Cleared Traditional

EXTERNAL FIXATION ANCHOR PIN (K001228) - FDA 510(k) Clearance

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

K001228 · Immedica, Inc. · Orthopedic device
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Jul 2000
Decision
81d
Days
Class 2
Risk

K001228 is an FDA 510(k) clearance for the EXTERNAL FIXATION ANCHOR PIN. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Immedica, Inc. (Chatham, US). The FDA issued a Cleared decision on July 7, 2000 after a review of 81 days - a notably fast clearance cycle.

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: 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 Immedica, Inc. devices

Submission Details

510(k) Number K001228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2000
Decision Date July 07, 2000
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 38
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K001228.
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · Biomet, Inc. · Nov 2000
SYNTHES SACRAL BAR SYSTEM
K001720 · Synthes (Usa) · Aug 2000
APEX FIXATION PINS
K001886 · Howmedica Osteonics Corp. · Jul 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
K994143 · Smith & Nephew, Inc. · Feb 2000
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · Depuy, Inc. · Jul 1999
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068 · Howmedica Corp. · Aug 1998