Cleared Traditional

K011335 - SYNTHS ONE-THIRD TUBULAR DCL PLATE

K011335 is the FDA 510(k) clearance for SYNTHS ONE-THIRD TUBULAR DCL PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K011335 · Synthes (Usa) · Orthopedic device
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Jul 2001
Decision
86d
Days
Class 2
Risk

K011335 is an FDA 510(k) clearance for the SYNTHS ONE-THIRD TUBULAR DCL PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 27, 2001 after a review of 86 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 Synthes (Usa) devices

Submission Details

510(k) Number K011335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2001
Decision Date July 27, 2001
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K011335.
WUJIN #3 FEMORAL BONE PLATE
K011459 · Biopro, Inc. · Aug 2001
WUJIN #3 TIBIAL BONE PLATE
K011460 · Biopro, Inc. · Aug 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · Synthes (Usa) · Jul 2001
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
K011076 · Walter Lorenz Surgical, Inc. · Jul 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · Synthes (Usa) · Jul 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788 · Synthes (Usa) · May 2001