Cleared Traditional

K930319 - OSTEON ADAPTOR/CRADLE

K930319 is an FDA 510(k) clearance for OSTEON ADAPTOR/CRADLE, manufactured by United American Medical Co., Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K930319 · United American Medical Co., Inc. · Orthopedic device
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Jan 1994
Decision
350d
Days
Class 1
Risk

K930319 is an FDA 510(k) clearance for the OSTEON ADAPTOR/CRADLE. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by United American Medical Co., Inc. (Mc Minnville, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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. Elevated predicate reliance profile. 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 United American Medical Co., Inc. devices

FDA 510(k) Submission Details - K930319

510(k) Number K930319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1993
Decision Date January 07, 1994
Days to Decision 350 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 122d · This submission: 350d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 60
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K930319.
INTERMEDICS ORTHOPEDICS DRILL BITS
K931734 · Intermedics Orthopedics · Feb 1994
BONE SAW BLADES
K931176 · Betzler Mfg., Inc. · Jan 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · Arthrex, Inc. · Jan 1994
POWERED SURGICAL INSTRUMENT ACCESSORY
K930363 · Intenn Engineering, Inc. · Jan 1994
ACUFEX STERILE DRILLS
K931837 · Acufex Microsurgical, Inc. · Jan 1994
CKS OSCILLATING SAW BLADE
K921131 · Techmedica, Inc. · Jun 1992