(77 days)
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. This stem is to be press-fit.
The Linear stems without HA coating were cleared for commercial distribution on K974294 and K991325; the Foundation stem on K973302 and K991226; and the The only difference between the devices cleared in the Revelation on K973685. aforementioned submissions and this is the addition of hydroxyapatite to the porous The porous coating is plasma sprayed with coated regions of the proximal bodies. hydroxyapatite (HA).
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for HA Coated Hip Stems. The document is a 510(k) summary and FDA letter, which primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing performance studies and specific acceptance criteria.
The information provided only discusses:
- The submitter's name and address
- Device name, common name, and classification name
- Legally marketed predicate devices
- Subject device description and intended use
- Technological characteristics and basis for substantial equivalence to predicate devices.
- The FDA's decision to clear the device for market based on substantial equivalence.
Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving the device meets those criteria from the provided text.
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FEB 4 2000
510(k) Summary of Safety and Effectiveness
| (1) Submitter's name: | Encore Orthopedics, Inc. |
|---|---|
| Submitter's address: | 9800 Metric Blvd, Austin, TX 78758 |
| Submitter's telephone number: | (512) 834-6237 |
| Contact person: | Debbie De Los Santos |
| Date summary prepared: | November 18, 1998 |
| (2) Trade or proprietary device name: | HA Coated Hip Stems |
| Common or usual name: | Cementless hip stem |
| Classification name: | Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis |
| (3) Legally marketed predicate device: | MCS - HA Porous Coated Total Hip (Exactech) Natural-Hip Porous Stem with HA (Intermedics) |
-
(4) Subiect device description:
The Linear stems without HA coating were cleared for commercial distribution on K974294 and K991325; the Foundation stem on K973302 and K991226; and the The only difference between the devices cleared in the Revelation on K973685. aforementioned submissions and this is the addition of hydroxyapatite to the porous The porous coating is plasma sprayed with coated regions of the proximal bodies. hydroxyapatite (HA). -
(ર) Subject device intended 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. This stem is to be press-fit. -
Technological characteristics: (6) The HA Coated Stems have the same technological characteristics (i.e., design and material) when compared to the predicate devices
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(7) Basis for substantial equivalence: Features comparable to predicate devices include HA coating, Ti-6Al-4V substrate, straight stem, symmetric, no collar, narrow slightly taper stem in lateral view, and modular heads.
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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 features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB | 4 2000
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Medical Corporation 9800 Metric Boulevard Austin, Texas 78758
Re: K993943
Trade Name: Linear™ Porous Coated Hip Stem with HA Foundation® Porous Coated Hip Stem with HA Revelation™ Porous Coated Hip Stem with HA Regulatory Class: II Product Code: MEH Dated: November 18, 1999 Received: November 19, 1999
Dear Ms. 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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil K. Ogden
James E. Dillard II 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): ____________________________________________________________________________________________________________________________________________________
Device Name: HA Coated Hip Stems
Indications For Use:
HA Coated Hip Stems 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. This stem is to be pressfit.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | DRO for SED |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K993943 |
| Prescription Use (Per 21 CFR 801.109) | Yes |
|---|---|
| --------------------------------------- | ----- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | No |
|---|---|
| ----------------------------------------------- | ---- |
§ 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.