K050315 · DePuy Orthopaedics, Inc. · PHX · May 16, 2005 · Orthopedic
Device Facts
Record ID
K050315
Device Name
DELTA HUMERAL CUPS
Applicant
DePuy Orthopaedics, Inc.
Product Code
PHX · Orthopedic
Decision Date
May 16, 2005
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3660
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Delta CTA™ Humeral Cups, as part of the DePuy Delta CTA™ Total Shoulder are intended for use in patients with non-functional rotator cuffs with or without bone cement. The Delta CTA™ Total Shoulder Prosthesis is indicated for use in grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device. The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
Device Story
Delta CTA™ Humeral Cups are polyethylene prosthetic components for total shoulder replacement. They function as part of the Delta CTA™ system to restore joint function in patients with non-functional rotator cuffs. The device is implanted by an orthopedic surgeon in a clinical/surgical setting. The cups are available in various diameters (36mm, 42mm) and thicknesses (+3mm, +9mm) to accommodate patient anatomy. The device replaces damaged joint surfaces, aiming to improve mobility and reduce pain in patients with severe arthropathy or failed previous replacements. It is a mechanical implant; no software or electronic processing is involved.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Polyethylene humeral cups; available in 36mm and 42mm diameters with +3mm and +9mm thicknesses. Designed for use with the Delta CTA™ Total Shoulder system. Mechanical implant; no energy source or software.
Indications for Use
Indicated for patients with grossly rotator cuff deficient joints, severe arthropathy, or failed prior joint replacement. Requires anatomically/structurally suitable joint and functional Deltoid muscle.
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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K050315
MAY 1 6 2005
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#### 510(k) Summary
NAME OF SPONSOR:
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910
MANUFACTURER:
DePuy France S.A. ZILa Vendue BP88 Chaumont 52003 France Est. Reg. No. 9615674
510(K) CONTACT:
Natalie S. Heck Manager, Regulatory Affairs Phone: (574) 372-7469 FAX: (574) 371-4987
Delta CTA™ Humeral Cups
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
Shoulder Prosthesis
Class II Device per 21 CFR 888.3660: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
DEVICE PRODUCT CODE:
87 KWS
SUBSTANTIALLY EQUIVALENT DEVICES:
DePuy Delta Shoulder, K021478
## DEVICE DESCRIPTION:
The Delta CTA™ Humeral Cups proposed in this submission are a line extension to the humeral cup system components cleared in the DePuy Delta CTA™ Shoulder submission (cleared as DePuy Delta Shoulder under K021478, November 18, 2003). The additional humeral cups are made of polyethylene and will be available in four sizes: 36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness.
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# 510(k) Summary (cont.)
## INTENDED USE AND INDICATIONS:
The Delta CTA™ Humeral Cups, as part of the DePuy Delta CTA™ Total Shoulder are intended for use in patients with non-functional rotator cuffs with or without bone cement.
The Delta CTA™ Total Shoulder Prosthesis is indicated for use in grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
### BASIS OF SUBSTANTIAL EQUIVALENCE:
DePuy believes the humeral cups proposed in this submission are substantially equivalent to the humeral cups cleared in the previous DePuy Delta CTA™ Total Shoulder Prosthesis submission. The design, material and manufacturing method of the humeral cups is identical to those cleared in K021478 (cleared November 18, 2003), however the range of sizes of available cups will be increased to 36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness. Currently, humeral cups compatible with the Delta CTA™ Total Shoulder prosthesis are available in 36mm diameters in +0mm and + 6mm thicknesses, and 42mm diameters in +0mm and + 6mm thicknesses.
2.12
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2005
Ms. Tiffani D. Rogers DePuy Orthopaedics Incorporated P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K050315
Trade/Device Name: Delta CTA™ Humeral Cups Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: April 15, 2005 Received: April 20, 2005
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asc stated in the encreate) to 10gains the Medical Device Amendments, or to commerce provision to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic 7.0. (71ct) that to nevies, subject to the general controls provisions of the Act. The 1 ou may, therefore, maines of the Act include requirements for annual registration, listing of general Controls provisions of the 110 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 your device is elassified (660 ace v) in 1. Existing major regulations affecting your device It inay be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Ood or ements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean F Icase oc advised that I Dri 3 issualles of our device complies with other requirements of the Act that IDA has made a actorinments in administered by other Federal agencies. You must of any I cuchares and regaranents, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, n.e., and 801); good manufacturing practice requirements as set Crith in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 fordin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Tiffani D. Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manieting of substantial equivalence of your device to a legally premarket notification: "The PDT intacle sification 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 10. J at (240) 276-0120 . Also, please note the regulation entitled, Comace the Office of Compilance in (21CFR Part 807.97). You may obtain Missuranting Uy Terefone to premainsmonibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stypt Rhode
Na. Virginia C.B., D.st, Ph.D.
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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Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Delta CTA™ Humeral Cups
Indications for Use:
A Delta Total shoulder prosthesis is indicated for use in:
Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is neoessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
X Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ﻴﺔ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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**510(k) Number** K050315
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.
