Cleared Traditional

K012469 - RESORBABLE NO PROFILE SCREW AND WASHER

K012469 is an FDA 510(k) clearance for RESORBABLE NO PROFILE SCREW AND WASHER, manufactured by Biomet Manufacturing, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K012469 · Biomet Manufacturing, Inc. · Orthopedic device
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Dec 2001
Decision
123d
Days
Class 2
Risk

K012469 is an FDA 510(k) clearance for the RESORBABLE NO PROFILE SCREW AND WASHER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 123 days - within the typical 510(k) review window.

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. 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.

View all Biomet Manufacturing, Inc. devices

FDA 510(k) Submission Details - K012469

510(k) Number K012469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2001
Decision Date December 03, 2001
Days to Decision 123 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 122d · This submission: 123d
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 980
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K012469.
SELF-COUNTERSINKING BONE SCREW
K013534 · Biomet Orthopedics, Inc. · Dec 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · United States Surgical, A Division of Tyco Healthc · Dec 2001
REUNITE FUSION SCREW
K011451 · Biomet, Inc. · Dec 2001
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc. · Dec 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · Synthes (Usa) · Dec 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · Synthes (Usa) · Dec 2001