Cleared Traditional

K023531 - LESSER METATARSAL PHALANGEAL JOINT IMPLANT

K023531 is an FDA 510(k) clearance for LESSER METATARSAL PHALANGEAL JOINT IMPLANT, manufactured by Nexa Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K023531 · Nexa Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2003
Decision
88d
Days
Class 2
Risk

K023531 is an FDA 510(k) clearance for the LESSER METATARSAL PHALANGEAL JOINT IMPLANT. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Nexa Orthopedics, Inc. (Vista, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nexa Orthopedics, Inc. devices

FDA 510(k) Submission Details - K023531

510(k) Number K023531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2002
Decision Date January 17, 2003
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 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 K023531.
Fusion Silastic System
K190136 · Fusion Orthopedics, LLC · Oct 2019
RTS Lesser MTP Implant System
K173491 · In2bones USA, LLC · Feb 2018
RTS Flexible 1 MPJ Implant w/Grommets
K153609 · In2bones USA, LLC · Sep 2016
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · Osteomed Corp. · Nov 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · Osteomed Corp. · Nov 2002
MODIFICATION TO CLASSIC GREAT TOE IMPLANT
K023562 · Nexa Orthopedics, Inc. · Nov 2002