(128 days)
Metal TRANSCEND® Articulation Monoblock Shell, Metal TRANSCEND® Femoral Head (Larger Sizes)
Not Found
No
The document describes a mechanical implant (hip replacement components) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The intended use explicitly states the device is indicated for the reduction or relief of pain and/or improved hip function in patients with various conditions, which aligns with the definition of a therapeutic device.
No
The device is an implantable medical device used in total hip arthroplasty, not a device used to diagnose a condition.
No
The device description clearly details physical components made of cobalt-chromium-molybdenum, which are implanted during surgery. This indicates a hardware medical device, not a software-only one.
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 to address conditions like osteoarthritis, rheumatoid arthritis, and functional deformities. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details the materials and design of implants (acetabular shells and femoral heads) that are surgically placed within the hip joint.
- Anatomical Site: The anatomical site is the hip joint, which is part of the human body.
- Intended User / Care Setting: The intended user is a surgeon performing a surgical procedure.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head 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,
-
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only.
Product codes
KWA, JDL
Device Description
The design features of the CONSERVE® Plus Spiked Shell are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
- Porous coated with CoCrMo (ASTM F75) Sintered beads
- Available sizes: 36mm-56mm ID; available in two shell thicknesses 3.5mm and ● 4.5mm
- . The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish
- A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while ● removing very little bone to accommodate a larger Femoral Head
- Spikes are added to the outer surface to enhance fixation .
The design features of the CONSERVE® Total 56mm Femoral Head are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75 ●
- Available size: 56mm .
- Available neck lengths: -3.5, 0, +3.5 ●
- The articulating surface of the implants will be superfinished to insure form tolerance ● and a fine surface finish
- The taper connection for the CONSERVE® Total 56mm Femoral Head will be . identical to the Metal TRANSCEND® Femoral Heads Larger Sizes and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Metal TRANSCEND® Articulation Monoblock Shell, Metal TRANSCEND® Femoral Head (Larger Sizes)
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.
0
Ko31963 p.1/2
OCT 3 1 2003
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 CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head.
Submitted Bv:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc.
June 23, 2003
Katie Logerot Regulatory Affairs Associate
CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head
Spiked Acetabular Shell and Femoral Head
21 CFR 888.3320 Hip joint metal/ metal semiconstrained, with a cemented acetabular component prosthesis - Class III
21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with an uncemented acetabular component prosthesis - Class III
Device Product Code and Panel Code:
Orthopedics/87/KWA
Orthopedics/87/JDL
DEVICE INFORMATION
A. INTENDED USE
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Fernoral Head 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 theumatoid arthritis; 2.
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
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 Belglum 011.39.0250.678.227 Italy
905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK
011.49.4161.745130 Germany
1
KO31963
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only.
B. DEVICE DESCRIPTION
The design features of the CONSERVE® Plus Spiked Shell are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
- Porous coated with CoCrMo (ASTM F75) Sintered beads
- Available sizes: 36mm-56mm ID; available in two shell thicknesses 3.5mm and ● 4.5mm
- . The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish
- A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while ● removing very little bone to accommodate a larger Femoral Head
- Spikes are added to the outer surface to enhance fixation .
The design features of the CONSERVE® Total 56mm Femoral Head are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75 ●
- Available size: 56mm .
- Available neck lengths: -3.5, 0, +3.5 ●
- The articulating surface of the implants will be superfinished to insure form tolerance ● and a fine surface finish
- The taper connection for the CONSERVE® Total 56mm Femoral Head will be . identical to the Metal TRANSCEND® Femoral Heads Larger Sizes and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, and type of interface of the CONSERVE® Plus Spiked Shells are identical to the Metal TRANSCEND® Articulation Monoblock Shell. The design features are identical with the exception of additional spikes, a thinner wall, and a larger size offering. The CONSERVE® Total 56mm Femoral Head is a size addition to the Metal TRANSCEND® Femoral Head (Larger Sizes). The design features of the CONSERVE® Total 56mm Femoral Head are identical to the design features of the Metal TRANSCEND® Femoral Head (Larger Sizes). The safety and effectiveness of this device are adequately supported by the substantial equivalence information, materials data, testing results, and clinical data provided within this Premarket Notification.
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Image /page/1/Picture/20 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 the word "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, underlined by a thin line.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
Ms. Katie Logerot Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road, Arlington, Tennessee 38002
Re: K031963
Trade/Device Name: CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head
Regulation Number: 21 CFR 888.3320 and 888.3330
Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis
Regulatory Class: III Product Code: KWA and JDL Dated: September 30, 2003 Received: October 1, 2003
Dear Ms. Logerot:
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 - Ms. Katie Logerot
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Mulkerson
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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CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head
INDICATIONS STATEMENT
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head 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,
-
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
Division of General Restorative Devices
R. Mark N. Milken
eral. Rest rative ical Devices
510(k) Number _
(Division Sign-Off)
510(k) Number
headquarters Wright Medical Technology, Inc.
5677 Airline Road Arlington, TN 36002 901.867.9971 phone www.wmt.com
international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
905,826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK
011.49.4161.745130 Germany