Cleared Traditional

K173491 - RTS Lesser MTP Implant System

K173491 is an FDA 510(k) clearance for RTS Lesser MTP Implant System, 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 102-day FDA review.

K173491 · In2bones USA, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
102d
Days
Class 2
Risk

K173491 is an FDA 510(k) clearance for the RTS Lesser MTP Implant System. 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 February 23, 2018 after a review of 102 days - within the typical 510(k) review window.

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 - K173491

510(k) Number K173491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date February 23, 2018
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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

Mrc-X, LLC
Christine Scifert

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 K173491.
NewPrim System
K191966 · Brm Extremities · Feb 2020
Fusion Silastic System
K190136 · Fusion Orthopedics, LLC · Oct 2019
RTS Flexible 1 MPJ Implant w/Grommets
K153609 · In2bones USA, LLC · Sep 2016
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