Cleared Traditional

K950009 - POWERGRIP(TM) COMPRESSION FIXATION DEVICE

K950009 is an FDA 510(k) clearance for POWERGRIP(TM) COMPRESSION FIXATION DEVICE, manufactured by Synvasive Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K950009 · Synvasive Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K950009

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.

JDW Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K950009.
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
K960023 · Promex, Inc. · Mar 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
ORTHOPEDIC THREADED PIN FIXATION
K932349 · Osteomed Corp. · Mar 1994