Cleared Traditional

K931114 - SELECT(R) SHOULDER ALL-POLY GLENOID (FDA 510(k) Clearance)

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

K931114 · Intermedics Orthopedics · Orthopedic device
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May 1994
Decision
431d
Days
Class 2
Risk

K931114 is an FDA 510(k) clearance for the SELECT(R) SHOULDER ALL-POLY GLENOID. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on May 9, 1994 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Intermedics Orthopedics devices

Submission Details

510(k) Number K931114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1993
Decision Date May 09, 1994
Days to Decision 431 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 122d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 70
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