(156 days)
P960001/Supplement 3, P810020/Supplement 3
Not Found
No
The provided text describes a bone cement and its physical properties and intended use. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The description focuses solely on the material composition and handling characteristics of the cement.
Yes
The device is a bone cement used for the fixation of prostheses to living bone, which is a therapeutic intervention for various medical conditions.
No
This device is a bone cement used for fixing prostheses to bone during surgical procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a bone cement, which is a physical material (powder and liquid components), not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided text describes a bone cement used to fix prostheses to bone during surgical procedures. This is a material implanted into the body to provide structural support and fixation.
- Intended Use: The intended use clearly states it's for "fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures." This is a surgical application, not a diagnostic test performed on a sample outside the body.
Therefore, based on the description and intended use, SmartSet HV Bone Cement is a medical device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthitis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
Product codes
LOD
Device Description
SmartSet HV Bone Cement is a high viscosity bone cement which is equally suited for both digital and syringe use. It has a short dough time (approximately 1 minute), a setting time of 9 -11 mins and consequently a long working time. These handling characteristics make SmartSet HV Bone Cement ideally suited for use with modern cementing techniques and clinical applications. The subject device is for single use only and is available in either 20g or 40g single unit packs and 10 ×1 unit dispenser cartons. Each single unit (device) pack consists of a polymeric powder component and a monomeric liquid component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
living bone in orthopaedic musculoskeletal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic musculoskeletal surgical procedures
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
P960001/Supplement 3, P810020/Supplement 3
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 1 3 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| SPONSOR OF THIS 510(K): | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
P.O. Box 988
Warsaw, Indiana 46581-0988 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER: | DePuy International Ltd
Trading as DePuy CMW
Cornford Road
Blackpool, Lancashire
FY 4 4QQ, England |
| 510(K) CONTACT: | Janet Johnson, RAC
DePuy Orthopaedics, Inc.
Group Leader, Regulatory Submissions
(574) 371-4907; FAX (574) 371-4987
E-mail: jjohnso7@dpyus.jnj.com |
| TRADE NAME: | SmartSet HV Bone Cement |
| COMMON NAME: | PMMA Bone Cement |
| CLASSIFICATION: | PMMA Bone Cement: Class II per 21 CFR 888.302 |
| DEVICE CODE: | LOD |
| EQUIVALENT DEVICES: | DePuy 1 Bone Cement - P960001/Supplement 3
Palacos R40 Bone Cement - P810020/Supplement 3 |
DEVICE DESCRIPTION AND INTENDED USE:
SmartSet HV Bone Cement is a high viscosity bone cement which is equally suited for both digital and syringe use. It has a short dough time (approximately 1 minute), a setting time of 9 -11 mins and consequently a long working time. These handling characteristics make SmartSet HV Bone Cement ideally suited for use with modern cementing techniques and clinical applications. The subject device is for single use only and is available in either 20g or 40g single unit packs and 10 ×1 unit dispenser cartons. Each single unit (device) pack consists of a polymeric powder component and a monomeric liquid component.
SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
1
K 023012
BASIS OF SUBSTANTIAL EQUIVALENCE:
SmartSet HV Bone Cement has similar indications for use as other bone cements currently marketed in the United States. These predicate devices include:
-
- DePuy 1 Bone Cement
-
- Palacos R40 Bone Cement
All three bone cements are intended to be used for the fixation of artificial joints and prosthesis to host bone.
Based on similarities of design, materials, intended use, and testing performed, DePuy believes that the subject SmartSet HV Bone Cement is substantially equivalent to the above described FDA cleared devices currently on the market.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB 1 3 2003
Ms. Janet G. Johnson, RAC DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K023012
Trade Name: SmartSet HV Bone Cement Regulation Number: 21 CRF 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: January 3, 2003 Received: January 6, 2003
Dear Ms. Johnson:
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 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.
3
Page 2 -- Ms. Janet G. Johnson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Mulkeren
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
4
Indications for Use:
510(k) Number (if known)
Device Name: SmartSet HV Bone Cement
Indications for Use:
SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthitis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
Concurrence of CDRH, Office of Device Evaluation
for Mark n Mckeen
Division Sign-
Divisio: and Neurological Dev
KO 23012 710(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use