Cleared Traditional

K011504 - BAUMER LOCKING NAIL

K011504 is an FDA 510(k) clearance for BAUMER LOCKING NAIL, manufactured by Baumer, S.A. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K011504 · Baumer, S.A · Orthopedic device
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Aug 2001
Decision
90d
Days
Class 2
Risk

K011504 is an FDA 510(k) clearance for the BAUMER LOCKING NAIL. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Baumer, S.A (Mogi Mirim, Sao Paulo, BR). The FDA issued a Cleared decision on August 14, 2001 after a review of 90 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K011504

510(k) Number K011504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2001
Decision Date August 14, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDS Device Classification - Class 2, Special Controls

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K011504.
NORMED COMPRESSION BONE SCREW SYSTEM
K032634 · Noviace Corporation · Oct 2003
BNF
K021782 · Aap Implantate AG · Aug 2002
ODI TALON INTRAMEDULLARY HIP NAIL
K014189 · Orthopedic Designs, Inc. · Mar 2002
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212 · Disco-O-Tech Medical Technologies, Ltd. · Dec 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215 · Disco-O-Tech Medical Technologies, Ltd. · Dec 2000
WUJIN #3 TIBIAL NAIL
K002325 · Biologically Oriented Prostheses · Oct 2000
K011504 · BAUMER LOCKING NAIL
Download PDF Baumer, S.A