Signature ONE System
Summary
Orthosoft Inc. (d/b/a) Zimmer CAS received 510(k) clearance for Signature ONE System, a QHE device. Cleared on 2026-06-04.
Details
Source
510(k) Clearance
External ID
K261510
Action Date
2026-06-04
Status
Special
Category
device
Product Code
QHE
Product Description
Signature ONE System. Product code: QHE.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Orthosoft Inc. (d/b/a) Zimmer CAS has received 12 total clearances in our database.
Orthosoft Inc. (d/b/a) Zimmer CAS has 12 FDA actions in our database, including 12 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Orthosoft Inc. (d/b/a) Zimmer CAS have FDA actions?
Orthosoft Inc. (d/b/a) Zimmer CAS has 12 FDA actions in our database, including 0 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K261510" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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