Freedom Partial Knee System— 510(k) K261609

Name: FDA 510(k) clearance K261609
Creator: U.S. Food and Drug Administration
Published: 2026-08-04

Substantially Equivalent

Maxx Orthopedics, Inc.

FDA 510(k) clearance K261609 for Freedom Partial Knee System, Substantially Equivalent on 2026-08-04. Applicant: Maxx Orthopedics, Inc.. Device class: 2.

Summary

Maxx Orthopedics' Freedom Partial Knee System is filed under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer). The record gives no sizes or components.

Class II, 21 CFR 888.3520. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Maxx filed from Norristown, Pennsylvania. The substantially equivalent decision came 82 calendar days after receipt (May 14 to August 4, 2026).

Clearance details

Applicant: Maxx Orthopedics, Inc.
Product code: Product code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 2026-05-14
Decision date: 2026-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norristown, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSX

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K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat2026-04-02
K251771 — Cambridge Partial Knee2025-12-16
K251834 — Persona Partial Knee2025-08-15
K251618 — MOTO Partial Knee System Extension2025-07-24
K251453 — Arthrex iBalance Partial Knee System2025-07-01

More clearances from Maxx Orthopedics, Inc.

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.