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.

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).

AI/ML Overview

The provided text is a 510(k) summary for the WMT Modular Shoulder System. It describes the device, its intended use, indications for use, and a summary of testing. However, it does not contain information about acceptance criteria, detailed study designs, or specific performance metrics that would be used to prove a device meets acceptance criteria in the context of an AI/ML medical device.

The "Testing Summary" section states: "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."

This statement indicates that mechanical testing was performed to demonstrate that the physical and design properties of the shoulder system are comparable to a previously cleared predicate device. It doesn't present a clinical study with quantifiable performance metrics, acceptance criteria, or ground truth as would be expected for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of an AI/ML device from this document.

If this were an AI/ML device submission, the document would typically include:

Acceptance Criteria Table: Specific thresholds for metrics like sensitivity, specificity, AUC, F1-score, accuracy, etc.
Reported Device Performance: The actual measured values from the study for those metrics.
Sample Size and Data Provenance: Details about the test set, including its size, origin (e.g., country), and whether it was retrospective or prospective.
Ground Truth Experts: Number and qualifications of experts who established the ground truth.
Adjudication Method: How disagreements among experts were resolved.
MRMC Study: Information on comparative effectiveness studies, including effect sizes.
Standalone Performance: If the algorithm was evaluated without human intervention.
Type of Ground Truth: Whether pathology, consensus, or other methods were used.
Training Set Details: Sample size and how ground truth was established for the training data.

Since this is a submission for a mechanical orthopedic implant, these types of details are not present.

Summary

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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:

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

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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.

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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

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Indications for Use Statement

KOOITOG 510(k) Number (if known)

WMT Modular Shoulder System

Device Name

Indications for Use

Intended Use

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

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Regulation Number and Section

§ 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.”