Cleared Traditional

K950250 - MED-SURG SUTURE WASHER

K950250 is an FDA 510(k) clearance for MED-SURG SUTURE WASHER, manufactured by Medical Surgical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K950250 · Medical Surgical, Inc. · Orthopedic device
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May 1995
Decision
114d
Days
Class 2
Risk

K950250 is an FDA 510(k) clearance for the MED-SURG SUTURE WASHER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medical Surgical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 17, 1995 after a review of 114 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 Medical Surgical, Inc. devices

FDA 510(k) Submission Details - K950250

510(k) Number K950250 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 23, 1995
Decision Date May 17, 1995
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
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 1017
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K950250.
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652 · Osteotech, Inc. · Jun 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · Synthes (Usa) · Jun 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · Smith & Nephew Richards, Inc. · Jun 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · Linvatec Corp. · May 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330 · Acu Med, Inc. · May 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426 · Arthrex, Inc. · Apr 1995