Cleared Traditional

K102424 - PREVISION HIP SYSTEM WITH RECON RING

K102424 is an FDA 510(k) clearance for PREVISION HIP SYSTEM WITH RECON RING, manufactured by Aesculap Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K102424

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
Combination Product No
PCCP Authorized No
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.

MEH Device Classification - Class 2, Special Controls

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 135
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K102424.
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
NOVEL TAPERED HIP STEM
K103479 · Stryker Corp. · Mar 2011
TRINITY ACETABULAR SYSTEM
K093472 · Corin USA · Nov 2010
SMITH & NEPHEW MDF MODULAR SLEEVE
K100481 · Smith & Nephew, Inc. · Jul 2010
SMITH & NEPHEW HIP SYSTEMS WITH HA
K090982 · Smith & Nephew, Inc. · Apr 2010