Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert

510(k) K243817

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK243817	Date6 Feb 2025Cleared	StatusActive

2 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-3206-2026 FDA Class II initiated 30 Jul 2026 on shared 510(k) K243817
- Ongoing Z-3197-2026 FDA Class II initiated 30 Jul 2026
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K243817
FDA Product Code: JWH
Models / Variants: Scorpio Universal Dome Patella
Scorpio Total Stabilizer Insert
Scorpio-Flex Posterior Stabilized Tibial Insert
Scorpio-Flex Cruciate Retaining Tibial Insert
Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert
Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert