Cleared Traditional

K931155 - STAPLE

Also marketed or referenced as:
SCREW FIXATION BONE

K931155 is an FDA 510(k) clearance for STAPLE, manufactured by Roseburg SA. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 541-day FDA review.

K931155 · Roseburg SA · Orthopedic device
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Sep 1994
Decision
541d
Days
Class 2
Risk

K931155 is an FDA 510(k) clearance for the STAPLE, FIXATION BONE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on September 1, 1994 after a review of 541 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 Roseburg SA devices

FDA 510(k) Submission Details - K931155

510(k) Number K931155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date September 01, 1994
Days to Decision 541 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
419d slower than avg
Panel avg: 122d · This submission: 541d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K931155.
AIMS CANNULATED ACL SCREW
K943539 · Smith & Nephew, Inc. · Oct 1994
MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
K934366 · Mitek Surgical Products, Inc. · Oct 1994
PIONEER LABORATORIES CABLE PIN
K941174 · Pioneer Surgical Technology · Sep 1994
ARTHROTEK SET SCREW
K932721 · Biomet, Inc. · Aug 1994
TITANIUM ALLOY BONE SCREWS
K940207 · Aesculap, Inc. · Jul 1994
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K933719 · Linvatec Corp. · May 1994