Cleared Traditional

K925872 - NORTHO BONE SCREW

K925872 is an FDA 510(k) clearance for NORTHO BONE SCREW, manufactured by Northo Orthopedics. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 1219-day FDA review.

K925872 · Northo Orthopedics · Orthopedic device
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Mar 1996
Decision
1219d
Days
Class 2
Risk

K925872 is an FDA 510(k) clearance for the NORTHO BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Northo Orthopedics (Las Cruces, US). The FDA issued a Cleared decision on March 22, 1996 after a review of 1219 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Northo Orthopedics devices

FDA 510(k) Submission Details - K925872

510(k) Number K925872 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 19, 1992
Decision Date March 22, 1996
Days to Decision 1219 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
1097d slower than avg
Panel avg: 122d · This submission: 1219d
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 787
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K925872.
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704 · Depuy, Inc. · Jun 1996
K3 BONE SCREW SYSTEM
K960533 · Kinetikos Medical, Inc. · Mar 1996
K2 BONE SCREW SYSTEM
K960537 · Kinetikos Medical, Inc. · Mar 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837 · Wrightmedicaltechnologyinc · Mar 1996
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246 · Acufex Microsurgical, Inc. · Feb 1996
MLI INTERFERENCE SCREW
K953350 · Medicinelodge, Inc. · Jan 1996