(82 days)
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No
The summary describes a line extension for femoral heads and focuses on engineering analysis for substantial equivalence, with no mention of AI/ML terms or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No.
The device is a component of an orthopedic implant (femoral heads) used for joint replacement, which is a structural device, not one that delivers therapy (e.g., drug, energy, or biological treatment).
No
The device description indicates it is a line extension for femoral head components used in reconstructive procedures, not for diagnosing conditions. The "Intended Use" section lists conditions that the device treats (e.g., osteoarthritis, rheumatoid arthritis), not conditions it diagnoses.
No
The device description clearly states it is a line extension adding physical components (36mm femoral heads) to an existing hardware device (PCA® Femoral Head Components).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures related to joint replacement and repair (treating conditions like osteoarthritis, rheumatoid arthritis, fractures, etc.). This is a therapeutic and structural function within the body.
- Device Description: The device is described as "femoral heads," which are components of a hip implant. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are single use, sterile femoral heads intended to be used as a modular component as part of a femoral prosthesis. The indications for use for the PCA® 36mm Femoral Heads follow.
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis;
- . Rheumatoid arthritis (except the Osteolock™ HA Acetabular Cup):
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and, .
- Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
87 JDI, 87 LPH
Device Description
This 510(k) submission is a line extension intended to add 36mm femoral heads to the PCA® Femoral Head Components.
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
Femoral
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject PCA® 36mm Femoral Heads share the same design, intended use, performance, materials, and operational principle as that of the currently available PCA® Femoral Heads. An engineering analysis demonstrated the subject device falls within pre-established acceptance criteria of the predicate components and are substantially equivalent to these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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K061168 (pg 1 of 2
Summary of Safety and Effectiveness PCA® 36mm Femoral Heads
PCA® 36mm Femoral Heads Proprietary Name: Common Name: Modular Femoral Head Components Classification Name and Reference: Hip joint metal/polymer semi-constrained cemented prosthesis, 21 CFR §888.3350 Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis, 21 CFR 6888,3358 Device Product Code: 87 JDI, 87 LPH For Information Contact: Francisco Haro, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5493
Date Summary Prepared:
Description:
This 510(k) submission is a line extension intended to add 36mm femoral heads to the PCA® Femoral Head Components.
Fax: (201) 831-6038
April 27, 2006
Intended Use:
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are single use, sterile femoral heads intended to be used as a modular component as part of a femoral prosthesis. The indications for use for the PCA® 36mm Femoral Heads follow.
Indications for Use:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis;
- . Rheumatoid arthritis (except the Osteolock™ HA Acetabular Cup):
- . Correction of functional deformity;
1
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7
- Revision procedures where other treatments or devices have failed; and, .
- Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
Substantial Equivalence:
The subject PCA® 36mm Femoral Heads share the same design, intended use, performance, materials, and operational principle as that of the currently available PCA® Femoral Heads. An engineering analysis demonstrated the subject device falls within pre-established acceptance criteria of the predicate components and are substantially equivalent to these devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures in profile, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 18 2006
Howmedica Osteonics Corporation c/o Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K061168
Trade/Device Name: PCA® 36mm Femoral Heads 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, JDI Dated: May 26, 2006 Received: May 30, 2006
Dear Mr. Haro:
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
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Page 2 - Mr. Francisco Haro
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. 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K061168
510(k) Number (if known):
Device Name: PCA® 36mm Femoral Heads
Indications for Use:
- Noninflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
- Rheumatoid arthritis (except the Osteolock™ HA Acetabular Cup); .
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; and, .
- Nonunions, femoral neck fractures, and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buehm for MXM
(Division Sign-Off)
Division of General. Restorative. and Neurological Devices
510(k) Number K061168
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