Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable. The AEQUALIS Shoulder System is intended for cemented use only.
Device Story
AEQUALIS Shoulder System is a modular, semi-constrained, cemented total or hemi-shoulder prosthesis. It replaces or restores glenohumeral joint function to reduce pain and disability. The system consists of humeral stems and glenoid components. This modification adds three long humeral stems to the existing product line. The device is implanted by orthopedic surgeons in a clinical/surgical setting. The surgeon selects components based on the patient's disease state or injury. The modular design allows for primary hemi-arthroplasty with the potential for future conversion to total shoulder replacement. The device provides a mechanical replacement for damaged joint structures, aiming to restore joint mechanics and alleviate pain.
Clinical Evidence
No clinical data provided. The submission relies on bench testing and design equivalence to previously cleared devices.
Technological Characteristics
Semi-constrained, cemented shoulder prosthesis. Materials: Titanium alloy (ISO 5832-3) or Chromium-Cobalt alloy (ISO 5832-4). Modular design including humeral stems and glenoid components. Intended for cemented fixation.
Indications for Use
Indicated for patients with severe pain or disability due to degenerative, rheumatoid, or traumatic glenohumeral joint disease, non-union humeral head fractures, displaced 3- or 4-part proximal humeral fractures, or avascular necrosis of the humeral head. Intended for cemented use only.
Regulatory Classification
Identification
A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Special Controls
*Classification.* Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
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K041339
# Surgical In
# Summary of Safety and Effectiveness information Special 510(k) - AEQUALIS Shoulder System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name Trade name: Common name: Classification name:
AEQUALIS Shoulder System Total-Shoulder System and Hemi-Shoulder System Shoulder joint metal/polymer semi-constrained cemented prosthesis
## 2) Submitter
Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
### 3) Company contact
Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mircille.lemervatornier.fr
4) Classification Device class: Class II Classification panel: Orthopedic KWS Product code: \$ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
#### 5) Equivalent / Predicate device
AEQUALIS Shoulder system, TORNIER SA (K952928) Select Shoulder CoCr Humeral stem, Intermedics Orthopedics Inc, (K962315)
Image /page/0/Picture/14 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is bold and has a unique design, with the top part appearing to be a double "T" and the vertical line of the "T" extending to the bottom of the hexagon. The logo is black and white, with the "T" being black and the hexagon being white.
TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE
Phone : 33 (0)4 76 61 35 (0) Fax : 33 (0)4 76 61 35 33
S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B
REGISTERED OFFICE : B.P. 11 - cue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
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K041339
#### 6) Device description
0) Devel deseription conditions such as extensive soft tissue damage to the gleno-humeral joint, osteoarthritis, rheumatoid otheritis, traumatic arthritis, and osteonecrosis following severe trauma to the joint. The usual goal of such surgery is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The SEQUALIS Shoulder System is intended to accomplish these goals. With the AEQUALIS Shoulder System the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease of injury. Through the AEQUALIS Shoulder System is primarily intended for use as a cemented total shoulder replacement system, it is equally useful as a hemi-shoulder. The modular nature of this system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
The present Device Modification submission corresponds to the addition of 3 long humeral stems to 3 Inc pressite 2010 stem/neck angle, with the same indications for use already covered by the previous 510(k) clearance.
#### 7) Materials
7) The humeral implant is manufactured from titanium alloy (TA6V4) in accordance with ISO standard 5832-3 or in chromium-cobalt alloy (CrCo) according to ISO standard 5832-4, depending on models.
#### 8) Indications
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatio disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable. The AEQUALIS Shoulder System is intended for cemented use only.
Image /page/1/Picture/10 description: The image shows a logo with two stylized letters, 'T' and 'P', combined to form a single symbol. The 'T' is larger and forms the outer shape, while the 'P' is smaller and nestled within the 'T'. The entire symbol is enclosed within a hexagon, creating a clean and geometric design.
TORNIER S.A 161. rue Lavoisier 38330 MONTBONNOT FRANCE
Phone : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A. au capital de 1 800 (00 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B
Page 2/ page 2
REGISTERED OFFICE : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes representing the department's mission to promote health, well-being, and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Mrs. Mireille Lemery Regulatory Affairs & Quality Engineer TORNIER S.A. Zirst - 161, rue Lavoisier 38330 Montbonnot France
Re: K041339
Trade/Device Name: AEQUALIS Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: May 11, 2004 Received: May 20, 2004
Dear Mrs. Lemery:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosaly to tegains and the Medical Device Amendments, or to conniner of the 11th 11th 2011 de neces mat nave been recuire approval of a premarket approval application (PMA). and Costicule For (110) that as nov separal controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is oldssinod (600 above) and existing major regulations affecting your device can Inay be subject to subli additions, 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 i least be advised that I DTT 3785aanse over device complies with other requirements of the Act that I Dri has made a aved regulations administered by other Federal agencies. You must or any i cacial statutes and regations and and limited to: registration and listing (21 Comply with an the Not 810 crocations, 01); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quino) by the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your section 510(k) I his reter will anow you to begin maneting your as a read of your device to a legally premitsel notification. The PDA mining of casomation 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 If you desire specific advice for your de 1100 of Also, please note the regulation entitled, and Coniact the Office of Compuner an (est notification" (21CFR Part 807.97). You may obtain Misolallums by reference to premainters with the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milkersan
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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Special 510(k); Device modification - Premarket Notification 510(k) AEQUALIS Shoulder System
# Indications for Use
#### 510(k) Number (if known): K041339
Device Name: AEQUALIS Shoulder System
Indications For Use:
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
The AEQUALIS Shoulder System is intended for cemented use only.
Prescription Use ✓ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K041339
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.
