(212 days)
The INTRAPLANT Ceramic Head Prostheses is intended for use in total hip arthroplasty. 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 procedure where previous 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.
The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS® and SLR-PLUS® hip stems.
The INTRAPLANT Ceramic Head Prostheses are manufactured by METOXIT AG (alumina and zirconia). Both come with the standard taper cone 12/14 in six sizes, 28mm (S, M, L) and 32mm (S, M, L).
The provided text is a 510(k) summary for a medical device called INTRAPLANT Ceramic Head Prostheses. This document describes the device, its intended use, and substantial equivalence to previously marketed devices. It does not contain information about the acceptance criteria for a study, nor does it present a study proving the device meets specific performance criteria in the way typically required for AI/ML or diagnostic devices.
The relevant section, "Performance data," states only: "Biomechanical testing has been provided." This is a very high-level statement and does not include any specifics about:
- Specific acceptance criteria (e.g., minimum force, wear rates, fatigue life)
- The results of biomechanical testing against those criteria
- Sample sizes, data provenance, ground truth establishment, or expert involvement as would be relevant for software or diagnostic device studies.
Therefore, I cannot fulfill the request as it pertains to acceptance criteria and a study proving their fulfillment for the INTRAPLANT Ceramic Head Prostheses based solely on the provided text. The information requested (Table of acceptance criteria, sample sizes, experts, adjudication, MRMC, standalone, ground truth, training set information) is entirely absent from this 510(k) summary.
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AUG 27 1999
Premarket Notification 510(k) INTRAPLANT Ceramic Head Prostheses August 13, 1999
510(k) Summary of Safety and Effectiveness
August 13, 1999
INTRAPLANT Ceramic Head Prostheses Trade name:
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Ceramic femoral head Common name:
Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Classification Porous Uncemented Prosthesis, 21 CFR 888.3353 (87 LZO) name: -
Zirconia Ceramic Femoral Heads, Encore Orthopedics (K965002, SE Equivalence: 06/27/97), the S-ROM Zirconia Ceramic Femoral Head, Johnson & Johnson Professional (K980081, SE 04/09/98), the Biolox Alumina Ceramic Femoral Head, Smith & Nephew (K981847, SE 07/17/98). the Alumina C-Taper Head, Osteonics (K971409, SE 07/09/97).
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Characteristics: The INTRAPLANT Ceramic Head Prostheses are manufactured by METOXIT AG (alumina and zirconia). Both come with the standard taper cone 12/14 in six sizes, 28mm (S, M, L) and 32mm (S, M, L).
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The INTRAPLANT Ceramic Head Prostheses are intended for use in Indications: total hip arthroplasty. 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 procedure where previous 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. The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS® and SLR-PLUS® hip stems.
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Contraindications: Contraindications include acute or chronic infections (local or systemic) or a history of infection; severe muscular, neurological, or vascular deficiencies which compromise the affected extremity; bone defects or insufficient bone quality which may affect the stability of the implant; any concomitant illness which may compromise the function of the implant; severe obesity; allergy to the implant materials; subluxation of the femur against the eminentia; ligament instability; severe varus or valgus misalignment.
Performance data: Biomechanical testing has been provided.
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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 resembling three overlapping lines forming a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics 3550 General Atomics Court Building 15-100 San Diego, California 92121-1122
K990261 Re:
Trade Name: Intraplant Ceramic Head Prostheses Regulatory Class: II Product Code: LZO Dated: June 15, 1999 Received: June 17, 1999
Dear Mr. Loch:
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 – Mr. Hartmue Loch
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,
Thurell Hopkins
なら 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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Page 1 of 1
Premarket Notification 510(k) INTRAPLANT Ceramic Head Prostheses August 13, 1999
510(k) Number (if known): K99026/
Device Name: INTRAPLANT Ceramic Head Prostheses
Indications for Use:
The INTRAPLANT Ceramic Head Prostheses is intended for use in total hip arthroplasty. 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 procedure where previous 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.
The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS® and SLR-PLUS® hip stems.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Russell W. Hugon for J2p
(Division Sign-Off)
(Per 21 CFR 801.109)
Division of General Restorative Devices 510(k) Number
Prescription Use _ up (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(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.