(28 days)
The PLUS Cancellous Bone Screws are intended as a bone fixation device for a variety of surgical applications, such as fixation of press-fit acetabular cups in total hip arthroplasty or acetabular revisions, tibial components in total knee arthroplasty of knee revisions, and fixation of small and long bone fractures.
WARNING: These cancellous bone screws are not intended for spinal fixation.
The PLUS cancellous bone screws are presently available, non-sterile, as part of complete instrument and implant sets for the following predicate devices manufactured by PLUS: BOFOR® Revision Cup - K993874 – S/E/ 6/5/00 EPF®-PLUS Acetabular Cup - K994146 – S/E 12/11/00 These identical cancellous bone screws are now available, sterile, packaged individually in triple peel pouches (sterilized by Gamma irradiation). They are manufactured from Ti-6Al-4V ELI according to ASTM F136-98. They have a thread diameter of 6.5 mm and come in 10 lengths in 5 mm increments ranging from 15 mm to 60 mm. They have a standard 3.5 mm hexagonal screw head.
The provided text is a 510(k) Summary and related FDA correspondence for a medical device called "PLUS Cancellous Bone Screws." This document outlines the device's description, indications for use, and a comparison to predicate devices, focusing on regulatory equivalence for a modification (sterile presentation) of an already available device.
It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for an AI/algorithm-based device.
The document is purely for regulatory approval of a modified physical medical device (bone screws) and demonstrates substantial equivalence to existing devices through comparison of design, materials, and intended use. Performance is implicitly covered by the established safety and effectiveness of the predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance as the provided text does not contain this information for an AI/algorithm-based device.
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SPECIAL 510(K) DEVICE MODIFICATION PLUS Cancellous Bone Screws June 1, 2001
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| 510(k) Summary of Safety and Effectiveness[in accordance with SMDA of 1990, 21 CFR 807.92(c)] | |
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| Contact: | Mr. Hartmut Loch, RACDirector, Regulatory AffairsPLUS ORTHOPEDICS6055 Lusk Blvd.San Diego, CA 92121-2700Tel: 858.550.3800 x 2506 |
| EstablishmentRegistration #: | 2086141 |
| Classification:Regulation #:Device Class:Classification Panel:Product Code: | 21 CFR 888.3040Class II87 Orthopaedic Devices PanelHWC |
| Trade Name: | PLUS Cancellous Bone Screws |
| Common Name: | Bone Screws |
| Classification Name: | Screw, Fixation, Bone |
| Description& Modificationof Device: | The PLUS cancellous bone screws are presently available, non-sterile, as partof complete instrument and implant sets for the following predicate devicesmanufactured by PLUS:BOFOR® Revision Cup - K993874 – S/E/ 6/5/00EPF®-PLUS Acetabular Cup - K994146 – S/E 12/11/00These identical cancellous bone screws are now available, sterile, packagedindividually in triple peel pouches (sterilized by Gamma irradiation). They aremanufactured from Ti-6Al-4V ELI according to ASTM F136-98. They have athread diameter of 6.5 mm and come in 10 lengths in 5 mm incrementsranging from 15 mm to 60 mm. They have a standard 3.5 mm hexagonalscrew head.WARNING: These cancellous bone screws arenot intended for spinal fixation. |
| Indications: | The PLUS Cancellous Bone Screws are intended as a bone fixation device fora variety of surgical applications, such as fixation of press-fit acetabular cupsin total hip arthroplasty or acetabular revisions, tibial components in total kneearthroplasty of knee revisions, and fixation of small and long bone fractures. |
| Contraindications: | Contraindications include acute or chronic infections (local or systemic),serious lesions of muscles, nerves or blood vessels, bony defects or poorbone quality, any concurrent disease, which might interfere with the function ofthe cancellous bone screws, and the use for spinal fixation. |
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JUL - 2 2001
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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2001
Mr. Hartmut Loch, RAC Director, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121-2700
Re: K011719
Trade Name: PLUS Cancellous Bone Screws Regulation Number: 888.3040 Regulatory Class: II Product Code: HWC Dated: June 1, 2001 Received: June 4, 2001
Dear Mr. Loch:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have roviewed four betermined 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.
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, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific dairy vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This areguestions on the promotion and advertising of your device, (201) 594-4657. Traditionally, for quest on on 101 please note the regulation
please contact the Office of Compliance at (301) 594-4639. Also, please of Complex of 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 monthanon on your responsibility the number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
MMMMahurura
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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SPECIAL 510(K) DEVICE MODIFICATION PLUS Cancellous Bone Screws June 1, 2001
Page 1 1
510(k) Number: K011719
Device Name(s):
PLUS Cancellous Bone Screws
Indications for Use:
The PLUS Cancellous Bone Screws are intended as a bone fixation device for a variety of surgical applications, such as fixation of press-fit acetabular cups in total hip arthroplasty or acetabular revisions, tibial components in total knee arthroplasty of knee revisions, and fixation of small and long bone fractures.
WARNING: These cancellous bone screws are not intended for spinal fixation.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Дмитриенок
K01719 60 см
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number KO11719
X Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional format 1-2-96)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.