The Patient Specific Acetabular Reconstruction Prosthesis is inlended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed below. The device is for single use and is intended for cementless application.

The Patient Specific Acetabular Reconstruction Prosthesis is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip and diastrophic variant.

Device Description

The Patient Specific Acetabular Reconstruction Prosthesis is an acetabular shell designed to match the natural geometry of an individual patient. Because each Patient Specific Acetabular Reconstruction Prosthesis component is designed to match a particular patient, taking into account his/her natural anatomy and bone stock, a specific device description is not possible.

AI/ML Overview

The provided text describes a 510(k) summary for a "Patient Specific Acetabular Reconstruction Prosthesis." This document primarily focuses on the device description, intended use, indications, and substantial equivalence to existing devices.

Crucially, the document DOES NOT contain information regarding acceptance criteria, device performance studies, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions 2 through 9 based on the input text. The 510(k) summary is a regulatory submission for premarket notification, aiming to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It typically does not include detailed performance study results in the same way a clinical trial report or a scientific publication would.

Summary

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Kogzo98

JAN 2 2 2010

510(k) Summary Patient Specific Acetabular Reconstruction Prosthesis

Smith & Nephew, Inc., Orthopaedic Division Submitter's Name: 1450 Brooks Road, Memphis, TN 38116 Submitter's Address: Submitter's Telephone Number: 901-399-5340 Megan Bevill Contact Person: Date Summary Prepared: January 22, 2010 Patient Specific Acetabular Reconstruction Prosthesis Trade or Proprietary Device Name: Common or Usual Name: Acetabular Shell Classification Name: 21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous coated uncemented prosthesis Device Class: Class II Orthopaedics/87/LPH Panel Code:

Device Description

Intended Use and Indications

The Patient Specific Acetabular Reconstruction Prosthesis is intended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed below. The device is for single use and is intended for cementless application.

Substantial Equivalence

The Patient Specific Acetabular Reconstruction Prosthesis is similar to the following commercially available devices regarding design features, overall indications, and materials:

l Contour Acetabular Rings (K962541, K040680)
R3 Acetabular System (K061253, K070756) ■
Reflection Acetabular System (K932755, K990666, K060630) 트
Patient Matched Flanged Acetabular Component (K983035, K030861) 트
Foundation Porous Acetabular System (K973119) 트

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an abstract caduceus. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

JAN 2 2 2010

Smith & Nephew, Inc. c/o Ms. Megan Bevill Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

Re: K092098

Trade/Device Name: Patient Specific Acetabular Reconstruction Prosthesis · Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: January 20, 2010 Received: January 21, 2010

Dear Ms. Bevill:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 - Ms. Megan Bevill

CFR Part 807); labeling (21 CFR Part 801); 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/CDRHQffices/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.

sincerely, years,

Mark McMullen

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

510(k) Number (if known): Koq 209 ප

Device Name: Patient Specific Acetabular Reconstruction Prosthesis

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qoutte for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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.