Classic Great Toe Implant
510(k) K023086
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023086 | Date4 Oct 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3720
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Classic Great Toe Implant is a Prosthesis, Toe, Constrained, Polymer, designed as a dynamic joint spacer for first metatarsophalangeal joint arthroplasty. It features a double-stemmed silicone construction, providing structural support and articulation for the great toe joint. This device is intended for surgical implantation to restore function and mobility in patients with degenerative joint conditions or trauma affecting the first metatarsophalangeal joint.
The implant is surgically placed by a physician, with stems inserted into the intramedullary canals of the metatarsal and proximal phalanx. Supplied as a sterile, single-use device, it is regulated under FDA 510(k) clearance (K023086) and falls under the Orthopedic medical specialty. Compliance with 21 CFR 888.3720 ensures adherence to manufacturing and performance standards. No MRI safety or reusable specifications are noted in the regulatory data.
Other devices from Nexa Orthopedics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Classic Great Toe Implant used for?
The Classic Great Toe Implant is designed as a dynamic joint spacer for first metatarsophalangeal joint arthroplasty. It provides structural support and articulation to restore function and mobility in patients with degenerative joint conditions or trauma affecting the great toe joint. The implant is surgically placed to replace damaged joint surfaces, improving gait and daily activities.
How is the Classic Great Toe Implant supplied and sterilized?
The device is supplied as a sterile, single-use prosthesis. Sterility is maintained through validated manufacturing processes compliant with 21 CFR 888.3720, ensuring it is ready for immediate surgical use without reprocessing. This prevents cross-contamination and ensures patient safety.
Is the Classic Great Toe Implant reusable or intended for single use?
The device is explicitly intended for single-use only. Its sterile packaging and polymer construction are not designed for reprocessing or reuse, as this could compromise structural integrity, sterility, or patient safety. Single-use aligns with FDA 510(k) clearance requirements for orthopedic implants.
What materials is the Classic Great Toe Implant made from?
The implant features a double-stemmed construction made from silicone polymer. This material provides flexibility, durability, and biocompatibility for long-term joint articulation. The design ensures compatibility with bone integration while maintaining joint mobility.
How is the Classic Great Toe Implant implanted, and what does the procedure involve?
The implant is surgically placed by a physician, with stems inserted into the intramedullary canals of the metatarsal and proximal phalanx of the great toe. The procedure involves arthroplasty—removing damaged joint surfaces and positioning the implant to restore alignment and function. The double-stem design ensures stability while allowing natural joint motion.