Cleared Traditional

K953607 - TITANIUM LIMITED CONTACT DYNAMIC HIP SC...

K953607 is the FDA 510(k) clearance for TITANIUM LIMITED CONTACT DYNAMIC HIP SC... by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDO) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K953607 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 1996
Decision
219d
Days
Class 2
Risk

K953607 is an FDA 510(k) clearance for the TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS). Classified as Device, Fixation, Proximal Femoral, Implant (product code JDO), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 8, 1996 after a review of 219 days - an extended review 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: 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 Synthes (Usa) devices

Submission Details

510(k) Number K953607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1995
Decision Date March 08, 1996
Days to Decision 219 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
97d slower than avg
Panel avg: 122d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDO Device, Fixation, Proximal Femoral, Implant
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 - JDO Device, Fixation, Proximal Femoral, Implant

All 17
Devices cleared under the same product code (JDO) and FDA review panel - the closest regulatory comparables to K953607.
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · Smith & Nephew, Inc. · Apr 2008
SYNTHES (USA) DHS HELIX SYSTEM
K981757 · Synthes (Usa) · Jul 1998
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
K964259 · Synthes (Usa) · Jan 1997
SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]
K951904 · Synthes (Usa) · Jul 1995
PROFORM HIP SYSTEM
K934161 · Stelkast Company · Mar 1994
PROFORM HA HIP SYSTEM
K934162 · Stelkast Company · Mar 1994