Cleared Traditional

K953650 - DEPUY STAINLESS STEEL SET SCREW

K953650 is the FDA 510(k) clearance for DEPUY STAINLESS STEEL SET SCREW by Depuy, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K953650 · Depuy, Inc. · Orthopedic device
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Nov 1995
Decision
91d
Days
Class 2
Risk

K953650 is an FDA 510(k) clearance for the DEPUY STAINLESS STEEL 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 November 3, 1995 after a review of 91 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

Submission Details

510(k) Number K953650 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 04, 1995
Decision Date November 03, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 609
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K953650.
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246 · Acufex Microsurgical, Inc. · Feb 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303 · Arthrex, Inc. · Jan 1996
FIXANO D.D.S. (DOUBLE SLIDING SCREW)
K954757 · Ferguson Medical · Jan 1996
STRYKER ACL INTERFERENCE SCREW SYSTEM
K952460 · Stryker Endoscopy · Sep 1995
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K952831 · Linvatec Corp. · Sep 1995
TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
K952697 · Smith & Nephew Richards, Inc. · Sep 1995