(133 days)
Not Found
No
The summary describes a material and size modification to an existing joint replacement device and does not mention any AI or ML components or functionalities.
Yes
The device is a joint replacement, which is a therapeutic intervention for patients suffering from joint diseases and injuries, aiming to correct functional deformity and alleviate disability.
No
The device is described as an acetabular liner and related components for joint replacement surgery, indicated for treating various joint diseases and fractures. This is a therapeutic device, not one used for diagnosis.
No
The device description clearly states it is a modification to a physical acetabular liner and includes size additions to physical components (liners, shells, femoral heads). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states this device is a modification to an acetabular liner, acetabular shells, and femoral heads, which are components of a joint replacement for the hip. These are implanted devices used within the body, not for testing specimens outside the body.
- Intended Use: The intended use describes the conditions for which the joint replacement is indicated (osteoarthritis, rheumatoid arthritis, etc.). This is a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, this device is a surgical implant and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity;
- femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used for cementless applications only.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The modification consists of a change to Encore Medical's acetabular liner to from Description: UHMWPe to highly cross-linked UHMWPe. Additionally, this application addresses a size addition to Encore Medical's current acetabular liners, acetabular shells, and femoral heads.
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
Not Found
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.
K974093, K974095, K973119, K973302
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
Summary of Safety and Effectiveness
Date: December 10, 2007
DEC 1 4 2007
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manger, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com
| Product | 510(k) Number, Clearance Date, Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Foundation® (FMPTM) Porous Coated Spiked Acetabular System | K974093, January 28, 1998, Class II | LPH | LPH | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR 888.3358 |
| Foundation® (FMPTM) Porous Coated Hemispherical Acetabular System | K974095, January 28, 1998, Class II | LPH | ||
| Foundation® (FMPTM) Porous Coated Flared Rim Acetabular System | K973119, January 28, 1998, Class II | LPH | ||
| Foundation® Press Fit (Porous Coated) Hip Stem | K973302 - December 2, 1997, Class II | LPH |
The modification consists of a change to Encore Medical's acetabular liner to from Description: UHMWPe to highly cross-linked UHMWPe. Additionally, this application addresses a size addition to Encore Medical's current acetabular liners, acetabular shells, and femoral heads.
Joint replacement is indicated for patients suffering from disability due to:
- . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- . rheumatoid arthritis;
- correction of functional deformity; ●
- femoral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used for cementless applications only.
Intended Use - Encore Medical hip devices are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. While hip replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, and indications for use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Encore Medical, L.P. Co Ms. Teffany Hutto Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
DEC 1 4 2007
Re: K072154 Trade/Device Name: Foundation® (FMP™) Porous Coated Acetabular System (Spiked, Hemispherical, Flared Rim) and Foundation® Press Fit (Porous Coated) Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: December 6, 2007 Received: December 7, 2007
Dear Ms. Hutto:
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.
2
Page 2 - Ms. Teffany Hutto
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K072154
Device Name: Acetabular System
Indications for Use:
FMP™ Acetabular System (Spiked, Hemispherical, Flared Rim) Foundation® Porous Coated Hip Stem
Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the ◆ natural femoral head;
- . rheumatoid arthritis;
- . correction of functional deformity;
- femoral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used for cementless applications only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Poto Amm
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number L072154