Cleared Traditional

K930970 - BAUMER SCREWS

K930970 is an FDA 510(k) clearance for BAUMER SCREWS, manufactured by Baumer Ortopedia , Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K930970 · Baumer Ortopedia , Ltd. · Orthopedic device
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Jan 1994
Decision
317d
Days
Class 2
Risk

K930970 is an FDA 510(k) clearance for the BAUMER SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Baumer Ortopedia , Ltd. (Mogi Mirim-Sp-Brasil, BR). The FDA issued a Cleared decision on January 7, 1994 after a review of 317 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 - K930970

510(k) Number K930970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1993
Decision Date January 07, 1994
Days to Decision 317 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
195d slower than avg
Panel avg: 122d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 1032
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K930970.
6.5 MM CANCELLOUS BONE SCREW
K931665 · Encore Orthopedics, Inc. · Feb 1994
INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW
K930980 · Instrument Makar, Inc. · Feb 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187 · Implex Corp. · Feb 1994
BONE SCREWS
K923841 · Instrument Makar, Inc. · Oct 1993
ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR
K925328 · Anspach Mfg., Inc. · Oct 1993
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
K921481 · Acufex Microsurgical, Inc. · Aug 1993