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, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The LINEAGE™ Acetabular System consists of metal acetabular shells and UHMWPE acetabular liners.

The LINEAGE™ Acetabular Shell will be available in a hemispherical titanium allov shell with and without a 14° peripheral rim flare. The shells will be coated with commercially pure titanium plasma spray or porous beads.

Design features of the LINEAGE™ Acetabular Shell are summarized below:
· Total hemispherical design
· Hemispherical design with 14° flare
· Coated with CP Ti plasma spray or porous beads
· Solid, quadrant, and multi-hole options
· Threaded apical hole plug

The LINEAGE™ Acetabular Liners will be available with a 0° and 15° overhangs with/without a 4+mm lateralized shift. The Liner's internal geometry will be intended to be used with our existing femoral heads manufactured from cobalt chrome or ceramic with WMT12/14 taper, Orthomet® taper and A-line taper. The LINEAGE™ Liner's external geometry will be designed to accept the LINEAGE™ Acetabular Shells.

Design features of the LINEAGE™ Acetabular Liner are summarized below:
· 360° liner overhang positioning options
· Features an 18° male taper and peripheral ring assembly to lock the liner into the acetabular shell
· The lip of the 15° liner will be machined to 210°
· The inserts will be offered with 0°and 15° overhangs
· The inserts will also be offered with a 4+mm lateralized shift
· Internal diameter will have a 2mm chamfer to minimize impingement.

The thinnest part of any UHMWPE articulating insert will be greater than 4 mm if attached to a metal or ceramic backing.

AI/ML Overview

This document is a 510(k) summary for the LINEAGE™ Acetabular System, which is a medical device. The document states that the device is substantially equivalent to competitive devices previously cleared for market, and its safety and effectiveness are supported by substantial equivalence information, materials data, and testing results. However, the document does not describe acceptance criteria, the specific study that proves the device meets those criteria, or any of the detailed information requested in your prompt.

Here's why and what information is missing:

510(k) Summaries: A 510(k) summary is not a full study report. It's a summary provided to the FDA to demonstrate substantial equivalence to a predicate device. It typically focuses on device description, intended use, and a high-level claim of substantial equivalence, often referencing internal testing or comparison to predicate devices without detailing the studies themselves.
Acceptance Criteria & Performance: The document states the device's intended use and briefly describes its components and design features. It does not provide specific objective acceptance criteria (e.g., "device must achieve X % accuracy," "wear rate must be less than Y mm/year") or report specific performance metrics against such criteria.
Study Details: There is no mention of a specific "study" in the sense of a clinical trial or a detailed performance validation study with a test set, experts, ground truth, or statistical analysis. The phrase "testing results provided within the Premarket Notification" is a general statement, not a description of a study.

Therefore, I cannot fulfill your request with the provided input. All the categories you asked for (sample size, data provenance, number of experts, adjudication, MRMC, standalone, ground truth type, training set size, training ground truth establishment) are not present in this 510(k) summary.

The primary information available is:

Device: LINEAGE™ Acetabular System (metal acetabular shells and UHMWPE acetabular liners).
Intended Use: Total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with various conditions (non-inflammatory degenerative joint disease, inflammatory degenerative joint disease, functional deformity correction, revision procedures, and treatment of certain fractures).
Claim: Substantial equivalence to previously cleared competitive devices based on intended use, material, type of interface, design features, and "testing results."
Regulatory Clearance: K002149, cleared by FDA on August 31, 2000.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the LINEAGE™ Acetabular System.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

ROAD

3800

July 11, 2000

Ehab M. Esmail Senior Regulatory Affairs Associate

LINEAGETM Acetabular System

Metal/ Polymer Acetabular Components

21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained, metal/polymer, Uncemented - Class II Orthopedics/87/LPH

Device Product Code and Panel Code:

DEVICE INFORMATION

A. INTENDED USE

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;
correction of functional deformity; 3.
revision procedures where other treatments or devices have failed, and, র্ব
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Image /page/0/Picture/25 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.

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The LINEAGETM Acetabular System are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

B. DEVICE DESCRIPTION

The LINEAGE™ Acetabular System consists of metal acetabular shells and UHMWPE acetabular liners.

Design features of the LINEAGE™ Acetabular Shell are summarized below:

· Total hemispherical design
· Hemispherical design with 14° flare
· Coated with CP Ti plasma spray or porous beads
· Solid, quadrant, and multi-hole options
· Threaded apical hole plug

Design features of the LINEAGE™ Acetabular Liner are summarized below:

· 360° liner overhang positioning options
· Features an 18° male taper and peripheral ring assembly to lock the liner into the acetabular shell
· The lip of the 15° liner will be machined to 210°
· The inserts will be offered with 0°and 15° overhangs
· The inserts will also be offered with a 4+mm lateralized shift
· Internal diameter will have a 2mm chamfer to minimize impingement.

The thinnest part of any UHMWPE articulating insert will be greater than 4 mm if attached to a metal or ceramic backing.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of the LINEAGE™ Acetabular System are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the LINEAGE™ Acetabular System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

Image /page/1/Picture/23 description: The image shows the text "510(K) SUMMARY" in a bold, serif font. The text is arranged on two lines, with "510(K)" on the first line and "SUMMARY" on the second line. The text appears to be part of a document or report.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 2000

Mr. Ehab M. Esmail Senior Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K002149

Trade Name: Lineage™ Acetabular System Regulatory Class: II Product Code: LPH Dated: July 13, 2000 Received: July 17, 2000

Dear Mr. Esmail:

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, 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). 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 adulteration.

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 Good 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 - Mr. Ehab M. Esmail

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

vonne R. Vochner

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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Page _ of _

510(k) Number (if known): K002149

LINEAGE™ Acetabular System Device Name:

Indications For Use:

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 concitions:

l ) 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;
1. revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5) with head involvement that are unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daine R. Lochner

(Division Sign-Off) Division of General Restorative Devices 510(k) Number 4002147

Prescription Use h U (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.