Cleared Traditional

REUNION BONE SCREW SYSTEM (K951389) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951389 · Smith & Nephew Richards, Inc. · Orthopedic device
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Jul 1995
Decision
119d
Days
Class 2
Risk

K951389 is an FDA 510(k) clearance for the REUNION BONE SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on July 24, 1995 after a review of 119 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K951389 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 27, 1995
Decision Date July 24, 1995
Days to Decision 119 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 122d · This submission: 119d
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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K951389.
DEPUY STAINLESS STEEL SET SCREW
K953650 · Depuy, Inc. · Nov 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296 · Synthes (Usa) · Aug 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272 · Synthes (Usa) · Jul 1995
ABSORBABLE ACETABULAR SCREW
K946347 · Zimmer, Inc. · Jul 1995
DEPUY SET SCREW
K950833 · Depuy, Inc. · Jul 1995
HARPOON SUTURE ANCHORS
K943806 · Biomet, Inc. · Jul 1995