) the subject Trident® "T" Shells will be compatible with a liner one size smaller than ihat used for the predicate Trident® designs. In addition, to accommodate the thicker walls, the screw holes were mimimally shifted (not more than 4 degrees measured off the center of the shell) so as not to run into each other on the inner radius of the shell.
## Intended Use:
The Trident® "I" Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polyethylene acetabular bearing inserts. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.
## Indications
- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-oraunatic arthrits or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative rechniques are less likely to ache ve satisfactory results.
- · Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum
# Substantial Equivalence:
## Intended Use
The subject Trident® "T" Shells retain the same intended uses and same indications for use as the cited predicate Trident® Acetabular Shells.
## Materials
The subject Trident® "T" Shells are manufactured from the same materials as their corresponding predicate Trident Acetabular Shells.
## Design
The subject Trident® "T" Shells retain the same designs as their corresponding predicate Trident@ Acetabular Shells with the following exceptions: The subject devices (except for the smallest size, which was unmodified) feature thicker walls. As a consequence of the thicker
{2}------------------------------------------------
Trident® "T" Acetabular Shells
4/04/2
510(k) Premarket Notification
page 3 of 3
5
walls, each shell now accepts an insert that is one size smaller than what is used in the corresponding predicate Trident® System Shells. To accommodate the added thickness, the screw hole locations were shifted minimally so as not to run into each other on the inner radius of the shell. No single shift was more than 4 degrees measured off the center of the shell. These design modifications do not raise new questions of safety or effectiveness.
# Testing
A study was performed to compare the deflection experienced by the subject and predicate devices. The study demonstrated that the thicker wall design of the subject and presired.
Incode for the study demonstrated that thicker wall design of the subject devices re less deflection (upon implantation into the acetabulum) than in some predicate shellis in 1) in 1 2) about the same deflection as seen in other predicate shell designs.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Ms. Ginny Stamberger Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432
Re: K040412 Trade/Device Name: Trident® "T" Acetabular Shells Regulation Number: 21 CFR 888.3358, 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: LPH, LZO, MEH Dated: April 27, 2004 Received: April 28, 2004
Dear Ms. Stamberger:
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 such 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); 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.
{4}------------------------------------------------
Page 2 - Ms. Ginny Stamberger
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicated 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Mulkerson
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K0404/0
Device Name: Trident® "T" Acetabular Shells
Indications For Use:
The Trident® Acelabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polycthylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopacdics 6.5mm or 5.5mm bone screws.
Indications
- Painful, disabling joint disease of the bip resulting from: degenerative arthrins, theumatoid arthritis, post-traumatic . arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. .
- Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpari C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
l Mark N. Mulhearn
of General, Restorative, and Neurological Devices
Page 1 of
**510(k) Number** K040412
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.
