Balanced Knee Revision System Trabecular Tibial Cone Augments— 510(k) K182085

Name: FDA 510(k) clearance K182085
Creator: U.S. Food and Drug Administration
Published: 2018-10-31

Substantially Equivalent

Ortho Development Corporation

FDA 510(k) clearance K182085 for Balanced Knee Revision System Trabecular Tibial Cone Augments, Substantially Equivalent on 2018-10-31. Applicant: Ortho Development Corporation. Device class: 2.

Clearance details

Applicant: Ortho Development Corporation
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2018-08-02
Decision date: 2018-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

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

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K211471 — Balanced Knee System Uni2021-12-16
K203023 — Pisces Spinal System2021-07-14
K200281 — The Gecko Spinal System2020-03-31

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.