Cleared Traditional

POWERGRIP(TM) COMPRESSION FIXATION DEVICE (K950009) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950009 · Synvasive Technology, Inc. · Orthopedic device
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Aug 1995
Decision
227d
Days
Class 2
Risk

K950009 is an FDA 510(k) clearance for the POWERGRIP(TM) COMPRESSION FIXATION DEVICE. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Synvasive Technology, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 227 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Synvasive Technology, Inc. devices

Submission Details

510(k) Number K950009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1995
Decision Date August 18, 1995
Days to Decision 227 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JDW Pin, Fixation, Threaded

All 38
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K950009.
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K963973 · Depuy, Inc. · Dec 1996
RIGIDYNE A EXTERNAL FIXATION SYSTEM
K955780 · Zimmer, Inc. · Feb 1996
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
K954630 · Depuy, Inc. · Dec 1995
CANNULATED PLUS HIP SCREW
K952640 · Wrightmedicaltechnologyinc · Jul 1995
CROSS PIN SCREW SYSTEM
K946228 · Depuy, Inc. · May 1995
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM
K861766 · Howmedica Corp. · Jul 1986