Cleared Traditional

NEXUS II FEMORAL COMPONENT (K954262) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954262 · Wrightmedicaltechnologyinc · Orthopedic device
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Nov 1995
Decision
52d
Days
Class 2
Risk

K954262 is an FDA 510(k) clearance for the NEXUS II FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K954262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1995
Decision Date November 03, 1995
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K954262.
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
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K945774 · Wrightmedicaltechnologyinc · Dec 1995
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K951139 · Wrightmedicaltechnologyinc · Nov 1995
SLT 28MM XXL FEMORAL HEAD
K953025 · Wrightmedicaltechnologyinc · Sep 1995
ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K950418 · Wrightmedicaltechnologyinc · Jun 1995
OSTEONICS(R) CCR HIP STEM SERIES
K945574 · Osteonics Corp. · May 1995