Cleared Traditional

MITEK PDS/PGA STAPLE (K021953) - FDA 510(k) Clearance

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

K021953 · Mitek Worldwide · Orthopedic device
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Dec 2002
Decision
190d
Days
Class 2
Risk

K021953 is an FDA 510(k) clearance for the MITEK PDS/PGA STAPLE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Mitek Worldwide (Norwood, US). The FDA issued a Cleared decision on December 20, 2002 after a review of 190 days - an extended review 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: 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 Mitek Worldwide devices

Submission Details

510(k) Number K021953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2002
Decision Date December 20, 2002
Days to Decision 190 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 122d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K021953.
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · Wrightmedicaltechnologyinc · Jan 2005
ARTHROTEK MENISCAL HYBRID DEVICE
K041988 · Biomet, Inc. · Oct 2004
ORTHOPEDIC WIRE
K031127 · Howmedica Osteonics Corp. · Apr 2003
SURETAC III, MODELS 7209900, 7209901
K023417 · Smith & Nephew, Inc. · Nov 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · Smith & Nephew, Inc. · Oct 2002
LACTOSORB POP RIVET
K981798 · Biomet, Inc. · Jul 1998