Cleared Traditional

K994121 - SMALL STATURE USS

K994121 is the FDA 510(k) clearance for SMALL STATURE USS by Synthes (Usa). It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K994121 · Synthes (Usa) · Orthopedic device
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Oct 2000
Decision
316d
Days
Class 2
Risk

K994121 is an FDA 510(k) clearance for the SMALL STATURE USS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on October 17, 2000 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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. Elevated predicate reliance profile. 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 Synthes (Usa) devices

Submission Details

510(k) Number K994121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date October 17, 2000
Days to Decision 316 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
194d slower than avg
Panel avg: 122d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 152
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K994121.
MONARCH SPINE SYSTEM
K010576 · Depuyacromed · May 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · Blackstone Medical, Inc. · May 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · Medtronic Sofamor Danek, Inc. · May 2001
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965 · Howmedica Osteonics Corp. · May 2000
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
K000876 · Interpore Cross Intl. · Apr 2000
MODIFICATION TO TSRH SPINAL SYSTEM
K000991 · Medtronic Sofamor Danek, Inc. · Apr 2000