K023186 · Exactech, Inc. · JWH · Oct 17, 2002 · Orthopedic
Device Facts
Record ID
K023186
Device Name
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
Applicant
Exactech, Inc.
Product Code
JWH · Orthopedic
Decision Date
Oct 17, 2002
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3560
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Offset Tibial Tray components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. The Optetrak Offset Tibial Tray is intended for use when the tibial intramedullary (IM) canal is offset from the tibial plateau.
Device Story
Offset Tibial Tray is a component of the Optetrak Total Knee System; designed for primary or revision total knee arthroplasty. Features an offset distal stem to accommodate varying patient anatomy where the tibial intramedullary canal is offset from the tibial plateau. Used by orthopedic surgeons in a clinical/OR setting. Device replaces proximal tibia; maintains compatibility with existing Optetrak tibial inserts, augmentations, and stem extensions. Modified screws facilitate attachment of constrained condylar inserts and stem extensions. Provides structural support for knee joint reconstruction; benefits patients by allowing anatomical alignment in complex cases. Cemented use only in the USA.
Clinical Evidence
Bench testing only. Functional testing was conducted to verify that the implant performance would be adequate for anticipated in vivo loading.
Technological Characteristics
Material: Titanium alloy (Ti 6 Al 4V) conforming to ASTM F-136. Design: Offset distal portion of the tibial tray stem. Compatibility: Maintains mating features with existing Optetrak tibial inserts, augmentation components, and stem extensions. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified.
Indications for Use
Indicated for skeletally mature individuals undergoing primary total knee replacement for osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative problems; also 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 causing extreme loads/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).
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K033186 pg 142
# Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)
# Summary of Safety and Effectiveness
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## Device Information:
## INTENDED USE
The Offset Tibial Tray components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. The Optetrak Offset Tibial Tray is intended for use when the tibial intramedullary (IM) canal is offset from the tibial plateau.
## 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.
## 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.
## CAUTION: In the USA, for cemented use only.
#### Device Modifications
The device modifications presented in this Special 510(k) represent changes to the Tibial Tray Components of the Optetrak Total Knee System (premarket notifications #K933610 and #K011976). No changes were made to the other components of the Optetrak Total Knee System.
The proposed device modifications involve offsetting the distal portion of the tray's stem in the sizes 0, 1 Delta, 1, 2, 3, 4 and 5. This is done in order to accommodate varying patient anatomies.
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# Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)
## Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
No modifications have been made to the mating features of the Tibial Tray in order to maintain the full mating capabilities with all tibial inserts, augmentation components and stem extensions of the predicate Optetrak Total Knee System
The proposed offset design incorporates modified screws for attachment of the Constrained Condylar Tibial Inserts and the Tibial Stem Extensions.
There have been no changes to the material of the predicate Optetrak Tibial Tray components. Like the predicate Optetrak Tibial Tray components (#K933610 & #K011976), the proposed tray components are manufactured from titanium alloy (Ti 6 Al 4V) conforming to ASTM F-136.
# PERFORMANCE DATA SUMMARY
Functional testing was conducted to verify that the implant performance would be adequate for anticipated in vivo loading.
We conclude that the Optetrak Offset Tibial components are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of curved lines and shapes, creating a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# OCT 1 7 2002
Mr. Martin Sprunck Regulatory Representative Exactech, Inc. . 2320 NW 66" Court Gainesville, Florida 32653
Re: K023186
Trade/Device Name: OPTETRAK® Total Knee System Offset Tibial Tray Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 19, 2002 Received: September 24, 2002
Dear Mr. Sprunck :
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 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.
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Page 2 - Mr. Martin Sprunck
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,
Sincerly, yours,
O. Mark N. Melleuson
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)
#### Indications for Use : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Number:
KO23186
Device Name:
Offset Tibial Tray
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.
#### 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.
CAUTION: In the USA, for cemented use only.
Mark A. Milburn
Division of General, Restorative and Neurological Devices
510(k) Number K023186
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over the Counter Use No
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