(60 days)
Not Found
No
The summary describes a bone cement and its physical properties, with no mention of AI or ML.
Yes
The device is a bone cement used for the fixation of prostheses to living bone, which is a therapeutic intervention.
No
This device is a bone cement used for fixation of prostheses, not for diagnosing conditions.
No
The device description clearly describes a physical bone cement product, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of prostheses to living bone". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bone cement" used for physical fixation.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of 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. This bone cement does not fit that description.
N/A
Intended Use / Indications for Use
Simplex P SpeedSet with Tobramycin bone cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
MBB
Device Description
Simplex P SpeedSet with Tobramycin Bone Cement is a radiopaque bone cement premixed with antibiotic capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 1-pack dispensers, with each individual pack containing one powder pouch of 41.1 g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex P SpeedSet with Tobramycin Bone Cement is approximately 5.36 minutes, with a dough time of 2 pouristian and a setting time of 9.6 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
living bone
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K063857'. The characters are written in a clear, sans-serif font, and they appear to be handwritten. The sequence likely represents an identification code or a serial number.
510(k) Summary of Safety and Effectiveness Simplex™ P SpeedSet Bone Cement with Tobramycin
FEB 2 6 2007
| Proprietary Name: | Simplex™ P SpeedSet with Tobramycin Bone Cement |
|---|---|
| Common Name: | Antibiotic PMMA Bone Cement |
| Classification Name and Reference | Polymethylmethacrylate (PMMA) bone cement |
| 21 CFR §888.3027 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 MBB - Polymethylmethacrylate (PMMA) bone cement. |
| Device Manufacturer: | Howmedica International S. de R.L. |
| Raheen Business Park, Limerick, Ireland | |
| For Information contact: | Tiffani Rogers |
| Regulatory Affairs Specialist | |
| Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07432 | |
| Phone: (201) 831-5612 | |
| Fax: (201) 831-6038 | |
| E-Mail: Tiffani.Rogers@stryker.com | |
| Date Summary Prepared: | February 15, 2007 |
Device Description
116
Simplex P SpeedSet with Tobramycin Bone Cement is a radiopaque bone cement premixed with antibiotic capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 1-pack dispensers, with each individual pack containing one powder pouch of 41.1 g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex P SpeedSet with Tobramycin Bone Cement is approximately 5.36 minutes, with a dough time of 2 pouristian and a setting time of 9.6 minutes.
P.1/2
1
Indications For Use:
Simplex P SpeedSet with Tobramycin bone cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.
Substantial Equivalence:
The Simplex P SpeedSet with Tobramycin bone cement has the same indications, same liquid monomer and similar powder component as Simplex P with Tobramcyin bone cement (K014199 cleared 06 May 2003). The handling properties of Simplex P SpeedSet with Tobramycin are the same as those with Simplex P SpeedSet (K053198 cleared 26 January 2006). Howmedica Osteonics Corp. believes the Simplex P SpeedSet with Tobramycin bone cement to be substantially equivalent to Simplex P with Tobramycin and Simplex P SpeedSet bone cements.
2
Image /page/2/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2007
Stryker Orthopaedics % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K063857
Trade/Device Name: Simplex® P SpeedSet with Tobramycin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: MBB Dated: December 22, 2006 Received: December 28, 2006
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket 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 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
3
Page 2 - Ms. Tiffany Rogers
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 (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications
Simplex P SpeedSet with Tobramycin Bone Cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.
Prescription Use X (Per 21 CFR 801.109)
OR Over-the-Counter Use
(Please Do Not Write Below This Line - Continue on Another Page if Needed)
enbare buedun
(Division Sign-Off) Division of General, Restorative, and Neurological Device
510(k) Number