Cleared Traditional

K894929 - STAPLE FIXATION SYSTEM

K894929 is an FDA 510(k) clearance for STAPLE FIXATION SYSTEM, manufactured by Concept, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K894929 · Concept, Inc. · Orthopedic device
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Aug 1989
Decision
28d
Days
Class 2
Risk

K894929 is an FDA 510(k) clearance for the STAPLE FIXATION SYSTEM. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Concept, Inc. (Largo, US). The FDA issued a Cleared decision on August 30, 1989 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Concept, Inc. devices

FDA 510(k) Submission Details - K894929

510(k) Number K894929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date August 30, 1989
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 124
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K894929.
HTO COMPRESSING STAPLE
K895117 · Howmedica Corp. · May 1990
MITEK ANCHOR(TM)
K897155 · Mitek Surgical Products, Inc. · Apr 1990
MITEK ANCHOR
K892126 · Mitek Surgical Products, Inc. · Sep 1989
ORTHOMET ORTHOPEDIC STAPLES
K874914 · Orthomet, Inc. · Feb 1988
KIRSCHNER BONE FIXATION FASTENER SYSTEM
K854445 · Kirschner Medical Corp. · Nov 1985
BONE STAPLING FIXATION SYS
K840566 · 3M Company · Nov 1984