(58 days)
This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis.
This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.
The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.
The purpose of this premarket notification is to describe a modification to the Precision® Osteolock Femoral Stems with Hydroxyapatite Coating (previously determined substantially equivalent via 510(k) K912395). It is the intention of Howmedica Osteonics to change the hydroxyapatite coating on these femoral stems from the Low Pressure Plasma Spray (LPPS) HA coating described in K912395 to Howmedica Osteonics Pure-Fix™ HA coating. The Pure-Fix™ HA coating was originally determined substantially equivalent on the Osteonics® Omnifit® EPF Femoral Prosthesis in premarket notification K896047. This coating has been cleared for marketing on several other Osteonics® hip prostheses.
This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.
The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.
The provided text is a 510(k) summary for the Precision® Osteolock Femoral Stems with Pure-Fix™ HA Coating, indicating its substantial equivalence to a previously cleared device. It describes the device, its intended use, and its classification. However, it does not contain information about acceptance criteria, device performance studies, or details specified in your request (like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).
This type of submission focuses on demonstrating substantial equivalence to a predicate device, often relying on existing data and regulatory clearances for the components (in this case, the Pure-Fix™ HA coating) and the overall device design. It typically does not include new clinical study results or detailed performance data as would be expected for a novel device requiring extensive performance testing against predefined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.
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K99 2025
AUG 13 1999
510(k) Summary
Proprietary Name:
Common Name:
Classification Name and Reference:
Proposed Requlatory Class:
Device Product Code:
For information contact:
Precision® Osteolock Femoral Stems with Pure-Fix™ HA Coating
Press-Fit Titanium Femoral Stem
Prosthesis. Hip. Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate
Class II
MEH
Marybeth Naughton Requlatory Affairs Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401 Telephone: (201) 934-4376 (201) 934-4368 Fax: Date Summary Prepared: 5-21-99
The purpose of this premarket notification is to describe a modification to the Precision® Osteolock Femoral Stems with Hydroxyapatite Coating (previously determined substantially equivalent via 510(k) K912395). It is the intention of Howmedica Osteonics to change the hydroxyapatite coating on these femoral stems from the Low Pressure Plasma Spray (LPPS) HA coating described in K912395 to Howmedica Osteonics Pure-Fix™ HA coating. The Pure-Fix™ HA coating was originally determined substantially equivalent on the Osteonics® Omnifit® EPF Femoral Prosthesis in premarket notification K896047. This coating has been cleared for marketing on several other Osteonics® hip prostheses.
There is no change in intended use for the Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating. This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis.
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This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.
The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1-3 1999
Ms. Marybeth Naughton Regulatory Affairs Howmedica Osteonics, Corp. 59 Route 17 Allendale, New Jersey 07401-1677
Re: K992025
Trade Name: Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating Regulatory Class: II Product Code: MEH Dated: June 15, 1999 Received: June 16, 1999
Dear Ms. Naughton:
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 control provisions of the Act. The general control 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.
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.
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Page 2 -- Ms. Marybeth Naughton
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,
Cail M. Wilson, Ph.D., M.D.
V 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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Indications for Use
510(k) Number (if known):
Precision® Osteolock Femoral Stems with Pure-Fix™ HA Coating Device Name:
Indications for Use:
This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis.
This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.
The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
\begin{tabular}{ll}
\hline
& \
(Per 21 CFR 801.109) & \
\end{tabular}
OR
Over-The-Counter Use
\begin{tabular}{ll}
\hline
(Division Sign-Off) &
Division of General Restorative Devices &
510(k) Number & K992025
\end{tabular}
(Optional Format 1-2-96)
§ 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.