Cleared Traditional

K243192 - iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

K243192 is an FDA 510(k) clearance for iNSitu Lateralized Acetabular Liners, manufactured by Nextstep Arthopedix, LLC. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 613-day FDA review.

K243192 · Nextstep Arthopedix, LLC · Orthopedic device
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Jun 2026
Decision
613d
Days
Class 2
Risk

K243192 is an FDA 510(k) clearance for the iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Spraye.... Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Nextstep Arthopedix, LLC (Akron, US). The FDA issued a Cleared decision on June 5, 2026 after a review of 613 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Nextstep Arthopedix, LLC devices

FDA 510(k) Submission Details - K243192

510(k) Number K243192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date June 05, 2026
Days to Decision 613 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
491d slower than avg
Panel avg: 122d · This submission: 613d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 534
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K243192.
Mpact 3D Metal Foam
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K254043 · Globus Medical, Inc. · Aug 2026
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Taperloc® Complete Hip Stem
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G7® Revision Acetabular System
K252623 · Zimmer, Inc. · Feb 2026
Mpact 3D Metal Implants Extension – DMLS Technology
K251043 · Medacta International S.A. · Jan 2026