Cleared Traditional

K101165 - PRO-TOE VO HAMMERTOW IMPLANT SYSTEM

K101165 is an FDA 510(k) clearance for PRO-TOE VO HAMMERTOW IMPLANT SYSTEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K101165 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
88d
Days
Class 2
Risk

K101165 is an FDA 510(k) clearance for the PRO-TOE VO HAMMERTOW IMPLANT SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 88 days - a notably fast clearance 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: 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K101165

510(k) Number K101165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2010
Decision Date July 23, 2010
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 966
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K101165.
PIONEER CANNULATED SCREW SYSTEM
K102903 · Pioneer Surgical Technology, Inc. · Oct 2010
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
K101700 · Extremity Medical, LLC · Oct 2010
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
K101696 · Zimmer, Inc. · Sep 2010
DARCO HEADED CANNULATED SCREW
K100359 · Wrightmedicaltechnologyinc · Jun 2010
MODIFICATION TO HBS HEADLESS BONE SCREW
K101030 · Biopro, Inc. · Jun 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · Smith & Nephew, Inc. · May 2010