(50 days)
The Foundation® Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of 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. It is intended to be used in a cementless mode.
The Foundation® Porous Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads.
The Foundation® Porous Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads.
This document is a 510(k) premarket notification for a medical device, the Foundation® Porous Hip Stem - Size 8mm. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a diagnostic AI study would.
The provided text describes a submission for a hip stem prosthesis, which is a physical implant, not a diagnostic AI device. Therefore, a study focused on typical AI performance metrics like sensitivity, specificity, or reader improvement is not relevant to this type of medical device submission.
Instead, the "Test Results" section states: "Testing on this device included finite element analysis." This indicates that the evaluations done for this device likely focused on:
- Biocompatibility: Ensuring the materials are safe for implantation in the human body.
- Mechanical Strength and Durability: Assessing how well the implant can withstand the stresses of walking, running, and other activities over time. Finite Element Analysis (FEA) is a common method for this.
- Sterility: Verifying that the device is free from harmful microorganisms.
- Design Validation and Verification: Ensuring the device meets its design specifications and performs as intended.
Without a detailed engineering report or design validation plan, specific acceptance criteria for a hip stem (e.g., minimum fatigue life cycles, maximum stress under load, acceptable wear rates) and the explicit results proving these are met cannot be extracted from this summary.
Therefore, I cannot fulfill the request as it pertains to AI-specific acceptance criteria and studies. The document describes a traditional medical device (hip implant) submission, not an AI/ML device.
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Summary of Safety and Effectiveness
Encore Orthopedics, Inc. Debbie De Los Santos 9800 Metric Blvd. Austin, TX 78758 (512) 834-6237
Trade Name: Foundation® Porous Hip Stem - Size 8mm
Common Name: Cementless hip stem
Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis per 21 CFR 888.3358
Description: The Foundation® Porous Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads.
The Foundation® Porous Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads.
Intended Use: The Foundation® Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of 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. It is intended to be used in a cementless mode.
Comparable Features to Predicate Device(s): The Foundation® Porous Hip Stem has the same geometry, is manufactured from the same material, and has the same indications as the predicate devices.
Test Results: Testing on this device included finite element analysis.
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Image /page/1/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 1993
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758
Re: K991226 Foundation Porous Coated Hip Stem - Size 8mm Trade Name: Regulatory Class: II Product Codes: LZO and LPH Dated: April 9, 1999 Received: April 12, 1999
Dear Ms. De Los Santos:
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. 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 (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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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 regulations.
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Page 2 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as described in your 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 labelinq 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
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): Device Name: _ Faradation Porsus Hip Stem - Size 8 m
Indications For Use:
Foundation® Porous Hip Stem Indications For Use
The indications for use of the Foundation® Porous 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. This stem is intended to be used in a cementless mode.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)_
Acolleto
(Division Sign-Off)
Division of General Restorative Devices K991226
510(k) Number
§ 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.