Cleared Traditional

K930966 - BAUMER PLATES

K930966 is an FDA 510(k) clearance for BAUMER PLATES, manufactured by Baumer Ortopedia , Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 425-day FDA review.

K930966 · Baumer Ortopedia , Ltd. · Orthopedic device
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Apr 1994
Decision
425d
Days
Class 2
Risk

K930966 is an FDA 510(k) clearance for the BAUMER PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Baumer Ortopedia , Ltd. (Mogi Mirim-Sp-Brasil, BR). The FDA issued a Cleared decision on April 25, 1994 after a review of 425 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Baumer Ortopedia , Ltd. devices

FDA 510(k) Submission Details - K930966

510(k) Number K930966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1993
Decision Date April 25, 1994
Days to Decision 425 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
303d slower than avg
Panel avg: 122d · This submission: 425d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1311
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K930966.
EPIPHYSIS PLATE
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T-PLATE
K931692 · Onyx Medical Corp. · May 1994
MINI FRAGMENT PLATE
K934614 · Onyx Medical Corp. · May 1994
BUTTRESS PLATE
K931679 · Onyx Medical Corp. · Apr 1994
CLOVERLEAF PLATE
K931683 · Onyx Medical Corp. · Apr 1994
FOREARM SELF COMPRESSION PLATE
K931685 · Onyx Medical Corp. · Apr 1994