The DYNASTY® BIOFOAM® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and,
revision procedures where other treatments or devices have failed.
The DYNASTY® BIOFOAM® Shell is intended for cementless hip arthroplasty.

Device Description

Design features of the shells are summarized below:

Shells manufactured from Titanium alloy substrate, coated with BIOFOAM® coating ● manufactured from commercially pure (CP) titanium
Solid shell sizes: 46mm-68mm outer diameter
Three different hole patterns:
10-hole shell sizes: 46mm-76mm outer diameter
3-hole shell sizes: 46mm-68mm outer diameter
5-hole shell sizes: 46mm-50mm outer diameter

AI/ML Overview

The provided text is a 510(k) summary for the DYNASTY® BIOFOAM® Shell, an acetabular cup for hip arthroplasty. It focuses on demonstrating substantial equivalence to predicate devices rather than reporting the results of a primary clinical study with acceptance criteria and device performance. Therefore, the requested information about acceptance criteria and study details cannot be fully extracted from the provided text.

Specifically, the document states:

"The subject DYNASTY® BIOFOAM® Shells were cleared in K121544 for use with metal/metal bearings. The shells are identical to shells in K082924, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results concludes that the DYNASTY® BIOFOAM® Shells were cleared in K121544 and are equivalent to predicate devices."
"The safety and effectiveness of the subject DYNASTY® BIOFOAM® Shells are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

This indicates that the device was evaluated through bench testing (post-impaction analysis of clearance, form, and frictional torque) and comparison to predicate devices, not through a clinical study that would establish clinical acceptance criteria and report device performance in human subjects.

Therefore, most of the requested fields related to a clinical study (sample size, data provenance, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set details) are not applicable or not provided in this type of regulatory submission.

However, based on the provided text, here's what can be inferred or stated:

Acceptance Criteria and Device Performance (Bench Test/Equivalence)

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Substantial equivalence to predicate devices (K121544 and K082924) with respect to safety and effectiveness.	The DYNASTY® BIOFOAM® Shells were found to be equivalent to predicate devices after evaluation of post-impaction analysis of clearance, form, and frictional torque.
Acceptable post-impaction analysis of clearance.	Demonstrated acceptable clearance post-impaction.
Acceptable post-impaction analysis of form.	Demonstrated acceptable form post-impaction.
Acceptable post-impaction analysis of frictional torque.	Demonstrated acceptable frictional torque post-impaction.

**Study Details (for this 510(k) submission):**

Sample size used for the test set and the data provenance: Not applicable for a clinical test set. The evaluation involved bench testing (post-impaction analysis) of the device components. The data provenance would be internal laboratory testing by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench testing is typically based on engineering specifications and physical measurements, not expert clinical interpretation.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (hip implant) 510(k), not an AI diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For the bench testing, the "ground truth" would be the engineering specifications and measurable physical properties of the device (clearance, form, frictional torque) compared against established design parameters or predicate device performance.
The sample size for the training set: Not applicable for this type of submission. There is no mention of an algorithm or training set.
How the ground truth for the training set was established: Not applicable.

Summary

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OCT 22 2012

1.42

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K122382

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® BIOFOAM® Shell.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc. 5677 Airline Rd, Arlington TN, 38002 (800) 238-7188

July 25, 2012

Dean Nachtrab Regulatory Affairs Specialist

DYNASTY® BIOFOAM® Shell

Acetabular Cup

888.3353 Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Class II

888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis Class II

888.3350 Hip joint metal/polymer semiconstrained cemented prosthesis Class II

Orthopedics/87/ LZO. MBL. JDI

DYNASTY® Acetabular System 510(k)s: K082924

Subject Product Code and Panel Code:

Predicate Devices:

DEVICE INFORMATION

A. Intended Use

The DYNASTY® BIOFOAM® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

】. 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;
correction of functional deformity; and, 3.
1. revision procedures where other treatments or devices have failed

B. Device Description

Design features of the shells are summarized below:

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K122382

Shells manufactured from Titanium alloy substrate, coated with BIOFOAM® coating ● manufactured from commercially pure (CP) titanium
Solid shell sizes: 46mm-68mm outer diameter
Three different hole patterns:
10-hole shell sizes: 46mm-76mm outer diameter
3-hole shell sizes: 46mm-68mm outer diameter
5-hole shell sizes: 46mm-50mm outer diameter

The subject DYNASTY® BIOFOAM® Shells were cleared in K121544 for use with metal/metal bearings. The shells are identical to shells in K082924, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results concludes that the DYNASTY® BIOFOAM® Shells were cleared in K121544 and are equivalent to predicate devices.

C. Substantial Equivalence Information

The indications for use of the subject DYNASTY® BIOFOAM® Shells, cleared in K121544 for use with metal/metal bearings, are identical to shells in K082924. The design features and materials of the subject devices are substantially equivalent to those shells cleared under K082924. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the subject DYNASTY® BIOFOAM® Shells are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

2062

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT. 22 2012

Wright Medical Technology, Incorporated % Mr. Dean Nachtrab Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K122382

Trade Name: DYNASTY® BIOFOAM® Shell Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Regulatory Class: II

Product Code: MBL, LZO, JDI Dated: September 24, 2012 Received: September 24, 2012

Dear Mr. Nachtrab:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976; the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2- Mr. Dean Nachtrab

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K122382 510(k) Number (if known):

Device Name: DYNASTY® BIOFOAM® Shell

Indications For Use:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, 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 DYNASTY® BIOFOAM® Shell is intended for cementless hip arthroplasty.

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)

Atb

(Division Sign-Oit) Division of Surges), Orthopedic, and Restorative Devices

K122382 510(k) Number _

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.