GSPE Spacer— 510(k) K260063
Substantially EquivalentThe General Hospital Corporation, d/b/a Massachusetts
FDA 510(k) clearance K260063 for GSPE Spacer, Substantially Equivalent on 2026-09-11. Applicant: The General Hospital Corporation, d/b/a Massachusetts. Device class: 2.
Summary
The GSPE Spacer is filed under JWH, semi-constrained cemented knee prostheses with polymer/metal/polymer construction. A "spacer" under a knee replacement code often means a temporary or staged implant. The record doesn't state the intended use, so that's a reading of the name and nothing more.
Class II, 21 CFR 888.3560. The Orthopedic panel reviewed it as a Traditional 510(k).
Look at the applicant: The General Hospital Corporation, the legal entity behind Massachusetts General Hospital. FDA's record cuts the name off after "d/b/a Massachusetts." It filed from Somerville, Massachusetts. Hospitals don't hold many 510(k)s, and the ones they do tend to come out of in-house device work. Review took 246 days (January 8 to September 11, 2026).
Clearance details
- Applicant
- The General Hospital Corporation, d/b/a Massachusetts
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, MA, US
Recent devices under product code JWH
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.