The WMT Modular Shoulder is indicated for use in shoulder arthroplasty for reduction or relief of pain and/or improved shoulder function in skeletally mature patients with sufficient and satisfactory bone stock to support the prosthesis with the following conditions: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis or post-traumatic arthritis; Revision where other devices or treatments have failed; Correction of functional deformity; Treatment of acute fracture of the humeral head unmanageable using other treatment methods; and Cuff tear arthroplasty. Hemi-shoulder replacement is also indicated for: Ununited humeral head fractures; and Avascular necrosis of the humeral head. The humeral stem may be implanted by press-fit or cement fixation.
Device Story
Modular shoulder prosthesis system comprising humeral stems, humeral heads, and glenoid implants. Designed for shoulder arthroplasty to address degenerative joint disease, fractures, and revision cases. Components allow for press-fit or cemented fixation of humeral stems. System provides multiple stem sizes and head radii/heights to accommodate patient anatomy. Used by orthopedic surgeons in clinical settings to restore joint function and reduce pain. Device functions as a mechanical replacement for the shoulder joint; no electronic or software components involved.
Clinical Evidence
Bench testing only.
Technological Characteristics
Modular shoulder prosthesis system. Components: humeral stem, humeral head, glenoid implants. Materials: metal/polymer. Fixation: press-fit or cemented. Humeral stems available in various lengths (110mm-225mm) and diameters (6mm-16mm). Humeral heads available in 5 radii (20-28mm) and 3 heights. Mechanical device; no energy source, connectivity, or software.
Indications for Use
Indicated for skeletally mature patients requiring shoulder arthroplasty for pain relief or improved function due to osteoarthritis, avascular necrosis, rheumatoid arthritis, post-traumatic arthritis, functional deformity, acute humeral head fractures, cuff tear arthroplasty, or revision of failed treatments. Hemi-shoulder replacement indicated for ununited humeral head fractures and avascular necrosis.
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.”
DePuy® -Global Advantage Shoulder, Global Advantage Humer (K992065)
Biomet- BioModular® Shoulder Humeral Head W/Ionguard (K915596)
Zimmer- New Zimmer Shoulder System (Bigliani/FlatowTM) (K982981)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the Wright Medical Technology, Inc. logo and contact information. The logo features a stylized "W" and the company name in bold letters. Below the logo, the address "5677 Airline Road, Arlington, TN 38002" and the phone number "901-867-9971" are printed. The date "NOV 22 2000" is at the top of the image.
# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the WMT ULTRA-FITTM Modular Shoulder System.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
#### Wright Medical Technology, Inc.
August 24, 2000
Ehab M. Esmail Senior Regulatory Affairs Associate
ULTRA-FITTM Shoulder WMT Modular System
Modular Shoulder System
21 CFR 888.3660 Prosthesis, Shoulder, Semi-Constrained, metal/polymer, Cemented - Class II
21 CFR 888.3690 Prosthesis, Shoulder, Hemi-, Humeral, Metallic, Uncemented - Class II
Orthopedics/87/KWS, HSD
### Device Product Code and Panel Code:
# DEVICE INFORMATION
### A. INTENDED USE
The indications for use for the WMT ULTRA-FITTM Modular Shoulder System will be substantially equivalent to the indication for use listed under the following submissions. (Table 1 - Total Shoulder Systems Cleared for Market)
The WMT Modular Shoulder is indicated for use in shoulder arthroplasty for reduction or relief of pain and/or improved shoulder function in skeletally mature patients with sufficient and satisfactory bone stock to support the prosthesis with the following conditions:
Image /page/0/Picture/22 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, serif typeface. Below "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The logo is black and white.
Image /page/0/Picture/23 description: The image shows a globe with a stand. The globe is showing a map of the world, with the continents and oceans visible. The stand is made of metal and has a circular base. The globe appears to be old and worn.
510(K) SUMMARY
{1}------------------------------------------------
### Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis or post-traumatic arthritis;
- Revision where other devices or treatments have failed;
- Correction of functional deformity;
- Treatment of acute fracture of the humeral head unmanageable using other treatment methods; and
- Cuff tear arthroplasty.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures; and
- Avascular necrosis of the humeral head.
The humeral stem may be implanted by press-fit or cement fixation.
| Description | Submission<br>Number | Clearance<br>Date |
|--------------------------------------------------------------|----------------------|-------------------|
| WMT -Modular Shoulder System | K001706 | 08/16/2000 |
| 3MTM -Modular Shoulder System | K920362 | 07/22/1993 |
| DePuy® -Global Advantage Shoulder, Global<br>Advantage Humer | K992065 | 07/12/1999 |
| Biomet- BioModular® Shoulder Humeral<br>Head W/Ionguard | K915596 | 03/11/1992 |
| Zimmer- New Zimmer Shoulder System<br>(Bigliani/FlatowTM) | K982981 | 12/17/1998 |
### Table 1 - Total Shoulder Systems Cleared for Market Cleared for Market
The components included in the WMT ULTRA-FIT™ Modular Shoulder System are for single use only.
### B. DEVICE DESCRIPTION
The WMT ULTRA-FITTM Modular Shoulder System consists of three main components: humeral stem, humeral head, and glenoid implants. All heads will be interchangeable with all stems, and glenoids will be matched to humeral heads. The glenoids will be available in two designs: The 3M-like glenoids are identical in intended use, type of interface, material, and design features to the 3M glenoid component submitted under 3M Modular Shoulder System (Table 1: K920362, SE 07/22/1993) currently distributed by WMT; and the WMT ULTRA-FITTM Glenoids that are described below.
Image /page/1/Figure/17 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font size. The logo is simple and professional, using a clean typeface and a geometric symbol.
Image /page/1/Picture/18 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is displayed on a stand, and the continents are visible with their landmasses and geographical features. The image provides a view of the Earth from a specific perspective, highlighting the relative positions and sizes of these continents.
510(K) SUMMARY
{2}------------------------------------------------
The WMT ULTRA-FIT™ Humeral Stems will be available in four options:
- Press-fit slotted stems (4): 10,12,14,16mm X 125mm
- Cemented or press-fit non-slotted stems (7): 6, 8, 10, 12, 14, 16mm X 125mm; . 6mm X110mm
- Standard revision stems (4): 6, 8, 10, 12mm X 175mm
- Long revision stems (4): 6, 8, 10, 12mm X 225mm
The WMT ULTRA-FITTM Humeral Heads will be available in:
- 5 radii of curvature: 20, 22, 24, 26, and 28mm
- 3 heights: standard (defined by 155° to 160° arc), +3mm, and -3mm
The WMT ULTRA-FIT™ Glenoids will be available in:
- 6 radii of curvature (Keeled)
#### SUBSTANTIAL EQUIVALENCE INFORMATION C.
The intended use, material, type of interface, and design features of the WMT ULTRA-FITTM Modular Shoulder System are substantially equivalent to the competitive devices listed in Table 1. The safety and effectiveness of WMT ULTRA-FIT™ Modular Shoulder System are adequately supported by the substantial equivalence information, materials data, and testing results provided, within this. Premarket Notification.
Image /page/2/Picture/13 description: The image shows a globe with a stand. The globe is showing the continents of Asia and Australia. The globe is also showing the oceans surrounding the continents. The image is a black and white photograph.
Image /page/2/Picture/15 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" above the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the phrase "MEDICAL TECHNOLOGY, INC." in smaller, sans-serif font. The logo is simple and professional, conveying a sense of stability and innovation.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2222000
Mr. Ehab M. Esmail Senior Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K002683
K002005
Trade Name: WMT ULTRA-FIT™Modular Shoulder System Regulatory Class: II Product Code: KWS, HSD Dated: August 24, 2000 Received: August 28, 2000
#### Dear Mr. Esmail:
We have reviewed your Section 510(k) notification of intent to market the device referenced your we nave reviewed your becally in the device is substantially equivalent (for the indications for use above and we nave determined the dovices marketed in interstate commerce prior to May 28, 1976, the stated in the Enclosure) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Dovice Finenations, Drug, and Cosmetic Act (Act). Your may,
accordance with the provisions of the Federal Food, Drug, and Cosment of the seppe therefore, market the device, subject to the general control provisions of the Act. The general therefore, market the device, babyeer to ans goals for annual registration, listing of devices, control provisions of the Ave merate require requiret misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarket Apployal), it may of subject to ode of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good A substantially cquivalent determination set forth in the Quality System Regulation (QS) for Manufacturing Praction regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drug Frammeriation in regulatory action. In addition, FDA may publish Comply with the ONIT Tegatator in your device in the Federal Register. Please note: this response to your premarks contenting your submission does not affect any obligation you might It sponse to your promation nounced of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
{4}------------------------------------------------
#### Page 2 - Mr. Ehab M. Esmail
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for millionally, for questions on the promotion and advertising of your device, (301) 594-1639. Tradition for at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark N. Melburn
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
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows a logo with a stylized letter "W" on the left side. To the right of the "W" is the beginning of a word, with the letters "ME". Below the letters "ME" are the numbers "5 6" and the letters "A R".
Image /page/5/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The address is listed as 5677 Airline Road, Arlington, TN 38002. The phone number is 901-867-9971.
# INDICATIONS STATEMENT
## WMT ULTRA-FITTM Shoulder System 510(K) Number (if known): K002683
The WMT Modular Shoulder is indicated for use in shoulder arthroplasty for reduction or relief of pain and/or improved shoulder function in skeletally mature patients with sufficient and satisfactory bone stock to support the prosthesis with the following conditions:
#### Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- Rheumatoid arthritis or post-traumatic arthritis;
- Revision where other devices or treatments have failed;
- Correction of functional deformity;
- Treatment of acute fracture of the humeral head unmanageable using other treatment methods; and
- Cuff tear arthroplasty.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures; and
- Avascular necrosis of the humeral head.
The humeral stem may be implanted by press-fit or cement fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Mullen
(Division Sign-Off)
(Division Sign-Off)
Division of General Restorative Devices
K002683
Prescription Use V (Per21 CFR 801.109)
OR
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
> Over-The Counter Use (Optional Format 1-2-96)
Image /page/5/Picture/24 description: The image shows a black and white globe with a focus on the continents of Asia and Australia. The globe is surrounded by a circular band, possibly representing an orbit or a ring. The image is somewhat grainy, suggesting it may be a low-resolution scan or a photograph of a printed image. The continents are easily identifiable due to their distinct shapes and relative positions.
INDICATIONS STATEMENT
Image /page/5/Picture/26 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" above the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in smaller letters. The logo is black and white.
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.
