(18 days)
No
The 510(k) summary describes a physical, bioabsorbable cement restrictor and makes no mention of AI, ML, image processing, or any software-based functionality.
No
The device is described as a "bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty." Its function is to restrict cement flow, not to treat a disease or condition.
No
Explanation: The device is a cement restrictor intended for intramedullary occlusion during cemented hip and shoulder arthroplasty, which is a therapeutic rather than diagnostic function. It is used to block or restrict, not to identify or assess a medical condition.
No
The device description clearly states it is a physical, bioabsorbable plug made of PolyActive®, intended for intramedullary occlusion. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "intramedullary occlusion during cemented hip and shoulder arthroplasty." This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a physical implantable device made of a bioabsorbable material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The BioBuck™ Cement Restrictor is a surgical implant used during a procedure.
N/A
Intended Use / Indications for Use
The BioBuck™ Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.
Product codes
LZN
Device Description
The BioBuck™ Cement Restrictor is a bioabsorbable version and modification of the Buck™ Cement Restrictor that was cleared for marketing by FDA on 27 June 1979 (K791125). The material for the BioBuck device is PolyActive®, a biocompatible copolyether. PolyActive is currently used to manufacture other cement restrictor devices (Shuttle Stop , K000587; SynPlug™ , K010840).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
K 0 2 3 6 8 0
page 1 of 1
510(k) Summary of Safety and Effectiveness BioBuck™ Cement Restrictor
| Submitted By: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 | NOV 1 9 2002 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------|
| Date: | October 31, 2002 | |
| Contact Person: | David Henley
Senior Clinical/Regulatory Affairs Specialist
Tel: (901) 399-6487
Fax: (901) 398-5146 | |
| Proprietary Name: | BioBuck™ Cement Restrictor | |
| Common Name: | Cement Restrictor | |
| Classification Name and Reference: | Cement Obturator | |
| Device Product Code and Panel Code: | Orthopedics/87/LZN | |
| Predicate Devices: | Buck™ Cement Restrictor (K791125)
Shuttle Stop® Cement Restrictor (K000587)
SynPlug™ Cement Restrictor (K010840) | |
Device Description:
The BioBuck™ Cement Restrictor is a bioabsorbable version and modification of the Buck™ Cement Restrictor that was cleared for marketing by FDA on 27 June 1979 (K791125). The material for the BioBuck device is PolyActive®, a biocompatible copolyether. PolyActive is currently used to manufacture other cement restrictor devices (Shuttle Stop , K000587; SynPlug™ , K010840).
Intended Use:
The BioBuck Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.
Technological Characteristics:
The principles of operation for the BioBuck Cement Restrictor are identical to the Buck Cement Restrictor, as well as the Shuttle Stop and SynPlug. All are cement plugs that are inserted in the intramedullary canal during implantation of a joint prosthesis to prevent the migration of bone cement. The design and material of the BioBuck device has the same technological characteristics as one or more of the predicate devices.
Substantial Equivalence Information:
The intended use of the BioBuck Cement Restrictor is identical to the predicate devices. The BioBuck device shape and design are very similar to the Buck predicate device, and the BioBuck device is manufactured from the identical material as the Shuttle Stop and SynPlug predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew Incorporated Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
NOV 1 9 2002
K023680 Re: Trade Name: BioBuck™ Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Cement Obturator Regulatory Class: II Product Code: LZN Dated: October 31, 2002 Received: November 1, 2002
Dear Mr. Henley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594- . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millerson
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
3
Indications for Use Statement BioBuck™ Cement Restrictor
510(k) Number (if known):
Device Name: BioBuck™ Cement Restrictor
Indications for Use:
The BioBuck™ Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milkerem
(Division Sign-Off) Division of General, Restorative and Nourological Devices
stock number K023680
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)