(127 days)
Not Found
Not Found
No
The provided text describes a mechanical hip replacement system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for use in hip replacement procedures to alleviate severe pain and disability, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The Encore CLP Total Hip System is intended for hip replacement procedures to address structural damage in the hip joint, not for diagnosing conditions. It is a prosthetic device for treatment.
No
The device description and intended use clearly describe a physical hip implant system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant (a total or partial hip replacement system) used in vivo (within the body) to treat structural damage in the hip joint.
- Device Description (though not found): The name "Encore CLP Total Hip System" and "Encore CLP Offset Hip Stem" strongly suggest a physical implant.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Encore CLP Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post - traumatic arthritis, collagen disorders, avascular necrosis, Protrusio Acetabuli, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip displasia, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The Encore CLP Offset Hip Stem is intended for Cementless Applications
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three horizontal lines forming its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEC 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sam Son Vice President, Research and Development Official Correspondent Encore Medical Corporation 11201 Pepper Road Hunt Valley, Maryland 21031
Re: K052320
Trade/Device Name: Encore CLP™ Offset Total Hip System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Regulatory Crass: ***************************************************************** Dated: December 9, 2005 Received: December 12, 2005
Dear Mr. Son:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your boother is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreated to the Medical Device Amendments, or to devices that provision with the provisions with the provisions of the Federal Food, Drug, and Cosmetic nave boon roctablished in and require approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mancer 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 n your device to such additional controls. Existing major regulations affecting your device can be may be subject to sail adall Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or that t Dry has mude a averaulations 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 latoring (DS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Son
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally premaired notification: "The PDF manily sification 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 II you desire specific at rice for your acc (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Comphanes and et notification" (21CFR Part 807.97). You may obtain other IMISoranding of reference to psystemsibilities under the Act from the Division of Small of general information on your responsibilities at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark M. Milliams
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Food and Drug Administ
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a symbol on the left and the text "Department of Health and Human Services" on the right. The symbol is a stylized representation of a human figure, and the text is in a simple, sans-serif font. The logo is black and white.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Rev. 2, 12/21/05
Indications for Use
510(k) Number (if known): K052320
Device Name: Encore CLP Offset Total Hip System
Indications for Use:
The Encore CLP Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post - traumatic arthritis, collagen disorders, avascular necrosis, Protrusio Acetabuli, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip displasia, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The Encore CLP Offset Hip Stem is intended for Cementless Applications
Prescription Use _ V (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
Center for Devices and Radiological; Health estorative and Nearology
K052320
510(k) Number__