Cleared Traditional

OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM (K943054) - FDA 510(k) Clearance

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

K943054 · Osteonics Corp. · Orthopedic device
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Oct 1994
Decision
99d
Days
Class 2
Risk

K943054 is an FDA 510(k) clearance for the OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 99 days - within the typical 510(k) review window.

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. 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 Osteonics Corp. devices

Submission Details

510(k) Number K943054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date October 04, 1994
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K943054.
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K951301 · Depuy, Inc. · Apr 1995
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
K934515 · Zimmer, Inc. · Mar 1995
APOGEE HIP STEM WITH POROCOAT
K934334 · Depuy, Inc. · Dec 1994
PRECISION OSTELOCK SP FEMORAL COMPONENT
K941141 · Howmedica Corp. · Sep 1994
INFINITY REVISION HIP STEM
K942115 · Wrightmedicaltechnologyinc · Sep 1994
OSTEONICS SCREWLESS ACETABULAR COMPONENTS
K935875 · Osteonics Corp. · Jul 1994