RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attac
Summary
Stryker Instruments received 510(k) clearance for RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer, a OLO device. Cleared on 2025-09-25.
Details
Source
510(k) Clearance
External ID
K251971
Action Date
2025-09-25
Status
Traditional
Category
device
Product Code
OLO
Product Description
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer. Product code: OLO.
Company
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. Stryker Instruments has received 15 total clearances in our database.
Stryker Instruments has 16 FDA actions in our database, including 1 recall and 15 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 Stryker Instruments have FDA actions?
Stryker Instruments has 16 FDA actions in our database, including 1 recall and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251971" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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