Cleared Traditional

OSTEONICS SHOULDER PROSTHESIS (K862535) - FDA 510(k) Clearance

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

K862535 · Osteonics Corp. · Orthopedic device
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Sep 1986
Decision
62d
Days
Class 2
Risk

K862535 is an FDA 510(k) clearance for the OSTEONICS SHOULDER PROSTHESIS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 2, 1986 after a review of 62 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 Osteonics Corp. devices

Submission Details

510(k) Number K862535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1986
Decision Date September 02, 1986
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
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 91
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K862535.
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
K883816 · Osteonics Corp. · Nov 1988
NORMAL HUMERAL PROSTHESIS
K881750 · Osteonics Corp. · Aug 1988
FENLIN II SHOULDER PROSTHESIS
K870262 · Zimmer, Inc. · Apr 1987
MONOSPHERICAL GLENOID PROSTH. KEEL
K833410 · Howmedica Corp. · Nov 1983
UCLA SHOULDER
K801970 · Howmedica Corp. · Dec 1980