Cleared Traditional

BAUMER STAPLES (K930967) - FDA 510(k) Clearance

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

K930967 · Baumer Ortopedia , Ltd. · Orthopedic device
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Mar 1994
Decision
376d
Days
Class 2
Risk

K930967 is an FDA 510(k) clearance for the BAUMER STAPLES. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Baumer Ortopedia , Ltd. (Mogi Mirim-Sp-Brasil, BR). The FDA issued a Cleared decision on March 7, 1994 after a review of 376 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: 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

Submission Details

510(k) Number K930967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1993
Decision Date March 07, 1994
Days to Decision 376 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
254d slower than avg
Panel avg: 122d · This submission: 376d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 66
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K930967.
HOWMEDICA MAINSTAY ANCHOR
K953531 · Howmedica Corp. · Sep 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950 · Ethicon, Inc. · May 1995
ARTHREX STAPLES
K943492 · Arthrex, Inc. · Feb 1995
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · Zimmer, Inc. · Nov 1993
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993
BONE STAPLE(S)
K904553 · Synthes (Usa) · Dec 1990