The DELTA XTEND Reverse Shoulder prosthesis is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement.
Device Story
The DELTA XTEND Reverse Shoulder System is a modular shoulder prosthesis used in total or hemi-shoulder arthroplasty. It replaces the shoulder joint in patients with non-functional rotator cuffs. The system consists of humeral components (modular stem and epiphysis) and glenoid components (metaglene). The metaglene is hydroxyapatite (HA) coated for cementless fixation using screws; humeral components are also HA coated for cementless use. Other metallic components are intended for cemented use. The device is implanted by orthopedic surgeons in a clinical/surgical setting. It restores joint function and stability, benefiting patients with severe arthropathy, failed prior replacements, or complex fractures. This submission specifically addresses an additional manufacturing and sterilization site and updated packaging for the HA-coated components.
Clinical Evidence
No clinical tests were conducted. Substantial equivalence is supported by non-clinical bench testing, including biological safety, packaging validation, sterilization validation, and characterization of the hydroxyapatite coating per FDA guidance.
Technological Characteristics
Modular shoulder prosthesis. Materials: Titanium alloy with hydroxyapatite (HA) coating. Components: Modular humeral stem, modular epiphysis, metaglene. Fixation: Cementless (HA-coated components with screws) and cemented (other metallic components). Sterilization: Validated per AAMI ANSI ISO 11137-1/2.
Indications for Use
Indicated for treatment of grossly deficient rotator cuff joint with severe arthropathy, failed joint replacement, or proximal humerus fracture-dislocations where articular surface is comminuted/avascular or alternative treatments are unsatisfactory. Requires anatomically suited joint and functional deltoid muscle. Hemi-shoulder replacement indicated for hemi-arthroplasty if glenoid is fractured intraoperatively or for revision of failed DELTA XTEND Reverse Shoulder.
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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October 04, 2019
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DePuy(Ireland) % Ashley Goncalo Project Manager-Regulatory Affairs DePuy Orthopaedies, Inc. 700 Orthopaedies Dr. Warsaw, Indiana 46582
Re: K192448
Trade/Device Name: DELTA XTEND™ Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD Dated: September 4, 2019 Received: September 6, 2019
Dear Ashley Goncalo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael C. Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
### K192448
Device Name DELTA XTEND Reverse Shoulder System
Indications for Use (Describe)
The DELTA XTEND Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or:
· a previously failed joint replacement and/or:
· fracture-dislocations of the proximal humerus 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.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> </span> </span> <span style="font-family: Symbol;"> <span style="font-size: 10pt;"> </span> </span> <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> | Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary
As required by 21 CFR 807.92 and 21 CFR 807.93
| Submission Information | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor Name | DePuy (Ireland) |
| Sponsor Address | Loughbeg, Ringaskiddy Co. Cork Ireland |
| Sponsor Establishment<br>Registration Number | 9616671 |
| 510(k) Contact | Ashley Goncalo<br>DePuy Synthes<br>Regulatory Project Manager<br> |
| Date prepared | September 4, 2019 |
| Device Information | |
| Trade or proprietary name | DELTA XTEND™ Reverse Shoulder System |
| Common or usual name | Shoulder Prosthesis |
| Classification name | Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis |
| Class, regulation | Class II, 21 CFR 888.3660 |
| Product Code | PHX, HSD |
| Classification panel | Orthopedics panel |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | DELTA XTEND Reverse Shoulder System (DePuy: K062250,<br>K071379, K120174) |
| Reason for 510(k)<br>submission | Introduction of an additional manufacturing and sterilization site<br>for the hydroxyapatite (HA) coated system components that are<br>marketed as part of the DELTA XTEND Reverse Shoulder<br>System. Additionally, there is an update to packaging<br>configuration for these system components. |
| Device description | The DELTA XTEND Reverse Shoulder System is currently<br>cleared and marketed by DePuy Synthes and is comprised of<br>multiple humeral and glenoid implant components. These are<br>provided as separate, standalone devices and may be used in<br>conjunction to form a total shoulder prothesis. This submission is<br>pertinent to only those system components which are HA coated:<br>Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes |
| Intended use of the device | The DELTA XTEND Reverse Shoulder prosthesis is intended for<br>use in total or hemi-shoulder arthroplasty procedures in patients<br>with non-functional rotator cuffs, with or without bone cement. |
| Indications for use | The DELTA XTEND Shoulder Prosthesis is indicated for use in<br>treatment of a grossly deficient rotator cuff joint with:<br>• severe arthropathy and/or;<br>• a previously failed joint replacement and/or:<br>• fracture-dislocations of the proximal humerus where the<br>articular surface is severely comminuted, separated from its<br>blood supply or where the surgeon's experience indicates<br>that alternative methods of treatment are unsatisfactory<br>The patient's joint must be anatomically and structurally suited to<br>receive the selected implant(s), and a functional deltoid muscle is<br>necessary to use the device.<br>DELTA XTEND hemi-shoulder replacement is also indicated for<br>hemi-arthroplasty if the glenoid is fractured intraoperatively or for<br>the revision of a previously failed DELTA XTEND Reverse<br>Shoulder.<br>The metaglene component is HA coated and is intended for<br>cementless use with the addition of screws for fixation.<br>The modular humeral stem and humeral epiphysis components are<br>HA coated and intended for cementless use. All other metallic<br>components are intended for cemented use only. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT<br>DEVICE COMPARED TO THE PREDICATE DEVICE | | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Subject Device:<br>DePuy Synthes DELTA<br>XTEND™ Reverse Shoulder<br>System | Predicate Device:<br>DePuy Synthes DELTA<br>XTEND™ Reverse Shoulder<br>System (K062250, K071379,<br>K120174) |
| Intended Use | Reverse shoulder arthroplasty | Reverse shoulder arthroplasty |
| Material | | |
| Humeral Implants<br>(Modular<br>Humeral Stem,<br>Modular<br>Epiphysis) | Titanium alloy with HA coating | Titanium alloy with HA coating |
| Glenoid Implants<br>(Metaglene) | | |
| Design | | |
| Humeral Implants<br>(Modular<br>Humeral Stem,<br>Modular<br>Epiphysis) | Modular, without cement,<br>composed of an epiphysis and a<br>humeral stem made out of titanium<br>and coated with hydroxyapatite.<br>The epiphysis is available in<br>standard or long version and in two<br>sizes in order to be able to adapt as<br>well as possible to the human<br>anatomy. The distal stem is<br>available in several diameters to<br>maximize the adaptability of<br>humeral canal. | Modular, without cement,<br>composed of an epiphysis and a<br>humeral stem made out of titanium<br>and coated with hydroxyapatite.<br>The epiphysis is available in<br>standard or long version and in two<br>sizes in order to be able to adapt as<br>well as possible to the human<br>anatomy. The distal stem is<br>available in several diameters to<br>maximize the adaptability of<br>humeral canal. |
| Glenoid Implant<br>(Metaglene) | The Glenoid Implant is comprised<br>of a glenosphere that is fixed on the<br>metaglene by a conical joint and a<br>central pin.<br><br>The metaglene is coated with<br>hydroxyapatite and is fixed inside<br>the bone with 4 screws. This<br>submission pertains to the metaglene<br>component of the Glenoid Implant<br>only. | The Glenoid Implant is comprised<br>of a glenosphere that is fixed on the<br>metaglene by a conical joint and a<br>central pin.<br><br>The metaglene is coated with<br>hydroxyapatite and is fixed inside<br>the bone with 4 screws |
| PERFORMANCE DATA | | |
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## SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the DELTA XTEND Reverse Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Biological safety per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: ● Evaluation and Testing".
- Packaging validation per ISO 11607-1 and ISO 11607-2 utilizing ISTA 3A. ●
- Sterilization validation per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ● ISO 11137-2: 2013
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- Characterization testing of Hydroxyapatite Coating as recommended per FDA ● Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"
# SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The HA coated Modular Humeral Stem, Modular Epiphysis, and Metaglene of the DELTA XTEND Reverse Shoulder System is substantially equivalent to the HA coated Modular Humeral Stem, Modular Epiphysis, and Metaglene of the predicate DePuy Synthes DELTA XTEND Reverse Shoulder System (K062250, K071379, K120174).
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.
