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The Tracker / September 2026 / K260063

510(k) cleared

GSPE Spacer

The General Hospital Corporation, d/b/a Massachusetts · Sep 11, 2026 · K260063

FDA cleared the GSPE Spacer from The General Hospital Corporation, d/b/a Massachusetts on Sep 11, 2026 under K260063, a traditional 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 8, 2026. The decision came 246 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for The General Hospital Corporation, d/b/a Massachusetts in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260063?

K260063 is the FDA 510(k) for GSPE Spacer, submitted by The General Hospital Corporation, d/b/a Massachusetts. FDA's decision date was Sep 11, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the GSPE Spacer?

The General Hospital Corporation, d/b/a Massachusetts, based in Somerville, MA, is the applicant of record for K260063.

How long did the K260063 review take?

FDA received the submission on Jan 8, 2026 and issued its decision on Sep 11, 2026, 246 days later.

← All decisions in September 2026

Sources