Cleared Traditional

K041988 - ARTHROTEK MENISCAL HYBRID DEVICE

K041988 is the FDA 510(k) clearance for ARTHROTEK MENISCAL HYBRID DEVICE by Biomet, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K041988 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
89d
Days
Class 2
Risk

K041988 is an FDA 510(k) clearance for the ARTHROTEK MENISCAL HYBRID DEVICE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 20, 2004 after a review of 89 days - a notably fast clearance 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: 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 Biomet, Inc. devices

Submission Details

510(k) Number K041988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date October 20, 2004
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 119
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K041988.
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052631 · Depuy Mitek, A Johnson & Johnson Company · Oct 2005
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
K051989 · Depuy Mitek, A Johnson & Johnson Company · Aug 2005
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · Wrightmedicaltechnologyinc · Jan 2005
GII QUICKANCHOR PLUS
K041115 · Depuy Mitek, A Johnson & Johnson Company · May 2004
ORTHOPEDIC WIRE
K031127 · Howmedica Osteonics Corp. · Apr 2003
SURETAC III, MODELS 7209900, 7209901
K023417 · Smith & Nephew, Inc. · Nov 2002