(49 days)
The Revelation™ 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 nomunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
The Revelation™ Porous Hip Stem is fabricated from wrought/forged or cast Ti-6A1-4V that conforms to ASTM F136 or F1108. respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads to provide a porous surface for enhanced fixation. The Revelation™ Porous Hip Stem is collarless and has a Morse type taper to receive modular heads.
This document is a 510(k) premarket notification for a medical device (Revelation™ Porous Hip Stem). It indicates that the device has been found substantially equivalent to a predicate device already on the market.
Crucially, this document does not describe acceptance criteria or a study that proves the device meets those criteria, in the way one would typically expect for an AI/software device submission.
Instead, it's a notification about a physical orthopedic implant. For such devices, "acceptance criteria" and "studies" usually refer to mechanical testing (fatigue strength, torsional strength, etc.), biocompatibility testing, and potentially limited clinical follow-up for specific features if new. However, the provided text does not contain any of this information.
Therefore, I cannot fulfill your request as the information regarding acceptance criteria and performance studies for the Revelation™ Porous Hip Stem is not present in the provided text. The document is primarily an FDA clearance letter and a summary of the device's characteristics and intended use, asserting substantial equivalence to existing devices rather than detailing specific performance studies against acceptance criteria.
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K9940 Fr
JAN 2 0 2000
Summary of Safety and Effectiveness
Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, TX 78758 (512) 834-6237
Revelation™ Porous Hip Stem Trade Name:
Cementless hip stem Common Name:
Classification Name: Hip joint metal polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR 888.3358
The Revelation™ Porous Hip Stem is fabricated from wrought/forged or cast Ti-Description: 6A1-4V that conforms to ASTM F136 or F1108. respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads to provide a porous surface for enhanced fixation.
The Revelation™ Porous Hip Stem is collarless and has a Morse type taper to receive modular heads.
Intended Use: The Revelation™ 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 nomunion, 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 Revelation™ Porous Hip Stem has the same geomety, is manufactured from the same material, and has the same indications as the predicate devices.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a caduceus-like design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 0 2000
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopaedics Incorporated 9800 Metric Boulevard Austin, Texas 78758
Re: K994070
Trade Name: Revelation Porous Hip Stem (Size 8) Regulatory Class: II Product Code: LPH, MBL Dated: December 20, 1999 Received: December 21, 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 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 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 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 obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark McMullen
James E. Dillard, III Acting 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): | K994070 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications For Use:
Revelation™ Porous Hip Stem Indications For Use
The indications for use of the Revelation™ 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Modh M. Milkersen
$10(k) Number
§ 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.