Cleared Traditional

OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (K983502) - FDA 510(k) Clearance

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

K983502 · Osteonics Corp. · Orthopedic device
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Dec 1998
Decision
71d
Days
Class 2
Risk

K983502 is an FDA 510(k) clearance for the OSTEONICS SECUR-FIT AD GENERATION II 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 December 16, 1998 after a review of 71 days - a notably fast clearance cycle.

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: 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 Osteonics Corp. devices

Submission Details

510(k) Number K983502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1998
Decision Date December 16, 1998
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 K983502.
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
K984296 · Biomet, Inc. · Feb 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
K984408 · Biomet, Inc. · Feb 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
K984459 · DePuy Orthopaedics, Inc. · Jan 1999
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
K983491 · DePuy Orthopaedics, Inc. · Dec 1998
CUSTOM FLANGED ACETABULAR COMPONENT
K983035 · Biomet, Inc. · Nov 1998
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K980711 · Zimmer, Inc. · Nov 1998