Cleared Traditional

K962616 - SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM

K962616 is an FDA 510(k) clearance for SYNTHES DORSAL DISTAL RADIUS PLATE (DDR..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K962616 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
62d
Days
Class 2
Risk

K962616 is an FDA 510(k) clearance for the SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM. 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 3, 1996 after a review of 62 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

FDA 510(k) Submission Details - K962616

510(k) Number K962616 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 03, 1996
Decision Date September 03, 1996
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1224
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K962616.
KINAMED PROFIX SYSTEM
K964362 · Kinamed, Inc. · Jan 1997
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K962894 · Synthes (Usa) · Dec 1996
SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
K963798 · Synthes (Usa) · Nov 1996
R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
K961496 · Howmedica, Inc. · Jun 1996
PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K961497 · Howmedica, Inc. · Jun 1996
PLAMP, PLAMP PLATE, PLAMP WITH HOOK
K942032 · Hospital For Special Surgery · Jun 1996