The Global Fx Porous-coated humeral stem, in combination with Global shoulder humeral heads, is intended for use in total or hemi-arthroplasty.
Device Story
Global Fx Porous-Coated Humeral Stem is a shoulder prosthesis component for total or hemi-arthroplasty. Device consists of a cobalt-chromium-molybdenum alloy stem with a proximal Porocoat® porous coating to facilitate biological tissue in-growth for cementless fixation; also compatible with cemented use. Stem mates with previously cleared Global Advantage humeral heads. Used by orthopedic surgeons in clinical settings for patients with severe joint pain, arthritis, fractures, or necrosis. Device provides structural replacement of the humeral head, restoring joint function and reducing pain. No software or algorithmic components.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Cobalt-chromium-molybdenum alloy (ASTM F-75). Porous-coated proximal stem for biological tissue in-growth. Tapered design with locking taper interface for humeral head attachment. Intended for cemented or cementless use. No software or electronic components.
Indications for Use
Indicated for patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, or rheumatoid arthritis; proximal humerus fracture-dislocations with severe comminution or compromised blood supply; difficult clinical problems where arthrodesis/resection arthroplasty are unacceptable (e.g., revision); and rotator cuff tear arthropathy. Hemi-shoulder replacement also indicated for ununited humeral head fractures and avascular necrosis. Porous-coated components indicated for cementless use (biological tissue in-growth); components labeled 'For cemented use only' indicated for use with bone cement.
Regulatory Classification
Identification
A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. 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. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
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JUL - 6 2001
K011099
# 510(k) Summary
| Name of Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Marcia J. Arentz<br>Senior Regulatory Associate<br>Phone: (219) 371-4944<br>FAX: (219) 371-4987 |
| Trade Name: | Global™ Fx Porous-Coated Humeral Stem |
| Common Name: | Shoulder prosthesis, humeral head |
| Classification: | Class II (special controls) per 21 CFR 888.3670<br>Shoulder joint metal/polymer/metal non-constrained or<br>semi-constrained porous-coated uncemented prosthesis. |
| | Class II (special controls) per 21 CFR 888.3660<br>Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis. |
| Device Product Code: | Code: 87 MBF Prosthesis, Shoulder, semi-constrained, metal/polymer, Uncemented.<br>Code: 87 KWS Prosthesis, Shoulder, Semi-con-strained, metal/polymer Cemented. |
| Substantially Equivalent Devices: | Global Fx Shoulder System<br>K984541<br>Porous Coated Global Shoulder<br>K943300 |
| Device Description: | The Porous-coated Global Fx humeral stem is a<br>modified Global Fx humeral stem. Porocoat® porous<br>coating has been added to the proximal portion of the<br>stem. The stem is manufactured from cobalt-<br>chromium --molybdenum alloy conforming to ASTM<br>F-75. The stem mates with humeral heads previously<br>cleared as Global Advantage Head (K984541),<br>Global Advantage CTA Heads (K000575) and the<br>Global Advantage Eccentric Humeral Head<br>(K992065). |
| Intended use: | The Global Fx Porous-coated humeral stem, in<br>combination with Global shoulder humeral heads, is<br>intended for use in total or hemi-arthroplasty. |
| Indications for use: | Total or hemi-shoulder replacement is indicated for: |
| | 1. A severely painful and/or disabled joint resulting<br>from osteoarthritis, traumatic arthritis or rheumatoid<br>arthritis; |
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Fracture-dislocations of the proximal humerus. 2. where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
Other difficult clinical problems where shoulder 3. or resection arthroplasty are not arthrodesis acceptable (e.g., revision of a failed primary component).
Rotator cuff tear arthropathy. 4.
Hemi-shoulder replacement is also indicated for:
- 1. Ununited humeral head fractures;
Avascular necrosis of the humeral head. 2.
The Global Fx porous-coated humeral stem is intended for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating.
### Substantial equivalence:
The Global Advantage Extended Humeral Head is substantially equivalent to the Global Fx Humeral Stem cleared in K984541. Both humeral stems have identical locking tapers, are tapered in design, come in similar sizes and are manufactured from the same materials. The only difference between the two stems is the addition of porous coating to the proximal portion of the stem.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human face in profile, with three curved lines representing the hair or head.
JUL - 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K011099
Trade Name: Global™ Fx Porous-Coated Humeral Stem Regulation Number: 888.3670 and 888.3660 Regulatory Class: II Product Code: MBF and KWS Dated: April 10, 2001 Received: April 11, 2001
Dear Ms. Arentz:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use above and we nave actering in interstate commerce prior to May 28, 1976, the stated in the oneroune) to were amendments, or to devices that have been reclassified in oncentions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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, cond 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 regulations ( remainer ripple any 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
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
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Page 2 - Ms. Marcia J. Arentz
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 If you desire specific advice for your do rices), please contact the Office of Compliance at additionally 809.10 for in This diagnotions on the promotion and advertising of your device, (301) 394-4639. Addinonally, for questions on (301) 594-4639. Also, please note the regulation please comact the Orifice or Compilance at (2017) of the Station" (21 CFR 807.97). Other general entitled, TMIsoraliumly by releveles to pearler to act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from 11, miorination on your responsionates and in more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
thlulln
S.M. White, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# 510(k) Number (if known): Κοι/ο 99
## Device Name: Global™ Fx Porous-Coated Humeral Stem
## Indications for Use:
Total or hemi-shoulder replacement is indicated for:
- 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
- 2. Fracture-dislocations of the proximal humerus where the articular surface is severely Fracture chooseneed from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
- 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
- 4. Rotator cuff tear arthropathy.
Hemi-shoulder replacement is also indicated for:
- 1. Ununited humeral head fractures;
- 2. Avascular necrosis of the humeral head.
### Porocoat® Porous-Coated Components
I orocoal " orous-coated humeral stem prostheses are indicated for cementless use with fixation provided by biological tissue in-growth into the porous coating.
### Cemented Components
Humeral stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Pcr 21 CFR/801.109)
OR
Over-The-Counter Use
No
comiraveto orcm
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011097
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.
