Cleared Traditional

K930969 - BAUMER PINS

K930969 is an FDA 510(k) clearance for BAUMER PINS, manufactured by Baumer Ortopedia , Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K930969 · Baumer Ortopedia , Ltd. · Orthopedic device
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Mar 1994
Decision
398d
Days
Class 2
Risk

K930969 is an FDA 510(k) clearance for the BAUMER PINS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Baumer Ortopedia , Ltd. (Mogi Mirim-Sp-Brasil, BR). The FDA issued a Cleared decision on March 29, 1994 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Baumer Ortopedia , Ltd. devices

FDA 510(k) Submission Details - K930969

510(k) Number K930969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1993
Decision Date March 29, 1994
Days to Decision 398 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
276d slower than avg
Panel avg: 122d · This submission: 398d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 190
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K930969.
SPETZLER PIN
K945639 · Howmedica Corp. · Apr 1995
BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE
K925098 · Bioscience, Inc. · Jul 1994
ACUFEX SMOOTH AND THREADED PINS
K931836 · Acufex Microsurgical, Inc. · Jun 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · Osteomed Corp. · Mar 1994
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc. · Jul 1993
OTI ORTHOPEDIC FASTENER SYSTEM
K925301 · Osteo Technology, Inc. · Mar 1993