(768 days)
N17004
Not Found
No
The device description details a chemical composition and delivery system for bone cement, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a bone cement used for fixation of prostheses, which is a supportive material rather than a device that directly treats or prevents a disease or condition itself.
No
The device, GENERATION 4 Bone Cement, is indicated for the fixation of prostheses to living bone, which is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it is a "self-curing agent comprised of two sterile components (liquid and powder)" which are physical substances, not software.
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 in orthopedic musculoskeletal surgical procedures." This describes a surgical implant/material used directly on the patient's body during a procedure.
- Device Description: The device is a "self-curing agent comprised of two sterile components (liquid and powder) mixed... forming polymethyl methacrylate (PMMA) bone cement." This is a material used in surgery, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to diagnose, monitor, or screen for diseases or conditions by examining samples.
Therefore, the GENERATION 4 Bone Cement is a surgical material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GENERATION 4 Bone Cement is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty procedures.
GENERATION 4 Bone Cement is intended for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, 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
GENERATION 4 Bone Cement System is a self-curing agent comprised of two sterile components (liquid and powder) mixed in the Vacuum Pac delivery system forming polymethyl methacrylate (PMMA) bone cement.
The liquid component (monomer) is comprised of the following:
Methyl methacrylate monomer 98%
N,N-dimethyl-p-toluidine 2%
Hydroquinone 60ppm
Methyl methacrylate monomer is the primary constituent of the liquid component. In much smaller quantities are the accelerator, N,N-dimethyl-p-toluidine, and the stabilzer, hydroquinone, both of which are typical constituents in PMMA bone cement.
The powder component is comprised of the following: Methyl methacrylate - stryrene copolymer 90 % 10% Barium sulfate, U.S.P.
Methyl methacrylate – styrene copolymer is the primary constituent of the powder component. Barium sulfate is added as a radiopacifier. Both are typical constituents of PMMA bone cement.
When the powder and liquid components are mixed, the accelerator speeds the generation of free radicals and the stabilizer in the liquid reacts with many of the early free radicals, but is soon consumed. Free radicals can then initiate formation of polymer chains.
Polymerization proceeds slowly over the first few minutes. Polymer chains at the surface of the powder beads mingle with monomer and newly formed polymer chains, while smaller beads may dissolve completely. The cement temperature rises as set-time of the cement approaches. Polymerization is essentially complete and the bone cement hard within 10 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
living bone in orthopedic musculoskeletal
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)
N17004
Reference Device(s)
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
DEC 1 9 2001
K 993836
page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Contact Person: Mary L. Verstynen
Product Code: LOD
Device Name: GENERATION 4 Bone Cement
Indications for Use:
GENERATION 4 Bone Cement is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty procedures.
Device Description:
GENERATION 4 Bone Cement System is a self-curing agent comprised of two sterile components (liquid and powder) mixed in the Vacuum Pac delivery system forming polymethyl methacrylate (PMMA) bone cement.
The liquid component (monomer) is comprised of the following:
| Methyl methacrylate monomer | 98% |
|---|---|
| N,N-dimethyl-p-toluidine | 2% |
| Hydroquinone | 60ppm |
Methyl methacrylate monomer is the primary constituent of the liquid component. In much smaller quantities are the accelerator, N,N-dimethyl-p-toluidine, and the stabilzer, hydroquinone, both of which are typical constituents in PMMA bone cement.
Formula:
CH3
CH2=C-COOCH3 Methyl methacrylate monomer
The powder component is comprised of the following: Methyl methacrylate - stryrene copolymer 90 % 10% Barium sulfate, U.S.P.
1
page 2 of 2
Methyl methacrylate -- styrene copolymer is the primary constituent of the powder component. Barium sulfate is added as a radiopacifier. Both are typical constituents of PMMA bone cement.
Formula:
`CH3
- CH2=C-CH2-CH-C-
|
COOCH3 C6C5 COOCH3 n`
Methyl methacrylate - styrene copolymer
When the powder and liquid components are mixed, the accelerator speeds the generation of free radicals and the stabilizer in the liquid reacts with many of the early free radicals, but is soon consumed. Free radicals can then initiate formation of polymer chains.
Polymerization proceeds slowly over the first few minutes. Polymer chains at the surface of the powder beads mingle with monomer and newly formed polymer chains, while smaller beads may dissolve completely. The cement temperature rises as set-time of the cement approaches. Polymerization is essentially complete and the bone cement hard within 10 minutes.
| Potential Risks: | |
|---|---|
| Cardiac arrest | Transitory fall in blood pressure |
| Myocardial infarction | Thromobophlebitis |
| Pulmonary embolism | Hemorrhage and hematoma |
| Cerebrovascular accident | Loosening or displacement of prosthesis |
| Sudden death | Superficial or wound infection |
| Trochanteric bursitis | Short-term cardiac conduction irregularities |
| Heterotopic new bone formation | Trochanteric separation |
| Pyrexia (due to allergy) | Hematuria |
| Dysuria | Bladder fistula |
| Local neuropathy | Local vascular erosion and occlusion |
| Intestinal obstruction due to extrusion of the bone cement beyond the region of its |
Substantial Equivalence: The GENERATION 4 Bone Cement was found to be substantially equivalent to the following predicate bone cement in terms of indications for use, intended use, technological characteristics and material.
intended use
Predicate device: Surgical Simplex P Radiopaque Bone Cement Howmedica Corporation PMA Number: N17004
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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2001
Ms. Mary L. Verstynen Manager of Clinical Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581
Re: K993836
Trade Name: Generation 4® Bone Cement Regulation Number: 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: II Product Code: LOD Dated: October 2, 2001 Received: October 3, 2001
Dear Ms. Verstynen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your wed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are basical to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of Prial 2011-12-11 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 r ou may, alereleve, mains of the Act include requirements for annual registration, listing of general controls proficituring 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 rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to data arrant 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 r 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 or any I 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. Mary L. Verstynen
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. 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,
S. Gail M. Witte, Ph.D., M.D.
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
Page _ of _
510(k) NUMBER (iF KNOWN): _ K 9 9 3 8 3 6
DEVICE NAME: GENERATION 4 Bone Cement
INDICATIONS FOR USE:
GENERATION 4 Bone Cement is intended for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number ≤ 9938 3 C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Per 21 CFR 801.109)
OR
Over- The- Counter- No (Optional Format 1-2-96