(92 days)
Not Found
No
The summary describes a modification to a porous coating method for hip implants and does not mention any AI or ML technology.
Yes
The device is a joint replacement for the hip, which is used to treat diseases and conditions that cause disability. This aligns with the definition of a therapeutic device as it is intended to alleviate or cure a medical condition.
No
Explanation: The device is a hip joint replacement, which is a therapeutic device used to treat joint disease and functional deformities, not to diagnose them.
No
The device description explicitly states the modification is an "additional method of porous coating" on hip devices, indicating a physical modification to a hardware component (the hip implant). 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/Indications for Use: The intended use describes the device's application in treating joint conditions and correcting deformities through surgical implantation. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a modification of hip replacement components, which are surgically implanted medical devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to diagnose or monitor conditions. This device is clearly intended for in vivo (inside the body) use as a surgical implant.
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.
Product codes
LPH
Device Description
The modification consists of an additional method of porous coating currently conducted on the hip devices listed above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Joint (Hip)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K072888 (Pa 1/1)
Summary of Safety and Effectiveness
Date: December 14, 2007
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: JAN 1 0 2008 Teffany Hutto Manager, 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® Porous Coated (FMPTM) Acetabular | ||||
| Shells (Spiked, Hemispherical, and Flared) | K974093, K974095, and K973119 – | |||
| January 28, 1998 | ||||
| Class II | LPH | LPH | Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis per 21 CFR 888.3358 |
The modification consists of an additional method of porous coating currently Description: conducted on the hip devices listed above.
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.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
JAN 1 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, TX 78758
Re: K072888 Trade/Device Name: Foundation® Porous Coated (FMPTM) Acetabular Shells 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 14, 2007 Received: December 18, 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Mulhearn
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): K072888 (pg 1/
Device Name: Foundation® Porous Coated (FMP) Acetabular Shells
Indications for Use:
Foundation® Porous Coated (FMPTM) Acetabular Shells 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.
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)
ubne buclind for nixon
Division of General. Restorative. and Neurological Devices
510(k) Number K072888
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