Cleared Traditional

OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM (K954023) - FDA 510(k) Clearance

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

K954023 · Osteonics Corp. · Orthopedic device
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Nov 1995
Decision
86d
Days
Class 2
Risk

K954023 is an FDA 510(k) clearance for the OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 K954023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date November 22, 1995
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 102
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K954023.
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
K963959 · Osteonics Corp. · Dec 1996
PCA +15MM MODULAR FEMORAL HEAD
K955305 · Howmedica Corp. · Jan 1996
OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES
K951517 · Osteonics Corp. · Jan 1996
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
K951671 · Osteonics Corp. · Sep 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K951932 · Osteonics Corp. · Sep 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K951291 · Osteonics Corp. · Aug 1995