GENERATION 4 BONE CEMENT

K993836 · Biomet, Inc. · LOD · Dec 19, 2001 · Orthopedic

Device Facts

• Record ID: K993836
• Device Name: GENERATION 4 BONE CEMENT
• Applicant: Biomet, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Dec 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

GENERATION 4 Bone Cement is a self-curing, two-component (liquid monomer and powder) system used for orthopedic prosthesis fixation. The liquid contains methyl methacrylate monomer, N,N-dimethyl-p-toluidine (accelerator), and hydroquinone (stabilizer). The powder contains methyl methacrylate-styrene copolymer and barium sulfate (radiopacifier). Components are mixed in a Vacuum Pac delivery system to initiate polymerization. The resulting PMMA bone cement hardens within 10 minutes. Used by surgeons in clinical/OR settings to secure implants to bone. Benefits include structural stabilization of prostheses in joint replacement or revision procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-curing PMMA bone cement. Liquid: 98% methyl methacrylate monomer, 2% N,N-dimethyl-p-toluidine, 60ppm hydroquinone. Powder: methyl methacrylate-styrene copolymer, barium sulfate (radiopacifier). Delivery: Vacuum Pac system. Polymerization: free-radical initiation, exothermic reaction, set time < 10 minutes.

Indications for Use

Indicated for fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for patients with osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma, or those requiring revision of previous arthroplasty.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Surgical Simplex P Radiopaque Bone Cement (N17004)

Submission Summary (Full Text)

{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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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