Cleared Special

ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS (K051335) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051335 · Exactech, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2005
Decision
29d
Days
Class 2
Risk

K051335 is an FDA 510(k) clearance for the ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on June 21, 2005 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exactech, Inc. devices

Submission Details

510(k) Number K051335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2005
Decision Date June 21, 2005
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K051335.
TRABECULAR METAL REVISION SHELL LINERS
K051516 · Zimmer, Inc. · Jul 2005
TAPER 2 POROUS FEMORAL STEM
K050441 · Biomet, Inc. · Jun 2005
RESTORATION MODULAR SYSTEM
K051363 · Howmedica Osteonics Corp. · Jun 2005
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
K050105 · Zimmer, Inc. · May 2005
MODIFICATION TO: RESTORATION MODULAR SYSTEM
K050138 · Howmedica Osteonics Corp. · Mar 2005
DEPUY C-STEM AMT HIP PROSTHESIS
K042959 · DePuy Orthopaedics, Inc. · Dec 2004