Cleared Special

K002710 - MODIFICATION TO SYNTHES (USA) TROCHANTE...

K002710 is the FDA 510(k) clearance for MODIFICATION TO SYNTHES (USA) TROCHANTE... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 29-day FDA review.

K002710 · Synthes (Usa) · Orthopedic device
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Sep 2000
Decision
29d
Days
Class 2
Risk

K002710 is an FDA 510(k) clearance for the MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (L.... 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 September 29, 2000 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes (Usa) devices

Submission Details

510(k) Number K002710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2000
Decision Date September 29, 2000
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K002710.
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237 · Biomet, Inc. · May 2001
PE.R.I. II KNEE FRACTURE SYSTEM
K003235 · DePuy Orthopaedics, Inc. · Nov 2000
SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
K002361 · Synthes (Usa) · Oct 2000
SYNTHES MODULAR FOOT SYSTEM
K001941 · Synthes (Usa) · Sep 2000
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
K001945 · Synthes (Usa) · Sep 2000
LACTOSORB PANELS AND FASTENERS
K984390 · Biomet, Inc. · Aug 2000