Cleared Traditional

K153609 - RTS Flexible 1 MPJ Implant w/Grommets

K153609 is an FDA 510(k) clearance for RTS Flexible 1 MPJ Implant w/Grommets, manufactured by In2bones USA, LLC. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K153609 · In2bones USA, LLC · Orthopedic device
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Sep 2016
Decision
266d
Days
Class 2
Risk

K153609 is an FDA 510(k) clearance for the RTS Flexible 1 MPJ Implant w/Grommets. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on September 8, 2016 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3720 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all In2bones USA, LLC devices

FDA 510(k) Submission Details - K153609

510(k) Number K153609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2015
Decision Date September 08, 2016
Days to Decision 266 days
Submission Type Traditional
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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWH Device Classification - Class 2, Special Controls

Product Code KWH Prosthesis, Toe, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3720
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

Enmed International, Inc.
Louise Focht

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 - KWH Prosthesis, Toe, Constrained, Polymer

All 14
Devices cleared under the same product code (KWH) and FDA review panel - the closest regulatory comparables to K153609.
NewPrim System
K191966 · Brm Extremities · Feb 2020
Fusion Silastic System
K190136 · Fusion Orthopedics, LLC · Oct 2019
RTS Lesser MTP Implant System
K173491 · In2bones USA, LLC · Feb 2018
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
K023531 · Nexa Orthopedics, Inc. · Jan 2003
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · Osteomed Corp. · Nov 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · Osteomed Corp. · Nov 2002