Cleared Traditional

MCCUTCHEN ACETABULAR CUP PROSTHESIS (K872732) - FDA 510(k) Clearance

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

K872732 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
85d
Days
Class 2
Risk

K872732 is an FDA 510(k) clearance for the MCCUTCHEN ACETABULAR CUP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on October 1, 1987 after a review of 85 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 Dow Corning Wright devices

Submission Details

510(k) Number K872732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1987
Decision Date October 01, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K872732.
TITANIUM FEMORAL HIP
K881128 · Depuy, Inc. · Mar 1988
ANATOMIC TOTAL HIP
K874229 · Zimmer, Inc. · Nov 1987
POROUS COATED ACETABULAR CUP
K873585 · Johnson & Johnson Professionals, Inc. · Oct 1987
HPS II CALCAR FEMORAL PROSTHESIS
K871857 · Depuy, Inc. · Jun 1987
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
K870235 · Osteonics Corp. · May 1987
MODIFIED PROFILE HIP PMMA CEMENT SPACER
K871510 · Depuy, Inc. · May 1987