Cleared Special

K100532 - VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819

K100532 is an FDA 510(k) clearance for VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, manufactured by Depuy Mitek, A Johnson & Johnson Company. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 20-day FDA review.

K100532 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
20d
Days
Class 2
Risk

K100532 is an FDA 510(k) clearance for the VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on March 17, 2010 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100532

510(k) Number K100532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2010
Decision Date March 17, 2010
Days to Decision 20 days
Submission Type Special
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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K100532.
EXTREMITY MEDICAL SCREW SYSTEM
K093770 · Extremity Medical, LLC · Apr 2010
OPUS SPEEDSCREW SYSTEM
K100457 · Arthrocare Corp. · Mar 2010
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676 · TriMed, Inc. · Mar 2010
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
K092754 · Small Bone Innovations, Inc. · Jan 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909 · Synthes (Usa) · Jan 2010
FOOT AND HAND MOTION SYSTEM
K091118 · Newclip Technics · Dec 2009
K100532 · VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
Download PDF FDA Summary Depuy Mitek, A Johnso…