(72 days)
Not Found
No
The 510(k) summary describes a mechanical shoulder implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a shoulder arthroplasty system intended to treat various conditions like degenerative joint disease, rheumatoid arthritis, fractures, and requires implantation, which fall under the scope of therapeutic interventions.
No
The device is a modular shoulder system, an implantable prosthetic device for total or hemi-arthroplasty of the shoulder. Its intended uses are for treating various conditions of the shoulder joint by replacing it, not for diagnosing them.
No
The device description clearly outlines physical components (humeral heads, stems, flanges) made from materials like titanium alloy and cobalt chrome, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a surgical implant used to replace parts of the shoulder joint. It is implanted directly into the body to restore function and alleviate pain caused by various conditions.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device itself is the treatment.
Therefore, based on the provided information, the WMT Modular Shoulder System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The WMT Modular Shoulder System, humeral head and stem, is intended for use as a total or hemi-arthroplasty. When used for total shoulder arthroplasty, the subject components are recommended for use with 3M Neer IITM Shoulder (K895226, SE 11/3/89) compatible glenoid components.
Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and . avascular necrosis;
- . Rheumatoid 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 (comma separated list FDA assigned to the subject device)
KWS, HSD
Device Description
The WMT Modular Shoulder System includes humeral heads in five sizes. A regular length and long length humeral stem are available in identical diameters. Both humeral stems have four proximal flanges: one lateral, two anterior/posterior and one medial. The lateral flange has three suture holes and the anterior/posterior fins have one suture hole each. Both the regular and long stems are manufactured from titanium alloy (ASTM F 136). The heads are manufactured from cobalt chrome (ASTM F 1537, warm worked or ASTM F 799).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
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)
The WMT Modular Shoulder System was declared substantially equivalent to the predicate device. Mechanical test data demonstrated that the material and subject device design meet the strength requirements of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
3M Modular Shoulder System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
AUG 1 6 2000
Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in a serif font. Below the company name is the address "5677 Airline Road, Arlington, TN 38002" and the phone number "901-867-9971".
510K Summary
Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 Contact Person: Lynne Witkowski Date: June 2, 2000 Trade Name: WMT Modular Shoulder System Common Name: Shoulder prosthesis Predicate Device: 3M Modular Shoulder System
Description/Intended Use:
The WMT Modular Shoulder System includes humeral heads in five sizes. A regular length and long length humeral stem are available in identical diameters. Both humeral stems have four proximal flanges: one lateral, two anterior/posterior and one medial. The lateral flange has three suture holes and the anterior/posterior fins have one suture hole each. Both the regular and long stems are manufactured from titanium alloy (ASTM F 136). The heads are manufactured from cobalt chrome (ASTM F 1537, warm worked or ASTM F 799).
Intended Use:
The WMT Modular Shoulder System, humeral head and stem, is intended for use as a total or hemi-arthroplasty. When used for total shoulder arthroplasty, the subject components are recommended for use with 3M Neer IITM Shoulder (K895226, SE 11/3/89) compatible glenoid components.
Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and . avascular necrosis;
- . Rheumatoid 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.
Testing Summary:
The WMT Modular Shoulder System was declared substantially equivalent to the predicate device. Mechanical test data demonstrated that the material and subject device design meet the strength requirements of the predicate device.
000069
1
Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings or feathers.
Public Health Service
AUG 1 6 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K001706
Trade Name: WMT Modular Shoulder System Regulatory Class: II Product Codes: KWS and HSD Dated: May 31, 2000 Received: June 5, 2000
Dear Ms. Witkowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 0976, the enactment date of the Medical Device Amendments, or to devices that have been reclassify, in i accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and of doriotics,
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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current on one Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 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.
2
Page 2 - Ms. Lynne Witkowski
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific davice for your do ic devices), please contact the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, (201) 594-4637. Rudhionary, for questions 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 Information on your responsionales and in the more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
e R. lochner
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
3
Indications for Use Statement
KOOITOG 510(k) Number (if known)
WMT Modular Shoulder System
Device Name
Indications for Use
Intended Use
The WMT Modular Shoulder System, humeral head and stem, is intended to be used for total or hemi-arthroplasty. When used for total shoulder arthroplasty, the subject components are to be used with shoulder artill oplaar glenoid components cleared in K920362 or with 3M Neer IITM Shoulder (K895226, SE 11/3/89) compatible glenoid components.
Indications for Use:
- Non-inflammatory degenerative joint disease including . osteoarthritis and avascular necrosis;
- Rheumatoid 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) | |
|---|---|
| Dune R. Lochnes. | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number K001706 | |
| Prescription Use | |
| (per 21 CFR 801.109) ✓ | OR Over-The Counter Use |
000018