This device is intended for cemented use in the treatment of the following: Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis. Omarthrosis. Rheumatoid arthritis. Revision of shoulder prosthesis. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
Device Story
The Anatomical Shoulder System Keeled Glenoid is a shoulder prosthesis component designed for cemented fixation. It serves as a bone anchorage option within the existing Anatomical Shoulder System, maintaining established articular surface geometry. The device is intended for use by orthopedic surgeons in clinical settings to treat shoulder joint pathology, including arthritis and revision cases. By providing a keeled fixation interface, the device facilitates stable prosthetic implantation, aiming to restore shoulder joint function and alleviate pain for patients suffering from degenerative or traumatic joint conditions.
Clinical Evidence
No clinical data was required or provided for this device; substantial equivalence was established through non-clinical design assurance and performance testing.
Technological Characteristics
Shoulder joint metal/polymer semi-constrained cemented prosthesis. Keeled glenoid design. Materials, manufacturing, and sterilization processes are identical to the predicate device. Standalone orthopedic implant.
Indications for Use
Indicated for patients requiring shoulder joint replacement due to degenerative, posttraumatic, or rheumatoid arthritis, omarthrosis, or revision of a previous shoulder prosthesis. Includes traumatology applications using the specified traumatology cone.
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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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside, followed by the word "zimmer" in a bold, sans-serif font. A horizontal line is present below the word "zimmer".
+1
#### K 051623 1 •
# Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Brandon Hipsher<br>Specialist, Corporate Regulatory Affairs<br>Telephone: (574) 371-8083<br>Fax: (574) 372-4605 | |
| Date: | June 16, 2005 | |
| Trade Name: | Anatomical Shoulder™ System Keeled Glenoid | |
| Common Name: | Shoulder Prosthesis | |
| Classification Name<br>and Reference: | Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis<br>21 CFR § 888.3660 | |
| Predicate Device: | Anatomica All-Polyethylene Glenoid Component,<br>manufactured by Zimmer GmbH, K990136, cleared<br>March 1, 1999 | |
| Device Description: | The keeled glenoid component is part of the<br>Anatomical Shoulder System. It provides surgeons<br>with another bone anchorage option while<br>maintaining the system's articular surface geometry. | |
| Intended Use: | This device is intended for cemented use in the<br>treatment of the following:<br>Advanced wear and tear of the shoulder<br>joint resulting from degenerative,<br>posttraumatic or rheumatoid arthritis.<br>Omarthrosis.<br>Rheumatoid arthritis.<br>Revision of shoulder prosthesis.<br>Traumatology: the only cone to be used in<br>traumatological indications is the<br>traumatology cone. | |
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Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a large, bold letter 'Z' enclosed in a circle, followed by the word 'zimmer' in a smaller, bold font. The 'Z' in the circle is the most prominent element, with the word 'zimmer' positioned to its right.
| | ﻟﻤﺤﺎﻓﻈﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ |
|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Comparison to Predicate Device:
Except for a minor modification, the Anatomical Shoulder Keeled Glenoid is identical to the predicate device. This modification does not change the intended use or the fundamental scientific technology. The device is manufactured, packaged and sterilized using the same materials and processes.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this 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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.
JUL 19 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brandon Hipsher Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K051623
K051623
Trade/Device Name: Anatomical Shoulder™ System Keeled Glenoid Regulation Number: 21 CFR 888.3660 Kegulation Name: 21 CFR 866.5000
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: June 16, 2005 Received: June 20, 2005
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is a marketed in interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstant for use stated in the encrosule) to regary mancess producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 20, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosment Act (Act) that do not require approvial controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of Y ou may, merefore, market the dovres, seejest to annual registration, listing of
general controls provisions of the Act include requirements for annual registerading and general controls provisions of the fist 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 classified (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation ED may be subject to such additional controls. Extrong mayor one of on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a be found in the Code of Peach Regar
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 Please be advised that FDA s issualled of a budeum and other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decernmanon and Jour and Jour Federal agencies. You must in provision and ligit of any Federal statutes and regulations and interest by the not limited to: registration and issues and comply with an the Act 3 requirements, news manufacturing practice requirements as set CFK Part 807), idoeiing (21 CFR Part 801), good and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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### Page 2 - Mr. Brandon Hipsher
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will be of substantial equivalence of your device of your device to a legally prematicated predicated on "The 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 11 you a some of Compliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Companise market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronal 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,
signature
Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K051623 (1)
## Indications for Use
## 510(k) Number (if known):
Device Name:
. . . .
Anatomical Shoulder™ System Keeled Glenoid
#### Indications for Use:
This device is intended for cemented use in treatment of the following:
- · Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- · Omarthrosis.
- Rheumatoid arthritis.
- · Revision of shoulder prosthesis.
- · Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Eun.th
Cision Sign-Off) on of General, Restorative
Page 1 of 1
K051623
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.
