(45 days)
Not Found
Not Found
No
The device description focuses on the physical components and design features of a total hip arthroplasty system (shells and liners) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes.
The device is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function, which clearly describes a therapeutic purpose.
No
This device is described as an acetabular system consisting of shells and liners for total hip arthroplasty, which is a treatment, not a diagnostic tool.
No
The device description clearly outlines physical components made of metal and UHMWPE, which are hardware. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating conditions affecting the hip joint. It is used in the body to replace or repair damaged tissue.
- Device Description: The device is described as a system of metal acetabular shells and UHMWPE acetabular liners, which are physical components designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / 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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LPH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a logo with the text "AUG 31 2000" above it. The logo is a stylized "W" shape. To the right of the logo, the text "WRIGHT MEDICAL TECHNOLOGY" is displayed, along with the address "5677 AIRLINE ARLINGTON, TN" and the phone number "901-867-99".
Image /page/0/Picture/1 description: The image shows the number 000012. The number is printed in a bold, sans-serif font. The numbers are slightly distressed, giving them a vintage or worn look. The background is plain and white.
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:
-
- 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; 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.
Image /page/0/Picture/26 description: The image shows a globe with a map of the world on it. The globe is mostly white and gray, with some darker areas representing landmasses. The map shows the continents of Asia, Europe, and Africa. The globe is sitting on a stand, and there is a black arm extending from the top of the globe.
1
000013
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.
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.
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.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three swooping lines, resembling an abstract representation of a bird or a wave.
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.
3
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
4
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;
-
- 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 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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)