Cleared Traditional

PAPILLOTOME (K901434) - FDA 510(k) Clearance

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

K901434 · Telemed Systems, Inc. · Orthopedic device
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Jun 1990
Decision
74d
Days
Class 2
Risk

K901434 is an FDA 510(k) clearance for the PAPILLOTOME. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on June 8, 1990 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 Telemed Systems, Inc. devices

Submission Details

510(k) Number K901434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 08, 1990
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 92
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K901434.
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
K950521 · Osteonics Corp. · Jun 1995
DEPUY POROUS COATED GLOBAL SHOULDER
K943300 · Depuy, Inc. · Oct 1994
NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT
K902855 · Depuy, Inc. · Sep 1990
NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
K895226 · 3M Company · Nov 1989
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
K883816 · Osteonics Corp. · Nov 1988
NORMAL HUMERAL PROSTHESIS
K881750 · Osteonics Corp. · Aug 1988