Cleared Traditional

K852365 - LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM (FDA 510(k) Clearance)

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

K852365 · Link America, Inc. · Orthopedic device
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Dec 1985
Decision
195d
Days
Class 2
Risk

K852365 is an FDA 510(k) clearance for the LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Link America, Inc. (East Hanavor, US). The FDA issued a Cleared decision on December 16, 1985 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Link America, Inc. devices

Submission Details

510(k) Number K852365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1985
Decision Date December 16, 1985
Days to Decision 195 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 122d · This submission: 195d
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 189
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K852365.
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