(28 days)
CONSERVE® Plus Spiked Shell
Not Found
No
The document describes a physical implant (hip shell) and its material properties and design features. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in patients with various conditions, which directly defines it as a therapeutic device aimed at treating a medical condition and improving patient well-being.
No
Explanation: The device, CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell, is an implant used in total hip arthroplasty to relieve pain and improve hip function by replacing damaged parts of the hip joint. It is a treatment device, not a diagnostic one.
No
The device description clearly indicates it is a physical implant made of cobalt-chromium-molybdenum, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in total hip arthroplasty for the reduction or relief of pain and/or improved hip function in patients with specific conditions affecting the hip joint. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "Revision Shell" and "Thick Shell" made from materials like cobalt-chromium-molybdenum, with features like porous coating, articulating surfaces, and screw holes. These are components designed to be implanted into the hip joint.
- Anatomical Site: The anatomical site is the "Hip joint," which is an internal part of the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to replace or augment a damaged hip joint.
N/A
Intended Use / Indications for Use
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are 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; and, 3.
-
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are intended for single patient use only.
Product codes
JDL, KWA
Device Description
The design features of the CONSERVE® Plus Revision Shell are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum .
- Porous coated with CoCrMo sintered beads
- The articulating surface of the implants will be superfinished .
- Offered in inner diameters ranging from 36mm-56mm .
- Increased eccentricity and offset and screw holes .
- Fins for enhanced fixation .
The design features of the CONSERVE® Plus Thick Shell are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum .
- Porous coated with CoCrMo sintered beads .
- The articulating surface of the implants will be superfinished .
- Offered in inner diameters ranging from 36mm-56mm .
- Minimum wall thickness: 5.5mm .
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)
The safety and effectiveness of this device are adequately supported by the substantial equivalence information, materials data, and testing results, provided within this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CONSERVE® Plus Spiked Shell
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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JUN 2 5 2004
Image /page/0/Picture/1 description: The image shows the text "K041425" on the top left corner and "p.1/2" on the top right corner. In the center of the image is the word "WRIGHT." in bold, uppercase letters. Below the word is a black graphic design element that looks like a stylized wing or chevron, and below that is the trademark symbol.
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 Mouren Dovies For of 1990 and Effectiveness for the CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | May 27, 2004 |
| Contact Person: | Katie Logerot |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | CONSERVE® Plus Revision Shell and |
| CONSERVE® Plus Thick Shell | |
| Common Name: | Acetabular Shell |
| Classification Name and Reference: | 21 CFR 888.3320 Hip joint metal/ metal semi- |
| constrained, with a cemented acetabular component | |
| prosthesis - Class III | |
| 21 CFR 888.3330 Hip joint metal/ metal semi- | |
| constrained, with an uncemented acetabular | |
| component prosthesis - Class III | |
| Device Product Code and Panel Code: | Orthopedics/87/JDL |
| Orthopedics/87/KWA |
DEVICE INFORMATION
A. INTENDED USE
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are 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; and, 3.
-
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are intended for single patient use only.
| headquarters | ||||
|---|---|---|---|---|
| Wright Medical Technology, Inc. | 5677 Airline Road | Arlington, TN 38002 | 901.867.9971 phone | www.wmt.com |
| international subsidiaries | ||||
| 011.32.2.378.3905 Belgium | 905.826.1600 Canada | 011.33.1.45.13.24.40 France | 011.49.4161.745130 Germany | |
| 011.39.0250.678.227 Italy | 011.81.3.3538.0474 Japan | 011.44.1483.721.404 UK |
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p.2/2
B. DEVICE DESCRIPTION
The design features of the CONSERVE® Plus Revision Shell are summarized bclow:
- Manufactured from cast cobalt-chromium-molybdenum .
- Porous coated with CoCrMo sintered beads �
- The articulating surface of the implants will be superfinished .
- Offered in inner diameters ranging from 36mm-56mm .
- Increased eccentricity and offset and screw holes .
- Fins for enhanced fixation .
The design features of the CONSERVE® Plus Thick Shell are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum .
- Porous coated with CoCrMo sintered beads .
- The articulating surface of the implants will be superfinished .
- Offered in inner diameters ranging from 36mm-56mm .
- Minimum wall thickness: 5.5mm .
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, and type of interface of the CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are identical to the CONSERVE® Plus Spiked Shell. The design features are substantially equivalent to the CONSERVE® Plus Spiked The safety and effectiveness of this device are adequately supported by the Shell. substantial equivalence information, materials data, and testing results, provided within this Premarket Notification.
Image /page/1/Picture/18 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of the word "WRIGHT" in a bold, sans-serif font, with a stylized "W" symbol above it. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The logo is simple and modern, and it conveys a sense of professionalism and innovation.
Image /page/1/Picture/19 description: The image shows a black and white drawing of a globe. The globe is tilted and shows the continents of Asia, Europe, and Africa. There is a small object below the globe, which is difficult to identify due to the image quality. The image is simple and lacks detail.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a stylized symbol. The symbol consists of three curved lines that resemble a person's profile, with the lines representing different aspects of health and human services.
Public Health Service
JUN 2 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Katie Logerot Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road, Arlington, Tennessee 38002
Re: K041425
K041423
Trade/Device Name: CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell
Regulation Number: 21 CFR 888.3320 and 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular
Regulation Name: Hip joint metal/metal semi-constrained, with a cements in a Trip John metal senia Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis
Regulatory Class: III Product Code: KWA and JDL Dated: May 27, 2004 Received: May 28, 2004
Dear Ms. Logerot:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bection of the device is substantially equivalent (for the indications referenced above and nave acteringedly marketed predicate devices marketed in interstate for use stated in the enclosury to regary to regard to the Medical Device American so to to commerce provide to May 20, 1976, the enature with the provisions of the Federal Food. Drug, devices that have been recassmen in asses approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mance the art include requirements for annual registration, listing of general controls provisions of the 120 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 If your device is elassified (500 abor of the Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controller ... Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs ocements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA 3 issualled of a substition.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a acterimisered by other Federal agencies. You must br any it cach statutes and regularents and adding, but not limited to: registration and listing (21 Comply with an the Act STequirements) and manufacturing practice requirements as set
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Page 2 – Ms. Katie Logerot
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Doctors 301 cevice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your daying to legal I his letter will anow you to ocgin manomig of substantial equivalence of your device to a legally premarket nothication. The PDA miding of backandar organ
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 If you desire specific advice for your active of the carner on one note the regulation entitled, contact the Office of Compliation at (301) of Cations (21CFR Part 807.97). You may obtain " Misbranding by reference to premarket notifical on the Act from the Division of Small other general Information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at in the manage attral Manufacturers, michiational and Oblisantety://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. McMahon
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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Indications for Use
510(k) Number (if known):
Device Name: _CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell
Indications For Use:
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are indicated for The CONSERVE® Plus Revision Silen and OOT&BA. De 2011-2017 and/or improved hip function in use in total mp artises with the following conditions:
- skorean matory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- ankylosis, protrusio accusein, a.a. pass such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- confection of functional developments or devices have failed
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are intended for single patient use only.
Prescription Use × (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)
Mark N. Melker
Division of General, Restorative, and Neurological Devices
510(k) Number K041425
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