(104 days)
Not Found
No
The summary describes a mechanical implant (acetabular cup) and its mechanical testing, with no mention of AI or ML technologies.
Yes
The device is an implant for total hip arthroplasty, which is a procedure designed to relieve pain and improve hip function, aligning with the definition of a therapeutic device.
No
The device is an implantable medical device (acetabular cup) used in total hip arthroplasty, which is a treatment, not a diagnostic procedure. Its intended use is to reduce pain and improve hip function, not to diagnose a condition.
No
The device description clearly states it is a monoblock acetabular cup manufactured from CoCr alloy with a cpTi coating, indicating it is a physical implant, not software.
Based on the provided information, the CONSERVE® BioFoam® Shells are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for use in cementless total hip arthroplasty for the reduction or relief of pain and/or improved hip function. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implantable device (acetabular cup) made from CoCr alloy with a cpTi coating.
- Testing: The testing described is mechanical testing (frictional torque, fatigue, tensile, corrosion, wear), which is relevant for the performance and durability of an implantable device, not for analyzing biological samples in vitro.
- Anatomical Site: The anatomical site is the hip, indicating a device used within the body.
In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The CONSERVE® BioFoam® Shells do not perform this function. They are a surgical implant.
N/A
Intended Use / Indications for Use
The CONSERVE® BioFoam® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
- 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® BioFoam® Shell is intended for cementless hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
KWA
Device Description
Design features of the shells are summarized below:
. Monoblock acetabular cup
. Available in 11 sizes
. Manufactured from CoCr alloy with a cpTi coating
The CONSERVE® BioFoam® Shells were evaluated via mechanical testing; including frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing. A review of these results indicates that the CONSERVE® BioFoam® Shells are equivalent to predicate devices.
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)
The CONSERVE® BioFoam® Shells were evaluated via mechanical testing; including frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing. A review of these results indicates that the CONSERVE® BioFoam® Shells are equivalent to predicate devices.
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.
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
§ 888.3330 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
KI10029
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 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the CONSERVE® BioFoam® Shell.
| Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd, Arlington TN, 38002
(800) 238-7188 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 31, 2010 |
| Contact Person: | Danielle Mueller
Regulatory Affairs Specialist II |
| Proprietary Name: | CONSERVE® BioFoam® Shell |
| Common Name: | Acetabular Cup |
| Classification Name and Reference: | 888.3330 Hip joint metal/metal semi-
constrained, with an uncemented acetabular
component prosthesis |
| Subject Product Code and Panel Code: | Orthopedics/87/KWA |
| Predicate Devices: | Metal TRANSCEND® Articulation System
CONSERVE® Plus Spiked Shells and 56mm
DYNASTY® Acetabular System
510(k)s: K021349, K031963, K082924 |
DEVICE INFORMATION
A. Intended Use
The CONSERVE® BioFoam® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
- 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® BioFoam® Shell is intended for cementless hip arthroplasty.
Page 1 of 2
1
B. Device Description
Design features of the shells are summarized below:
- . Monoblock acetabular cup
- . Available in 11 sizes
- . Manufactured from CoCr alloy with a cpTi coating
The CONSERVE® BioFoam® Shells were evaluated via mechanical testing; including frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing. A review of these results indicates that the CONSERVE® BioFoam® Shells are equivalent to predicate devices.
C. Substantial Equivalence Information
The indications for use of the CONSERVE® BioFoam® Shells 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 devices has not changed relative to the predicate devices. The safety and effectiveness of the CONSERVE® BioFoam® Shells are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 9 2011
Wright Medical Technology, Inc. % Ms. Danielle Mueller Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K110029 Trade/Device Name: CONSERVE® BioFoam® Shells 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 Dated: December 31, 2010 Received: January 19, 2011
Dear Ms. Mueller:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Ms. Danielle Mueller
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
AS B. R
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): (( | | 0029
Device Name: CONSERVE® BioFoam® Shells
Indications For Use:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed. 4.
The CONSERVE® BioFoam® shell is intended for cementless 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)
for M. Melleuson
(Division Sign-Of!) (Division Signical, Orthopedic, and Restorative Devices
510(k) Number K110029
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