The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acctabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
correction of functional deformity; and, 3.
revision procedures where other treatments or devices have failed. 4.

The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision.

The DYNASTY® Acctabular Shell is for both cemented and uncemented use and is a single use device.

Device Description

The design features of the DYNASTY® Acctabular System are summarized below:

Shells manufactured from Titanium alloy, coated with CP Titanium
Shell sizes: 46mm-76mm outer diameter
Liners manufactured from UHMW Polyethylene
Polyethylene liner sizes: 28mm, 50mm, 54mm inner diameter
Liners manufactured from Cobalt Chrome alloy
Cobalt Chrome liner sizes: 52mm, 56mm inner diameter
Heads manufactured from Alumina Ceramic
Head sizes: 50mm, 54mm diameter

AI/ML Overview

The provided text is a 510(k) Summary for the DYNASTY® Acetabular System, which describes an orthopedic implant. This type of regulatory submission in the medical device industry focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics typically found for AI/ML-based software devices.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not applicable to this document.

Specifically, there is no information in the provided text about:

A table of acceptance criteria and reported device performance (as it's not an AI/ML device being evaluated for diagnostic/predictive performance).
Sample size used for a test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This 510(k) summary primarily focuses on:

Intended Use: For total hip arthroplasty in skeletally mature patients with various degenerative joint conditions, functional deformities, and revision procedures.
Device Description: Details on materials (Titanium alloy, UHMW Polyethylene, Cobalt Chrome, Alumina Ceramic) and sizes of shells, liners, and heads.
Substantial Equivalence: A statement that the device's indications for use, design features, materials, and fundamental scientific technology are "substantially equivalent" to previously cleared predicate devices. The safety and effectiveness are supported by "substantial equivalence information, materials information, and analysis data," but these specific data are not detailed in this summary.

This document is a regulatory approval document for a physical medical device, not a software as a medical device (SaMD) that relies on AI/ML and would typically have the requested performance study details.

Summary

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K082924 (pg 1/2)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR - 6 2009

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 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the DYNASTY® Acetabular System.

Submitted By:	Wright Medical Technology, Inc.
Date:	September 30, 2008
Contact Person:	Matt Paul
	Regulatory Affairs Specialist II
Proprietary Name:	DYNASTY® Acetabular System
Common Name:	Acetabular ShellAcetabular LinerFemoral Head
Classification Name and Reference:	21 CFR 888.3330 Prosthesis, hip, semi-constrained(metal uncemented acetabular component) - ClassIII
Device Product Code and Panel Code:	Orthopedics/87/KWA, JDL

DEVICE INFORMATION

A. Intended Use

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acctabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
correction of functional deformity; and, 3.
revision procedures where other treatments or devices have failed. 4.

The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision.

The DYNASTY® Acctabular Shell is for both cemented and uncemented use and is a single use device.

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K082924 (pg 2/2")

B. Device Description

The design features of the DYNASTY® Acctabular System are summarized below:

Shells manufactured from Titanium alloy, coated with CP Titanium
Shell sizes: 46mm-76mm outer diameter
Liners manufactured from UHMW Polyethylene
Polyethylene liner sizes: 28mm, 50mm, 54mm inner diameter �
Liners manufactured from Cobalt Chrome alloy .
Cobalt Chrome liner sizes: 52mm, 56mm inner diameter .
Heads manufactured from Alumina Ceramic �
Head sizes: 50mm, 54mm diameter

C. Substantial Equivalence Information

The indications for use of the DYNASTY® Acetabular System arc identical to the previously cleared predicate devices. The design features and matcrials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the DYNASTY® Acetabular System are adequately supported by the substantial equivalence information, matcrials information, and analysis data provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Matt Paul Sr. Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

MAR - 6 2009

K082924 Re:

Trade/Device Name: DYNASTY® Acetabular System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL Dated: February 4, 2009 Received: February 5, 2009

Dear Mr. Paul:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered print to May 20, 1977 y is accordance with the provisions of the Federal Food, Drug, devices that mave boon require approval of a premarket approval application (PMA). and Costinette Act (110.) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, increrere, mains of the Act include requirements for annual registration, listing of general voltable provision practice, 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 If your device is classified (600 a00 vols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I Driv issuantes spour device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must of any I catal statutes and regaranents, including, but not limited to: registration and listing (21 Colliply with an the 110t STequirements, one 801); good manufacturing practice requirements as set CFN Fart 807), adomig (21 CFR Part 820), good if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Matt Paul

This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark McMahon

Mark N. Melkerson 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): KOB2924 (pos 1/1)

Device Name: DYNASTY® Acetabular System

Indications For Use:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed

The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision.

The DYNASTY® Acetabular Shell is for both cemented and uncemented use and is a single use device.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millham

(Division Sign-Of Division of General, Restorative, and Neurological De

Page 1 of 1

510(k) Number

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.