Cleared Traditional

PREVISION HIP SYSTEM WITH RECON RING (K102424) - FDA 510(k) Clearance

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

K102424 · Aesculap Implant Systems, LLC · Orthopedic device
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Dec 2010
Decision
106d
Days
Class 2
Risk

K102424 is an FDA 510(k) clearance for the PREVISION HIP SYSTEM WITH RECON RING. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on December 9, 2010 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Aesculap Implant Systems, LLC devices

Submission Details

510(k) Number K102424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2010
Decision Date December 09, 2010
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 101
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K102424.
MODULAR PROXIMALLY FLUTED HIP STEM
K113789 · Smith & Nephew, Inc. · Apr 2012
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
K113320 · Exactech, Inc. · Mar 2012
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K112556 · Howmedica Osteonics Corp. · Sep 2011
SMITH & NEPHEW MDF MODULAR SLEEVE
K100481 · Smith & Nephew, Inc. · Jul 2010
SMITH & NEPHEW HIP SYSTEMS WITH HA
K090982 · Smith & Nephew, Inc. · Apr 2010
RESTORATION ADM SYSTEM X3 ACETABULAR
K093644 · Howmedica Osteonics Corp. · Dec 2009