(193 days)
No
The 510(k) summary describes a total hip replacement prosthesis and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the materials and compatibility with existing cleared stems.
Yes.
The device is a total hip replacement prosthesis intended to treat degenerative joint disease, rheumatoid arthritis, correct functional deformity, and treat fractures, which are therapeutic interventions.
No
Explanation: The device is described as a total hip replacement prosthesis for treating various joint diseases and fractures, not for diagnosing conditions.
No
The device description clearly states it is a "Zirconia ceramic heads for use with Foundation® Forged... and Porous Stems... and the Encore® Vitality™ Stem... and the SL and SLR PLUS... Hip Stems". This describes physical components of a hip replacement prosthesis, not software.
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 "total hip replacement prosthesis" and "Zirconia ceramic heads for use with... Hip Stems." This is an implantable medical device used within the body, not for testing specimens outside the body.
- Intended Use: The intended use describes treating conditions like degenerative joint disease, rheumatoid arthritis, and fractures. These are conditions treated by replacing a joint, not by analyzing bodily fluids or tissues.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
Product codes
LZO
Device Description
Zirconia ceramic heads for use with Foundation® Forged (K952191), Textured (K935263) and Porous Stems (K952297), the Encore® Vitality™ Stem (K962560) and the SL and SLR PLUS (K932481) Hip Stems which have been cleared for commercial distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K952191, K935263, K952297, K962560, K932481
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
K96 5002
Summary of Safety and Effectiveness
JUN 27 1997
Encore Orthopedics™, Inc. 8900 Shoal Creek Bldg. 300 Austin, TX 78757 512-795-8696 Ashley M. Bock
Trade Name: Zirconia ceramic heads for use with Encore® Vitality™, SL and SLR PLUS, and Foundation™ Forged, Textured and Porous Stems.
Common Name: Ceramic femoral head
Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented prosthesis per 21 CFR 888.3353. (LZO).
Description: Zirconia ceramic heads for use with Foundation® Forged (K952191), Textured (K935263) and Porous Stems (K952297), the Encore® Vitality™ Stem (K962560) and the SL and SLR PLUS (K932481) Hip Stems which have been cleared for commercial distribution.
Indications for Use: The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
Comparable Features to Predicate Device(s): The Zirconia ceramic heads to be used with Foundation® Forged, Textured and Porous Stems, the Encore ® Vitality™ Stem and SL and SLR PLUS Hip Stems are equivalent in material, design and clinical indications to the zirconia heads also manufactured by Demarquest for Zimmer (K944601) , DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ashley M. Bock Requlatory Specialist Encore Orthopedics; Inc: 9800 Metric Boulevard Austin, Texas 78758
JUN 27 1997
Re : K965002 Zirconia Ceramic Femoral Heads for use with the Foundation Forged, Textured, and Porous Stems, the Encore Vitality Stem, and SL and SLR PLUS Hip Stems Regulatory Class: II Product Code: LZO Dated: April 15, 1997 Received: April 17, 1997
Dear Ms. Bock:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Zirconia Ceramic Femoral Heads for use with the Foundation Forged, Textured, and Porous Stems, the Encore Vitality Stem, and SL and SLR PLUS Hip Stems are to be used only with cobalt-chrome and Ti6Al4V alloy hip stems with the Cerasiv taper trunnions.
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.
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Page 2 - Ms. Ashley M. Bock
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
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Page 3 - Ms. Ashley M. Bock
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours, J
Marie Afchude, ms, PT
Image /page/3/Picture/4 description: The image shows a handwritten word, which appears to be "for". The writing is in a cursive style, with the letters connected. The image is in black and white, and the writing is clear and legible.
Celia M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K965002 |
|---|---|
| Device Name: | Encore Zirconia Femoral Heads |
Indications For Use:
Encore® Zirconia Heads Indications For Use
The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) rer. · "IVe Devic 1971981 (NUTIDET
Prescription Use (per 21 CFR 801. 109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)_