Optertrak Logic Psc Tibial Insert
by Exactech Sarasota 510(k)
Active
510(k) K110547
Overview
The Optertrak Logic Psc Tibial Insert is a modification of the existing Optetrak Logic Total Knee System. It features a central spine with increased medial/lateral thickness compared to the predicate, providing 2°-3° additional varus/valgus constraint for patients with minor ligament laxity.
This device is a Class 2 Orthopedic device with product code JWH, manufactured by Exactech Sarasota. It is supplied as a single-use device and is MRI conditional. The device is cleared through the Special 510(k) pathway after a 48-day FDA review with FDA 510(k) clearance number K110547.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110547 | Date14 Apr 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Exactech Sarasota
Questions
What is the Optertrak Logic Psc Tibial Insert used for?
The Optertrak Logic Psc Tibial Insert is a modification of the Optetrak Logic Total Knee System, designed to provide 2°-3° additional varus/valgus constraint for patients with minor ligament laxity.
How is the Optertrak Logic Psc Tibial Insert supplied?
The device is supplied as a single-use device and is MRI conditional. It is manufactured by Exactech Sarasota and is classified as a Class 2 Orthopedic device with product code JWH.
What is the regulatory status of the Optertrak Logic Psc Tibial Insert?
The device is cleared through the Special 510(k) pathway after a 48-day FDA review with FDA 510(k) clearance number K110547. It was determined to be substantially equivalent to the predicate device.
What are the key features of the Optertrak Logic Psc Tibial Insert?
The device features a central spine with increased medial/lateral thickness compared to the predicate, providing additional constraint for patients with minor ligament laxity. It is designed for use in total knee arthroplasty procedures.