Exactech Equinoxe Stemless Shoulder
510(k) K173388
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173388 | Date9 Mar 2018 | 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- Withdrawn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
- PKC
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Exactech Equinoxe Stemless Shoulder is a prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained. It is classified as a Class II medical device under regulation number 888.3660 and product code PKC.
The device received FDA 510(k) clearance (K173388) on March 9, 2018, following a traditional review process. It was found substantially equivalent to a predicate device and is manufactured by Exactech, Inc. in Gainesville, Florida.
Other devices from Exactech, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the Exactech Equinoxe Stemless Shoulder used for?
It is a prosthesis designed for total anatomic shoulder replacement, specifically an uncemented metaphyseal humeral stem with no diaphyseal incursion and a semi-constrained design to restore joint function in shoulder arthroplasty procedures.
How is the Exactech Equinoxe Stemless Shoulder supplied and is it sterile?
The device is supplied as a sterile implant for single-use surgical procedures; sterility is maintained through validated manufacturing and packaging processes to ensure patient safety during implantation.
What regulatory pathway was used for the Exactech Equinoxe Stemless Shoulder?
It received FDA 510(k) clearance (K173388) on March 9, 2018, through a traditional review process, demonstrating substantial equivalence to a predicate device under regulation number 888.3660 and product code PKC.