The PROFEMUR® LX 5/8 Coated Hip Stem 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:

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 PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

Device Description

The design features of the PROFEMUR® LX 5/8 Coated Hip Stem are summarized below:

Manufactured from titanium alloy (Ti6A14V) ●
Proximal 5/8 of stem plasma sprayed .
. Offered in Sizes 10-18
Polished distal tip and collar .
Threaded hole with slot impaction mechanism .

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the PROFEMUR® LX 5/8 Coated Hip Stem. However, it does not contain any information regarding specific acceptance criteria, performance studies, or test methodologies typically associated with device performance evaluations, especially for AI/ML-based devices.

This document focuses on:

Device Identification: Proprietary name, common name, classification, product code.
Intended Use: Specific conditions for which the hip stem is indicated in total hip arthroplasty (e.g., osteoarthritis, rheumatoid arthritis, revision procedures).
Device Description: Material (titanium alloy), coating (plasma sprayed), sizes, polished features, and impaction mechanism.
Substantial Equivalence: A statement that the device is substantially equivalent to previously cleared predicate devices based on identical indications for use, similar design features, and materials. It explicitly states that "The fundamental scientific technology of the modified device has not changed relative to the predicate devices."
FDA Communication: The FDA's letter confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information in the table format or answer the specific questions (2-9) about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

The document makes no mention of AI, machine learning, or any performance metrics that would require the types of studies outlined in your request (e.g., MRMC studies, standalone algorithm performance). It is a traditional medical device submission for a physical implant.

Summary

{0}------------------------------------------------

K081090 (pg 1/2)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAY 15 2008

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 PROFEMUR® LX 5/8 Coated Hip Stem.

Submitted By:	Wright Medical Technology, Inc.
Date:	February 28, 2008
Contact Person:	Ryan RossRegulatory Affairs Specialist
Proprietary Name:	PROFEMUR® LX 5/8 Coated Hip Stem
Common Name:	Hip Stem
Classification Name and Reference:	21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabularcomponent prosthesis - Class III

Device Product Code and Panel Code:

Orthopedics/87/ KWA. LZO. MBL

DEVICE INFORMATION

A. Intended 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 PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

{1}------------------------------------------------

KOBIO90 (pg 212)

B. Device Description

The design features of the PROFEMUR® LX 5/8 Coated Hip Stem are summarized below:

Manufactured from titanium alloy (Ti6A14V) ●
Proximal 5/8 of stem plasma sprayed .
. Offered in Sizes 10-18
Polished distal tip and collar .
Threaded hole with slot impaction mechanism .

C. Substantial Equivalence Information

The indications for use of the PROFEMUR® LX 5/8 Coated Hip Stem are identical to the previously cleared predicate devices. The design features and materials 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 PROFEMUR® LX 5/8 Coated Hip Stem is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus, which is a staff entwined with snakes, representing medicine and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Ryan Ross Regulatory Affairs Specialist 5677 Airline Road Arlington, TN 38002

MAY 15 2008

K081090 Re: Trade/Device Name: PROFEMUR® LX 5/8 Coated Hip Stem 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, LZO, MBL Dated: April 14, 2008 Received: April 18, 2008

Dear Mr. Ross:

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 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.

{3}------------------------------------------------

Page 2 - Mr. Ryan Ross

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 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 N. Milliman

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K081090 (pcs) / 1 )

Device Name: PROFEMUR® LX 5/8 Coated Hip Stem

Indications For Use:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. 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 PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total 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)

Milke Oil for men

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K081090

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.