(86 days)
No
The summary describes a mechanical shoulder implant system with various component options. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is indicated for the reduction or relief of pain and/or improved shoulder function, which are therapeutic outcomes.
No
The device description clearly states it is a shoulder replacement system (humeral stem, humeral head, and glenoid implants), used for treating conditions like osteoarthritis and fractures, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components (humeral stem, humeral head, glenoid implants) made of materials intended for surgical implantation, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The WMT Modular Shoulder is a prosthetic implant designed to replace components of the shoulder joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to treat various shoulder conditions by replacing damaged joint components, not by analyzing biological specimens.
The description clearly indicates a surgical implant, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
KWS, HSD
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. 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)
The components included in the WMT ULTRA-FIT™ Modular Shoulder System are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001706, K920362, K992065, K915596, K982981
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
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.”
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
Number | Clearance
Date |
|--------------------------------------------------------------|----------------------|-------------------|
| WMT -Modular Shoulder System | K001706 | 08/16/2000 |
| 3MTM -Modular Shoulder System | K920362 | 07/22/1993 |
| DePuy® -Global Advantage Shoulder, Global
Advantage Humer | K992065 | 07/12/1999 |
| Biomet- BioModular® Shoulder Humeral
Head W/Ionguard | K915596 | 03/11/1992 |
| Zimmer- New Zimmer Shoulder System
(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.