Cleared Traditional

K950833 - DEPUY SET SCREW

K950833 is an FDA 510(k) clearance for DEPUY SET SCREW, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K950833 · Depuy, Inc. · Orthopedic device
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Jul 1995
Decision
136d
Days
Class 2
Risk

K950833 is an FDA 510(k) clearance for the DEPUY SET SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 10, 1995 after a review of 136 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K950833

510(k) Number K950833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1995
Decision Date July 10, 1995
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 974
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K950833.
REUNION BONE SCREW SYSTEM
K951389 · Smith & Nephew Richards, Inc. · Jul 1995
ANSPACH SUTURE ANCHOR
K945525 · The Anspach Effort, Inc. · Jul 1995
ABSORBABLE ACETABULAR SCREW
K946347 · Zimmer, Inc. · Jul 1995
ORTHOPEDIC SCREW FIXATION
K932350 · Osteomed Corp. · Jul 1995
HARPOON SUTURE ANCHORS
K943806 · Biomet, Inc. · Jul 1995
LMT BONE ANCHOR
K951233 · Li Medical Technologies, Inc. · Jul 1995