Cleared Special

K262290 - REMEDY POLY+PLUS SNAP FIT Acetabular Cup

K262290 is an FDA 510(k) clearance for REMEDY POLY+PLUS SNAP FIT Acetabular Cup, manufactured by Osteoremedies, LLC. The device is a Class 2 Orthopedic device with product code KWL cleared through the Special 510(k) pathway after a 18-day FDA review.

K262290 · Osteoremedies, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
18d
Days
Class 2
Risk

K262290 is an FDA 510(k) clearance for the REMEDY POLY+PLUS SNAP FIT Acetabular Cup. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Osteoremedies, LLC (Germantown, US). The FDA issued a Cleared decision on July 24, 2026 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262290

510(k) Number K262290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2026
Decision Date July 24, 2026
Days to Decision 18 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

KWL Device Classification - Class 2, Special Controls

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

MCRA,LLC
Hollace Saas Rhodes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 107
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K262290.
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K222632 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2022
K262290 · REMEDY POLY+PLUS SNAP FIT Acetabular Cup
Download PDF FDA Summary Osteoremedies, LLC