OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES

K012251 · Exactech, Inc. · JWH · Jul 31, 2001 · Orthopedic

Device Facts

• Record ID: K012251
• Device Name: OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
• Applicant: Exactech, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 31, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. CAUTION: For cemented use only in the USA.

Device Story

Optetrak Total Knee System Stem Extensions are orthopedic implants used in total knee replacement surgery. These extensions are designed to provide additional stability and fixation for the femoral or tibial components. They are manufactured from Titanium alloy (ASTM F-1472) and feature a Morse taper connection. The device is intended for use by orthopedic surgeons in a hospital or surgical center setting. The extensions are implanted during primary or revision knee arthroplasty to address bone stock deficiencies or to enhance component stability. The surgeon selects the appropriate length and diameter to match the patient's anatomy. The device is for cemented use only in the USA. By providing a range of sizes, the system allows for better customization to the patient's specific anatomical needs, potentially improving the longevity and stability of the knee reconstruction.

Clinical Evidence

No clinical data. Bench testing only. Analytical analysis demonstrated that stem extension strength is independent of length and diameter, supporting the conclusion that the additional sizes perform similarly to the existing, predicate Optetrak stem extensions.

Technological Characteristics

Material: Titanium alloy (ASTM F-1472). Design: Morse taper connection with flutes. Sterilization: Gamma radiation (Cobalt 60), 25-37 kGy, SAL 10^-6. Packaging: Vacuum-sealed high barrier bags (Nylon/EVOH/Polyethylene) and Tyvek pouches.

Indications for Use

Indicated for skeletally mature patients undergoing primary total knee replacement for osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degeneration, and for revision of failed reconstructions with sufficient bone stock and soft tissue integrity. Contraindicated in patients with active infection, insufficient bone stock or soft tissue integrity, mental/neuromuscular disorders preventing joint control, or conditions where weight/age/activity level risk extreme loads and early failure.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Optetrak Total Knee (K933610)
• Optetrak Total Knee (K954208)

Reference Devices

• Nexgen (Zimmer)
• Maxim (Biomet)
• Durcon Total Stabilizer (Howmedica)

Submission Summary (Full Text)

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KO12251

2320 NW 66TH COURT GAINESVILLE, FL 32653

352-377-1140 FAX [phone]

## JUL 3 1 2001

# Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes

# 510(k) Summary of Safety and Effectiveness Special 510(k)

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

| Phone: | (352) - 377 - 1140 |
|--------|--------------------|
| Fax: | (352) - 378 - 2617 |

FDA Establishment Number 1038671

Robert Paxson Contact: Director of Engineering & Development

Date:

June 22, 2001

Section 4 Page 1 of 4

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# Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes

# 510(k) Summary of Safety and Effectiveness Special 510(k)

### Classifications / Proprietary Names:

Classification Name:

Prosthesis, knee, patellofemorotibial, semi-contrained, cemented, polymer/metal polymer

Trade / Proprietary Model Names:

Optetrak Total Knee System Stem Extensions - Additional Sizes

JWH Product Code: 888.3560 C.F.R. Section:

II Device Class:

Classification Panel: Orthopedic

# Legally Marketed Devices for Substantial Equivalence Comparison:

| Model | Manufacturer | 510(k) Number |
|--------------------------------------------|----------------------|----------------------|
| Optetrak Total Knee<br>Optetrak Total Knee | Exactech<br>Exactech | #K933610<br>#K954208 |
| Nexgen | Zimmer | -------- |
| Maxim | Biomet | -------- |
| Durcon Total Stabilizer | Howmedica | -------- |

### Device Information:

### INDICATIONS

The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, marradals and organis id arthritis and/or post-traumatic degenerative problems. They ore also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

CAUTION: For cemented use only in the USA.

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## Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes

## 510(k) Summary of Safety and Effectiveness Special 510(k)

#### CONTRAINDICATIONS

The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

#### DEVICE DESCRIPTION

Like the original Optetrak stem extensions, the proposed Optetrak Straight Stem Extension additional sizes are composed of Titanium alloy (ASTM F-1472). The proposed stem extensions have the same Morse taper call out and flute that the existing stem extensions offer. The design incorporates the same design features as the predicate Optetrak stem extensions over new lengths and diameters to create a complete range of sizes for the surgeon. The proposed Straight Stem Extension Line Extensions are fully compatible with the existing Optetrak Tibial Trapezoid trays (#K933610) and the Constrained Condlyar Femoral Component and bushing (#K954208).

| Packaging Materials | |
|---------------------|---------------------------------------------------------------------|
| Material | Composition |
| Vacuum Bag | High Barrier – 3 Mil, 75 gauge<br>Nylon with EVOH 2.25 Polyethylene |
| Polymer Bags | 3 Mil Polyethylene |
| Inner/Outer Pouches | 48GAPET/.002LDPE |
| Pouch Seals | 1073B Uncoated Tyvek® |
| Box | Heavy weight cardboard |
| Outer Shrink-Wrap | Clear, Light-Weight Plastic |
| Shipping Cartons | Heavy-weight Corrugated Cardboard |

#### PACKAGING MATERIALS

#### STERILIZATION INFORMATION

Method: Gamma radiation (Cobalt 60 source) Dose: 25 - 37 kGy Sterility Assurance Level (SAL): 10-6

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# Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes

## 510(k) Summary of Safety and Effectiveness Special 510(k)

### PERFORMANCE DATA

The design assurance reviews for the proposed products did not indicate the need for additional testing since the parts were so comparable to the existing Exactech stem extensions and no new failure modes were identified.

According to analytical analysis the proposed stem extension components showed that the stem extension strength was independent of length and diameter. Therefore, the proposed stem extensions should have the similar clinical results to the existing Exactech straight stem extensions.

We conclude that the new Optetrak Stem Extensions are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products.

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JUL 3 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert Paxson Director of Engineering & Development Exactech. Inc. 2320 N.W. 66th Court Gainsville, Florida 32653

Re: K012251

Trade Name: Optetrak Total Knee System Regulatory Class: II Regulation Number: 888.3560 Product Code: JWH Dated: July 17, 2001 Received: July 18, 2001

Dear Dr. Paxson:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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### Page 2 - Mr. Robert Paxson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific darices), please contact the Office of Compliance at additionally 609110 for questions on the promotion and advertising of your device, (2017) 59 + 105 + 1 = 0 ffice of Compliance at [phone]. Also, please note the regulation predise ounder the Oriety of eference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

R.M.M.h.l.u.u.m.o. P.R.

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

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### Exactech® Optetrak Total Knee System Straight Stem Extensions - Additional Sizes

### Indications for Use

510(k) Number:

K. 2-25|

Device Name:

Optetrak Total Knee System Straight Stem Extensions

### INDICATIONS

The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

CAUTION: For cemented use only in the USA.

### CONTRAINDICATIONS

The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

smhheeein2

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012251

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over the Counter Use

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