Cleared Traditional

K964970 - BIOMET BONE SCREW

K964970 is an FDA 510(k) clearance for BIOMET BONE SCREW, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K964970 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
112d
Days
Class 2
Risk

K964970 is an FDA 510(k) clearance for the BIOMET BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 3, 1997 after a review of 112 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, Inc. devices

FDA 510(k) Submission Details - K964970

510(k) Number K964970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1996
Decision Date April 03, 1997
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 K964970.
OSTEO SMALL AND MINI BONE SCREWS
K971778 · Osteonics Corp. · Jun 1997
DEPUY LOW PROFILE BONE SCREW
K970929 · Depuy, Inc. · Jun 1997
TITANIUM ALLOY BONE SCREWS
K970549 · Aesculap, Inc. · Apr 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · Smith & Nephew, Inc. · Feb 1997
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K963739 · Howmedica Leibinger, Inc. · Jan 1997
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
K963937 · Northwest Precision Technologies · Jan 1997