Cleared Traditional

HIP JOINT PROTHESIS (K921400) - FDA 510(k) Clearance

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

K921400 · Smith & Nephew Richards, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
374d
Days
Class 2
Risk

K921400 is an FDA 510(k) clearance for the HIP JOINT PROTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on April 2, 1993 after a review of 374 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K921400 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 24, 1992
Decision Date April 02, 1993
Days to Decision 374 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 122d · This submission: 374d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K921400.
INFINITY POROUS-COATED TROCHANTERIC MODULE
K922159 · Wrightmedicaltechnologyinc · Oct 1993
ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
K926107 · Biomet, Inc. · Jul 1993
OSTEONICS MICROSUTERED FEMORAL COMPONENTES
K926201 · Osteonics Corp. · Jun 1993
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
K921639 · Zimmer, Inc. · Jul 1992
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
K862702 · Depuy, Inc. · Jul 1986
POROUS COATED HIP FEMORAL PROSTHESIS
K862326 · Johnson & Johnson Professionals, Inc. · Jul 1986