Cleared Traditional

K101622 - ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS

K101622 is an FDA 510(k) clearance for ZIMMER NATURAL NAIL SYSTEM RETROGRADE F..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K101622 · Zimmer, Inc. · Orthopedic device
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Oct 2010
Decision
114d
Days
Class 2
Risk

K101622 is an FDA 510(k) clearance for the ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 1, 2010 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K101622

510(k) Number K101622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2010
Decision Date October 01, 2010
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 465
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K101622.
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
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T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
K102992 · Howmedica Osteonics Corp. · Dec 2010
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
K101939 · Merete Medical GmbH · Oct 2010
ASCENSION ANKLE FUSION NAIL SYSTEM
K100925 · Ascension Orthopedics, Inc. · Jul 2010
WRIST ARTHRODESIS NAIL SYSTEM
K092720 · Skeletal Dynamics, LLC · Jun 2010
T2 GREATER TROCHANTER NAIL
K101438 · Howmedica Osteonics Corp. · Jun 2010