The Versa-Dial™ Humeral Head Prosthesis is intended for: 1) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. Rheumatoid arthritis. 2) Revision where other devices or treatments have failed. 3) 4) Correction of functional deformity. 5) Fractures of the proximal humerus where other methods of treatment are deemed inadequate. Difficult clinical management problems, including cuff tear arthropathy, where other methods of treatment may not be suitable or may be inadequate. Humeral components with a MacroBond® surface coating are indicated for either cemented or uncemented press-fit applications. Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.) Polyethylene glenoid components not attached to a metal back are indicated for cemented application only. The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive® Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular® Shoulder Stems, and the glenoid components of the Bio-Modular® Shoulder System. The device is a single use implant.
Device Story
Modular humeral head prosthesis system; provides variable offset (0.5mm to 4.5mm) to restore joint biomechanics. Consists of modular head and taper adaptor; adaptor impacted into head to set desired offset. Used in shoulder arthroplasty; implanted by orthopedic surgeons in clinical/hospital settings. Compatible with Comprehensive® and Bio-Modular® shoulder stems. Single-use implant; provides structural replacement for damaged humeral head; facilitates joint function restoration. Redesigned taper adaptor utilizes Ti-6Al-4V alloy.
Clinical Evidence
No clinical data provided. Substantial equivalence based on non-clinical laboratory testing.
Technological Characteristics
Modular humeral head prosthesis; materials include Ti-6Al-4V for taper adaptor. Features MacroBond® surface coating for press-fit or porous coating for biological fixation. Variable offset range 0.5mm to 4.5mm. Single-use implant.
Indications for Use
Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal humerus fractures, or cuff tear arthropathy requiring revision or where other treatments are inadequate. For use with specific Biomet shoulder stems and glenoid components.
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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JUN 1 2 2006
# 510(k) Summarv
| Preparation Date: | June 8, 2006 |
|--------------------|-------------------------------------|
| Applicant/Sponsor: | Blomet Manufacturing Corp. |
| Contact Person: | Susan Alexander |
| Proprietary Name: | Versa-Dial™ Humeral Head Prosthesis |
| Common Name: | Shoulder Prosthesis |
## Classification Name:
- Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR §888.3650) .
- Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 5888.3660) .
- Shoulder joint metal/polymer/metal/non-constrained or semi-constrained porous-coated . uncemented prosthesis (21 CFR 6888,3670)
- . Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690)
### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- Versa-Dial™ Humeral Head Prosthesis; Blomet Manufacturing Corp. (K040610) .
- . Blo-Modular® Shoulder System; Blomet Orthopedics, Inc. (K030710)
- Absolute® Bl-Polar Shoulder System; Blomet Manufacturing Corp. (K002998) ●
Device Description: The Versa-Dial™ Humeral Head Prosthesis consists of a series of varioussized modular humeral heads with variable offset between 0.5mm and 4.5 mm. Each modular head consists of a head and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Blomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System depending upon which taper is used (i.e., in order to use with the Comprehensive® shoulder stem, the Comprehensive® Taper Adaptor must be used).
Intended Use: The Versa-Dial™ Humeral Head Prosthesis is intended for:
- 1) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2)
- Revision where other devices or treatments have falled. 3)
- 4) Correction of functional deformity.
- 5) Fractures of the proximal humerus where other methods of treatment are deemed Inadequate.
- Difficuit dinical management problems, Including cuff tear arthropathy, where other ର) methods of treatment may not be sultable or may be Inadequate.
Humeral components with a MacroBond® surface coating are indicated for either cemented or uncemented press-fit applications.
| 5-1 | | |
|---------------------------------------|--------------------------------------|-------------------|
| MAILING ADDRESS | SHIPPING ADDRESS | |
| P.O. Box 587<br>Warsaw, IN 46581 0587 | 56 E. Bell Drive<br>Warsaw, IN 46582 | |
| OFFICE | FAX | E-MAIL |
| 574.267.6639 | 574.267.8187 | biomet@biomet.com |
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### Page 2 of 2 510(k) Summary; Versa-Dlal™ Humeral Head Prosthesis Blomet Manufacturing Corp.
Hymeral/glenoid components with a porous coated surface coating are Indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.)
Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.
The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive® Shoulder Stems (Fracture, Primary and Revision), the Blo-Modular® Shoulder Stems, and the glenoid components of the Bio-Modular® Shoulder System.
The device is a single use implant.
Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the Versa-Dial™ Humeral Head Prosthesis are similar or identical to the predicate devices. The device has been redesigned since it was deared in K040610. The redesigned Versa-Dial™ taper adaptor is comprised of TT-6AI-4V; the predicate Versa-Dial™ taper adaptor is made of Co-Cr-Mo. The Indicla on the underside of the new device have changed from numbers to letters.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results Indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Unless otherwise noted, all trademarks are property of Blomet.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2006
Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K060716 Trade/Device Name: Versa-Dial™ Humeral Head Prosthesis Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWS, HSD Dated: March 16, 2006 Received: March 17, 2006
Dear Ms. Alexander:
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.
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Page 2 – Ms. Susan Alexander
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 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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Semmler
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K060716
# Indications for Use
510(k) Number (if known):_
Device Name: Versa-Dial™ Humeral Head Prosthesis
Indications For Use:
The Versa-Dial™ Humeral Head Prosthesis Is intended for:
- 1) Non-Inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- 2) Rheumatoid arthritis.
- 3) Revision where other devices or treatments have failed.
- 4) Correction of functional deformity.
- 4) Corrector of the proximal humerus where other methods of treatment are deemed Inadequate.
- indequate: methods of treatment may not be suitable or may be inadequate.
Humeral components with a MacroBond® surface coating are indicated for either cemented or uncemented press-fit applications.
Humeral/glenoid components with a porous coated surface coating are Indicated for either cemented or uncemented blological fixation applications. (Metal backed glenoid components offer optional screw fixation.)
Polyethylene glenold components not attached to a metal back are indicated for cemented application only.
The Versa-Dial™ Humeral Head Prosthesis is Intended for use only with the Comprehensive® Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular® Shoulder Stems, and the glenold components of the Blo-Modular® Shoulder System.
The device is a single-use implant.
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
4-1
Hubert Lemmer
Division Sign-Of Division of General, Restorage of 1 and Neurological Devices
1060716 510(k) Number_
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.
