Cleared Traditional

PROFORM POROUS ACETABULAR ASSEMBLY (K950827) - FDA 510(k) Clearance

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

K950827 · Stelkast Company · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
54d
Days
Class 2
Risk

K950827 is an FDA 510(k) clearance for the PROFORM POROUS ACETABULAR ASSEMBLY. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on April 18, 1995 after a review of 54 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 Stelkast Company devices

Submission Details

510(k) Number K950827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1995
Decision Date April 18, 1995
Days to Decision 54 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 122d · This submission: 54d
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 K950827.
PRECISION OSTEOLOCK FEMORAL COMPONENT
K944592 · Howmedica Corp. · May 1995
DEPUY DURALOC 100C ACETABULAR CUP
K951674 · Depuy, Inc. · May 1995
10.5MM REPLICA HIP STEM
K951095 · Depuy, Inc. · Apr 1995
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