X-PSI Knee System— 510(k) K171269

Name: FDA 510(k) clearance K171269
Creator: U.S. Food and Drug Administration
Published: 2017-12-28

Substantially Equivalent

Orthosoft Inc (D/B/A Zimmer Cas)

FDA 510(k) clearance K171269 for X-PSI Knee System, Substantially Equivalent on 2017-12-28. Applicant: Orthosoft Inc (D/B/A Zimmer Cas). Device class: 2.

Clearance details

Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2017-05-01
Decision date: 2017-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

More clearances from Orthosoft Inc (D/B/A Zimmer Cas)

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K261510 — Signature ONE System2026-06-04
K260582 — ROSA® Shoulder System2026-05-21
K260104 — Signature ONE System2026-02-04
K251314 — Rosa® Knee System2025-11-13
K242864 — ROSA® Knee System2024-10-18

Adverse 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, 2020-01-01 through 2026-04-23. 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.