(203 days)
The BOFOR Revision Cup is intended to be used to replace the acetabulum in revision hip arthroplasty.
The BOFOR Revision Cup consists of a titanium shell (Ti 6Al 4V) and an UHMWPE insert with a pure titanium cover shell. The BOFOR cup is asymmetrical and elongated, giving it a slightly "bean-shaped" design. This bean shape gives better three-point anchorage and provides better protection for the posterior column of the acetabulum. Other features of the BOFOR cup include a decentralized acetabulum inlay, cancellous bone screw anchorage, external fixation ribs, and a cranial keel, which acts as an adjuvant support column. The BOFOR cup comes in six sizes with compatible PE inserts in three sizes.
This document is a 510(k) summary for the BOFOR Revision Cup, a medical device intended for revision hip arthroplasty. The provided text primarily establishes substantial equivalence to predicate devices and outlines the device's characteristics, indications, and contraindications. It does not contain the detailed information requested regarding specific acceptance criteria, a study demonstrating performance against those criteria, or the methodology of such a study (sample size, ground truth, expert qualifications, etc.).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document mentions "Biomechanical Testing has been provided. All test results are sufficient for in vivo loading," but it does not elaborate on what these tests were, what their acceptance criteria were, or the performance metrics achieved.
To answer your request, a document detailing the specific performance studies (e.g., mechanical testing protocols, fatigue testing, wear resistance tests) and their results would be necessary.
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510(k) Summary of Safety and Effectiveness
November 12, 1999
Hartmut Loch, C.E.O. PLUS Orthopedics San Diego, CA
- Trade name: BOFOR Revision Cup
Cementless Acetabular Cup Common name:
Prosthesis, hip, metal/ceramic/polymer, semi-constrained cemented or Classification nonporous uncemented 21 CFR 888.3353 (87 LZO) name:
Howmedica Osteolock Acetabular Shell System (K971854, SE date Equivalence: 07-30-97) and Howmedica Osteolock Acetabular Cup (K981201, SE date 05-29-98).
The BOFOR Revision Cup consists of a titanium shell (Ti 6Al 4V) and Characteristics: an UHMWPE insert with a pure titanium cover shell. The BOFOR cup is asymmetrical and elongated, giving it a slightly "bean-shaped" This bean shape gives better three-point anchorage and design. provides better protection for the posterior column of the acetabulum. Other features of the BOFOR cup include a decentralized acetabulum inlay, cancellous bone screw anchorage, external fixation ribs, and a cranial keel, which acts as an adjuvant support column. The BOFOR cup comes in six sizes with compatible PE inserts in three sizes.
- Indications: The BOFOR Revision Cup is intended to be used to replace the acetabulum in revision hip arthroplasty.
- (local Contraindications include acute or chronic infections Contraindications: 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; retropatellar degenerative arthritis; extension contractures over 100 .
- Biomechanical Testing has been provided. Performance data: All test results are sufficient for in vivo loading.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2000
Mr. Hartmut Loch Chief Executive Officer PLUS Orthopedics 3550 General Atomics Court Bldg. 15-100 San Diego, California 92121-1122
Re: K993874 Trade Name: BOFOR Revision Cup Regulatory Class: II Product Code: LZO Dated: March 30, 2000 Received: March 31, 2000
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 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 - Mr. Hartmut Loch
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,
Dvina R. Lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification 510(k) BOFOR Revision Cup November 12, 1999
Page 1 of 1
510(k) Number (if known): K993874
Device Name: BOFOR Revision Cup
Indications for Use:
The BOFOR Revision Cup is intended to be used to replace the acetabulum in revision hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Durne R. Lochner
(Division St
D
5. K993874
Prescription Use
(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.