(286 days)
The BICON-PLUS Acetabular Components are intended for use in primary and revision total hip arthroplasty where the acetabular socket needs restructuring.
The BICON-PLUS Acetabular Components consists of threaded double cone made out of titanium with a polyethylene insert. Since the double cone corresponds very closely to the anatomical form of the acetabulum, the degree of bone resection in the region of the acetabulum base can be reduced. Two new titanium shells are available: The BICON-PLUS STANDARD cup and the BICON-PLUS POROSE cup. The size, thickness and height of the teeth have been adapted to the size of the cup. In addition to the standard insert, the new hooded version offers an increased support against luxation without compromising the range of motion. The titanium shells come in a range of nine standard sizes (sizes 1-9) and two special sizes (sizes O and 01). The PE inserts come in a range of sizes to match the shells to accommodate three ball head diameters (22mm, 28mm, and 32mm).
The provided text describes a 510(k) submission for the BICON-PLUS Acetabular Components, which are hip prostheses. This device is a physical medical implant, not an AI/ML-driven device or software. Therefore, the questions regarding acceptance criteria, study details, ground truth, and human reader performance are not applicable in the context of this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (OMNIFIT Threaded Acetabular Cup, K-883921). The key performance data mentioned is "Biomechanical Testing," with the statement that "All test results are sufficient for in vivo loading." However, specific acceptance criteria or detailed results of these biomechanical tests are not provided in this document.
To answer your request, I would need information related to an AI/ML-driven device or study.
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510(k) Summary of Safety and Effectiveness
(revised March 30, 2000) submitted by Hartmut Loch, C.E.O. PLUS ORTHOPEDICS 3550 General Atomics Ct., Bldg. 15-100 San Diego, CA 92121
BICON-PLUS Acetabular Components Trade name:
Common name: Acetabular Cup System
Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented Classification 21 CFR 888.3358 (87 LPH) name:
OMNIFIT Threaded Acetabular Cup, K-883921, S/E 10/13/88 Equivalence:
- The BICON-PLUS Acetabular Components consists of threaded double Characteristics: cone made out of titanium with a polyethylene insert. Since the double cone corresponds very closely to the anatomical form of the acetabulum, the degree of bone resection in the region of the acetabulum base can be reduced. Two new titanium shells are available: The BICON-PLUS STANDARD cup and the BICON-PLUS POROSE cup. The size, thickness and height of the teeth have been adapted to the size of the cup. In addition to the standard insert, the new hooded version offers an increased support against luxation without compromising the range of motion. The titanium shells come in a range of nine standard sizes (sizes 1-9) and two special sizes (sizes O and 01). The PE inserts come in a range of sizes to match the shells to accommodate three ball head diameters (22mm, 28mm, and 32mm).
- Indications: The BICON-PLUS Acetabular Components are intended for use in primary and revision total hip arthroplasty where the acetabular socket needs restructuring.
- Contraindications: Contraindications include acute or chronic infections (local or systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
Biomechanical Testing has been provided. Performance data: All test results are sufficient for in vivo loading.
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Public Health Service
6 2000 APR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics Building 15-100 3550 General Atomics Court San Diego, California 92121-1122
Re: K992154
Trade Name: Bicon-Plus Acetabular Components Regulatory Class: II Product Code: LPH Dated: January 13, 2000 Received: January 14, 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 controls 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,
Dmna R. Vochner
(n 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
510(k) Number (if known): K992154
Device Name: BICON-PLUS Acetabular Components
Indications for Use:
The BICON-PLUS Acetabular Components are intended for use in primary and revision total hip arthroplasty where the acetabular socket needs restructuring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danne R. Vochner.
(Division Sign-Off) Division or General Restorative Devices 510(k) Number_k992 154
2 -02 Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use $\mu_o$
(Optional Format 1-2-96)
§ 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.