Cleared Traditional

K873585 - POROUS COATED ACETABULAR CUP

K873585 is the FDA 510(k) clearance for POROUS COATED ACETABULAR CUP by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K873585 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Oct 1987
Decision
54d
Days
Class 2
Risk

K873585 is an FDA 510(k) clearance for the POROUS COATED ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K873585 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 04, 1987
Decision Date October 28, 1987
Days to Decision 54 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K873585.
HI-NEK TOTAL HIP
K873632 · Orthopedic Systems, Inc. · Dec 1987
WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS
K873857 · Dow Corning Wright · Dec 1987
ANATOMIC TOTAL HIP
K874229 · Zimmer, Inc. · Nov 1987
PREMIER-TOTAL (TM) HIP
K873999 · Intermedics Orthopedics · Oct 1987
MCCUTCHEN ACETABULAR CUP PROSTHESIS
K872732 · Dow Corning Wright · Oct 1987
BIOPRO 32MM BALL
K872856 · Biopro, Inc. · Aug 1987