Cleared Traditional

K943054 - OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM

K943054 is an FDA 510(k) clearance for OSTEONICS SECURE-FIT AD ACETABULAR COMP..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

FDA 510(k) Submission Details - K943054

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.

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K943054.
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
K934515 · Zimmer, Inc. · Mar 1995
APOGEE HIP STEM WITH POROCOAT
K934334 · Depuy, Inc. · Dec 1994
ORTHOMET ACETABULAR CUP SYSTEM
K931333 · Orthomet, Inc. · Oct 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